RetiredUnitedHealthcarePolicy CS009LA.Q

Spinal fusion biologics and graft materials

This policy governs coverage and medical necessity determinations for biologic products and bone graft materials used to enhance spinal fusion for UnitedHealthcare Community Plan members in Louisiana.

Policy Summary

PayerUnitedHealthcare

PolicySpinal fusion biologics and graft materials

Policy CodePolicy CS009LA.Q

Change TypeRetirementcoverage clarifications

Effective DateJan 1, 2026

Next Review Date

Key ActionVerify benefit coverage and obtain prior authorization when required; ensure medical records fully document medical necessity.

SourceLink

POLICY UPDATE CHANGES

Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026.

Added language to clarify Ceramic-Based Products (e.g., beta tricalcium phosphate [b-TCP], calcium phosphate, calcium sulfate) used alone or in combination with other grafts and/or graft components, including Bone Marrow Aspirate (BMA), are unproven and not medically necessary.

Added documentation expectations indicating medical records may be required to assess clinical criteria and must fully support medical necessity.

L2-S1lumbar levels specified for InFUSE coverage

single levelInFUSE covered only for single-level fusion

age ≥ 18skeletally mature requirement

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

limited evidenceproducts with insufficient comparative data

1policy history entry 04/01/2026

Coverage Criteria for Spinal Fusion Biologics and Graft Materials

InFUSE (rhBMP-2) - Lumbar interbody

Covered when ALL of the following are met for InFUSE in lumbar interbody fusion:

InFUSE lumbar interbody coverage: Approach is anterior or oblique AND used in conjunction with an FDA‑approved interbody fusion device; patient is skeletally mature (18 years of age or older or radiographic evidence of epiphyseal closure); diagnosis of degenerative disc disease (DDD); fusion involves vertebral bodies L2–S1 with no more than grade 1 spondylolisthesis at the involved level; fusion is single level.

From policy coverage rationale; preserve AND logic as stated.

InFUSE/MASTERGRAFT - Posterolateral revision

Covered when ALL of the following are met for InFUSE/MASTERGRAFT posterolateral revision device:

InFUSE/MASTERGRAFT posterolateral revision coverage: Implanted via a posterolateral approach; presence of symptomatic posterolateral lumbar spine pseudoarthrosis; skeletally mature patient (older than 21 years or radiographic evidence of epiphyseal closure); autologous bone and/or bone marrow harvest is not feasible or is not expected to promote fusion.

Coverage limited to FDA indications and those criteria.

Covered vs Unproven product groups

Covered and not covered product categories:

Proven/covered for enhancement of spinal fusion: Autografts (including Bone Marrow Aspirate); Demineralized Bone Matrix (DBM) when not combined with products listed as unproven; Allograft-based products not specifically listed as unproven; InFUSE for the specified lumbar indication; InFUSE/MASTERGRAFT per FDA indications for posterolateral revision when criteria are met.

Policy lists these as proven and medically necessary.

Unproven and not medically necessary: Allograft-based cell products (eg, mesenchymal stem cell preparations); human amniotic tissue materials including amniotic fluid stem cell substitutes; rhBMP-2 (InFUSE) and InFUSE/MASTERGRAFT for indications other than those specified above; ceramic-based products (eg, beta tricalcium phosphate, calcium phosphate, calcium sulfate) used alone or in combination with other grafts or components including Bone Marrow Aspirate (BMA); bioactive glass used alone or in combination; expandable interbody fusion systems.

Policy explicitly lists these as unproven and not medically necessary due to insufficient evidence.

Coverage evidence considerations

Evidence-derived coverage considerations

rhBMP-2 lumbar use: Randomized trials and systematic reviews show rhBMP-2 (InFUSE) can increase fusion rates for lumbar fusion compared with autograft and may reduce operative time and blood loss; however, methodological limitations and variable reporting of clinical outcomes limit definitive superiority conclusions.evidence: RCTs and meta-analyses

See Fitzgerald et al. and Liu et al. systematic reviews and RCT data.

rhBMP-2 cervical use: Systematic reviews and ECRI assessments identify higher rates of serious adverse events when rhBMP-2 is used for cervical fusion; FDA warnings indicate off-label cervical use can cause life‑threatening complications and risks may outweigh benefits.safety signal

ECRI and FDA safety concerns documented for cervical use.

Other osteobiologics (allograft, cell-based, amniotic, ceramic):

Coverage guidance — general

Summary stance based on cited evidence

Evidence-based coverage considerations: When high-quality, product‑specific randomized controlled trial data exist, coverage may be considered in alignment with those findings; for many ceramic-based products and bioactive glass, available evidence is insufficient or low quality and should be treated as investigational. Where small RCTs or intra‑patient noninferiority trials suggest comparable fusion rates for specific products, limitations (small sample size, short follow-up, heterogeneity, potential bias) must be considered before extending coverage broadly.

Apply product-specific evidence; otherwise consider investigational status.

Evidence summaries and society recommendations

Evidence summaries and professional society recommendations relevant to coverage decisions

Bioactive glass evidence: Retrospective case series of BioSphere Putty (248 patients) reported high radiographic fusion rates and substantial VAS score reductions at 1–2 years but is limited by retrospective design, high risk of bias, and small long‑term follow‑up; higher‑quality studies are needed.

Study limited by bias and limited 2‑year follow up.

Expandable interbody systems evidence: Systematic reviews and meta-analyses report that expandable cages may improve radiographic parameters (eg, disc height, segmental lordosis) but do not show consistent clinical benefit; overall evidence quality is very low to low and randomized trials are lacking.

Multiple SRs report mixed radiographic benefits without consistent improvements in pain/ODI.

rhBMP-2 guidance: Professional society guidance (AANS/NASS) recognizes that rhBMP-2 may be an adjunct in specific high‑risk fusion scenarios but advises against routine use in anterior and posterior cervical fusion, single‑level posterior/posterolateral fusions in healthy adults, and routine pediatric spine fusion procedures.

Coverage Rationale and Documentation Criteria

Coverage and medical necessity determinations reference federal, state, or contractual benefit limitations and require supporting medical record documentation.

Ceramic-based products and BMA: Ceramic-based products (eg, beta tricalcium phosphate, calcium phosphate, calcium sulfate) used alone or in combination with other grafts and/or graft components, including Bone Marrow Aspirate (BMA), are considered unproven and not medically necessary.

From policy summary of changes indicating unproven/Not medically necessary status.

Documentation requirement: The patient's medical record must contain documentation that fully supports the medical necessity for the requested services, including relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures; records must be legible and made available upon request.

Documentation expectations added to policy.

Benefit governance: Benefit coverage is governed by applicable federal, state, or contractual requirements; these requirements supersede this policy when conflicts exist and should be checked prior to applying the policy.

Per the policy, recombinant human bone morphogenetic protein-2 (rhBMP-2, e.g., InFUSE) and the InFUSE/MASTERGRAFT Posterolateral Revision Device are considered unproven and not medically necessary when used for any indications other than those specifically listed as covered in this policy. Use outside the specified FDA‑approved or policy-defined indications is therefore excluded from coverage.

The policy lists several product classes as unproven and not medically necessary for enhancement of spinal fusion: cell-based allograft products (e.g., mesenchymal stem cell–containing allografts), human amniotic tissue materials (including amniotic fluid stem cell substitutes), and a range of synthetic substitutes such as ceramic-based products. The brief and evidence assessments note limited or no high-quality comparative data for specific products (for example, PrimaGen, OsteoAMP), supporting the policy’s noncoverage stance for these categories.

The document highlights that use of rhBMP-2 for cervical fusion is associated with life‑threatening adverse events and is outside the FDA‑approved spinal indication (Infuse is approved for L2–S1). Professional assessments and the FDA warning support that off‑label cervical use carries significant safety concerns and should be treated differently from approved lumbar use when making authorization decisions.

The policy states that products lacking adequate, high‑quality clinical evidence to determine safety and efficacy are considered investigational or unproven. This includes many ceramic and bioactive glass products and expandable interbody systems for which the literature is limited, heterogeneous, or of very low quality.

While the policy does not present an exhaustive exclusion list in one place, it explicitly notes that products without adequate evidence may be considered investigational or unproven. Additionally, society statements and FDA advisories (for example, regarding off‑label rhBMP‑2 cervical use) are referenced to inform risk and coverage judgments.

The policy clarifies that ceramic-based products (e.g., beta tricalcium phosphate, calcium phosphate, calcium sulfate) used alone or combined with other grafts or components including Bone Marrow Aspirate (BMA) are considered unproven and not medically necessary. This change is reflected in the policy revision language and is grounded in the assessment that available clinical evidence is insufficient to support routine coverage.

Consistent with the policy, allograft-based cell products, human amniotic tissue materials, and rhBMP-2/InFUSE used outside specified indications are described as unproven or not medically necessary. These categories are called out based on limited comparative effectiveness data and safety concerns identified in evidence assessments.

The policy provides examples of products with insufficient clinical evidence to support coverage decisions, noting items such as PrimaGen Advanced Allograft and OsteoAMP among allograft/cell‑based products; these examples are cited from ECRI evidence assessments that found limited or no comparative studies to autograft or established substitutes.

Ceramic‑based products and expandable interbody fusion systems are characterized in the policy as having insufficient or very low‑quality evidence for determining safety and efficacy. The assessments emphasize heterogeneity in composition and limited high‑quality trials, which supports treating many such products as investigational.

Expandable interbody fusion systems are described as unproven because the literature lacks prospective randomized controlled trials with larger sample sizes and longer‑term follow‑up. Systematic reviews and meta‑analyses to date show mixed radiographic findings but no consistent clinical superiority, and overall evidence quality is low.

The policy restates that ceramic-based products (b-TCP, calcium phosphate, calcium sulfate) used alone or in combination with other graft materials, including Bone Marrow Aspirate (BMA), are unproven and not medically necessary. This clarification is an explicit policy revision intended to standardize the coverage stance for these product classes.

Procedure and Device Coding References

Procedure codes referencedCPT

0814T	Percutaneous injection of calcium-based biodegradable osteoconductive material, proximal femur, including imaging guidance, unilateral.
20930	Allograft, morselized, or placement of osteopromotive material, for spine surgery only (List separately in addition to code for primary procedure).
20931	Allograft, structural, for spine surgery only (List separately in addition to code for primary procedure).
20939	Bone marrow aspiration for bone grafting, spine surgery only, through separate skin or fascial incision (List separately in addition to code for primary procedure).
22899	Unlisted procedure, spine

No explicit codes in this sectionmixed

No codes listed

FDA-cleared devices mentioned (no billing codes listed)mixed

No codes listed

Actions Required by Providers / Prior Authorization & Documentation

Prior Authorization

Code List & Prior Authorization Note

The following code list is provided for reference only. Inclusion of a code in this policy does not indicate that the service is covered. Benefit coverage and prior authorization requirements are determined by the member's federal, state, or contractual benefit plan; providers must verify member benefits and obtain any required prior authorization before delivering services.

Codes listed in the policy (e.g., 0814T, 20930, 20931, 20939, 22899) are for reference only and are not a guarantee of coverage or payment.
Providers must check member-specific benefit documents and payer portals for prior authorization requirements and submitting documentation.

Prior Authorization

Prior Authorization for High‑Risk Off‑Label Osteobiologics

Off-label use of high-risk osteobiologics (for example, rhBMP-2 used in the cervical spine) may be associated with life‑threatening adverse events and is frequently discouraged. Prior authorization is recommended/required for off-label, high-risk osteobiologic use and may be denied based on safety concerns.

Infuse (rhBMP-2) is FDA-approved only for certain lumbar indications (L2–S1); cervical use is off-label and has documented airway/neurologic compression risks.

Clinical Background and Evidence Context

Autologous iliac crest bone graft remains the gold standard for spinal fusion because it provides osteoconductive, osteoinductive, and osteogenic properties. The policy notes this clinical context while acknowledging donor‑site morbidity and that certain substitutes are considered in defined circumstances where autograft is not feasible.

Definitions and Terminology

Allograft — definition entry

DefinitionTransplant of an organ or tissue from one individual to another of the same species with a different genotype (allogeneic graft). Also known as an allograft or homograft.

Regulatory noteAllografts are regulated as human cells, tissues, and cellular and tissue-based products (HCT/P); combining with other materials may reclassify the product as a device.

Clinical useUsed as structural (cortical or corticocancellous) or nonstructural grafts in spinal fusion, often as an alternative to autograft when harvest morbidity is a concern.

Autograft — definition entry

DefinitionTissue grafted into a new position in the body of the same individual (autologous graft).

Clinical roleIliac crest bone autograft (ICBG) remains the gold standard for structural and nonstructural spine fusion despite donor-site morbidity.

Policy Revision History

2026-04-01retirementLatest

Policy retired for Louisiana; Louisiana plan membership disenrolled on Apr. 1, 2026.

The revision history summarizes both material and non‑material changes: a material clarification was added stating that ceramic-based products and Bone Marrow Aspirate (BMA) used alone or in combination are unproven and not medically necessary, operational changes note retirement of the policy for Louisiana membership effective 04/01/2026, and non‑material edits include added documentation expectations and updated definitions and references.

Policy Summary

PayerUnitedHealthcare

PolicySpinal fusion biologics and graft materials

Policy CodePolicy CS009LA.Q

Change TypeRetirementcoverage clarifications

Effective DateJan 1, 2026

Next Review Date

Key ActionVerify benefit coverage and obtain prior authorization when required; ensure medical records fully document medical necessity.

SourceLink

On This Page

Most alternative osteobiologic products (cell-based allografts, human amniotic tissue materials, many ceramic-based products, bioactive glass, and expandable systems) have limited, low-quality, or heterogeneous evidence and lack consistent comparative data versus autograft; larger, well‑designed trials are required to establish safety and efficacy.

Supported by ECRI and multiple systematic reviews noting insufficient comparative data.

Society statements enumerate indications and contraindications.

Allograft/DBM/HA guidance: AANS/NASS guidelines support DBM, HA/b-TCP and certain allograft uses as options or substitutes for iliac crest bone graft in defined fusion settings (eg, single‑level posterolateral or interbody fusions) while noting ICBG remains the gold standard.

Recommendations vary by fusion type and patient risk factors.

Instructional operational requirement.

Prior authorization submissions for off-label rhBMP-2 should include clinical rationale, alternative treatments considered (e.g., autograft), and risk mitigation.

Expect denials or additional review for cervical spine rhBMP-2 due to documented increased adverse event rates.

Prior Authorization

Prior Authorization Advisable for Expandable Implants

Expandable interbody fusion implants and other new implantable systems currently have limited high-quality evidence for clinical benefit. Prior authorization is advisable and may require submission of device-specific evidence, comparative outcomes, and rationale for use over established alternatives.

Evidence for expandable systems is low-quality and largely retrospective; randomized controlled trial data are lacking.
Prior authorization requests should include device model, FDA clearance/510(k)/De Novo details, indication, and supporting clinical outcomes demonstrating advantage over static cages.
Without strong supporting evidence, requests may be denied or considered investigational.

Prior Authorization

Verify Benefit Coverage & Prior Authorization

Verify member benefit coverage, applicable federal/state/contractual requirements, and any prior authorization or medical-record submission requirements before applying this policy to coverage decisions.

Benefit coverage is governed by the member's plan documents and applicable laws; policy language alone does not determine coverage.
Confirm whether the member's plan requires prior authorization, network restrictions, or additional criteria.

Denial Risk

rhBMP‑2 Off‑Label Cervical Use Risk

rhBMP-2 has documented increased adverse events when used off-label in the cervical spine, including potentially life‑threatening airway and neurologic complications. Off-label cervical use is discouraged and may not be approved.

FDA public communications have warned about life-threatening complications with rhBMP-2 in cervical fusions.
Prior authorization and thorough documented justification are expected for any request involving cervical rhBMP-2; such requests may be denied.

Denial Risk

Use of Ceramic‑Based Products May Be Unproven

Ceramic-based products (e.g., beta‑tricalcium phosphate, calcium phosphate, calcium sulfate, SiCaP) have mixed and insufficient evidence for many indications. Use alone or combined with Bone Marrow Aspirate (BMA) may be considered unproven and not medically necessary per this policy.

Clinical studies are heterogeneous and often insufficient to establish superiority or equivalence to autograft.
When ceramic-based products are proposed for use in posterolateral fusion or interbody procedures, provide comparative evidence and rationale; absence of supportive data may lead to denial.

Denial Risk

Evidence Insufficiency for Expandable Systems

Current evidence for expandable interbody systems is insufficient—most data are retrospective with potential bias and lack robust patient‑centered outcomes. This evidence insufficiency supports investigational determinations absent stronger clinical trial data.

Systematic reviews report no clear clinical advantage of expandable versus static cages and note low evidence quality.
Provide high-quality comparative outcomes (pain, function, fusion by CT) when requesting coverage for expandable systems; otherwise the device may be considered investigational.

Denial Risk

Denial Risk for Ceramic Products and BMA

Ceramic-based products used alone or combined with Bone Marrow Aspirate (BMA) have been determined unproven and not medically necessary in this policy. Use of these materials risks denial if documentation does not justify necessity or demonstrate clinically meaningful benefit.

Requests for coverage involving ceramic products ± BMA should include objective evidence (e.g., comparative fusion rates by CT, PROMs) supporting their use over autograft or established allograft/DBM options.
Lack of such documentation may result in denial as not medically necessary.

Documentation Required

Imaging & Outcomes Documentation

Document imaging and outcomes to support fusion claims and clinical benefit. Radiographic fusion assessment (preferably CT-based) and patient-reported outcome measures are commonly used to demonstrate treatment success.

Include CT or other appropriate imaging reports assessing fusion at defined intervals (e.g., 6, 12, 24 months) when applicable.
Provide PROMs such as Oswestry Disability Index (ODI), Visual Analog Scale (VAS), or NRS scores to document functional improvement.
When ceramic substitutes or novel devices are used in posterolateral fusion (PLF), document CT-based fusion assessments and outcomes per policy guidance.

Documentation Required

Document FDA‑Cleared Device & Indication

When coverage is sought for a specific device, document the FDA clearance/approval status and the device indication. Include device-specific identifiers to facilitate review.

Provide FDA 510(k), PMA, De Novo, or HDE identifier and supporting FDA summary when available (e.g., OptiMesh, Duo, InFUSE/LT‑CAGE approvals referenced in policy).
If the device is being used outside its labeled indication, clearly document the clinical rationale and supporting evidence.

Note

Provider Action Not Otherwise Specified

Provider action unspecified in this document: when the policy or plan requires additional provider steps beyond those already specified (e.g., forms, imaging timing, peer-to-peer), follow payer instructions in the member's benefit plan or prior authorization workflow.

If the payer's prior authorization process requests additional documentation not enumerated here, submit all requested materials in a timely manner.
Contact the payer's provider services or prior authorization unit for clarification when required actions are unclear.

Note

Consider Autograft Before Substitute

Autograft (e.g., iliac crest bone graft) is generally considered the reference standard. Consider autograft before using substitutes or adjunctive osteobiologics when clinically feasible.

Many comparative studies and systematic reviews use autograft/ICBG as the reference standard; payers may expect autograft to be considered prior to substituting with newer products.
Document why autograft is not feasible or appropriate if requesting coverage for substitutes (e.g., comorbidity, prior harvest morbidity).

Note

Evidence Comparisons Frequently Use Autograft (ICBG) as Reference

Evidence comparisons frequently use autograft (ICBG) as the reference. Prior authorization or medical necessity reviews may expect comparative data versus autograft when evaluating substitutes or biologics.

Submit comparative fusion data (fusion rates, reoperation rates) and patient outcomes versus ICBG when available to support requests for substitutes.
If autograft was not used, document the clinical justification and available alternative evidence used to support the chosen graft/substitute.

ConsiderationHarvest morbidity (eg, pain, infection, fracture, chronic donor‑site pain) motivates use of alternatives in some patients.

InFUSE Bone Graft (rhBMP-2) — definition entry

ProductInFUSE™ Bone Graft contains recombinant human bone morphogenetic protein-2 (rhBMP-2) delivered on an absorbable collagen sponge to stimulate bone formation.

FDA indicationInfuse is FDA-approved for certain spine, dental, and trauma indications; specifically for lumbosacral fusion L2–S1 in the spine context.

Clinical intentIntended to achieve vertebral fusion by promoting natural bone growth and to avoid the need for autologous bone graft harvest.

Demineralized Bone Matrix (DBM) — definition entry

DefinitionDemineralized bone matrix (DBM) is an allograft produced by dissolving the mineralized portion of bone and leaving the collagen matrix and retained growth factors.

PropertiesThe collagen matrix provides weak osteoconductive capacity while retained growth factors are osteoinductive; DBM generally requires a carrier to provide a potent osteoconductive scaffold.

Clinical useDBM is used as an adjunct in spinal fusion, often combined with autograft or other carriers rather than as a standalone scaffold.

Bioactive Glass — definition entry

DefinitionBioactive glass refers to silicate glass-based materials with osteoconductive and osteoinductive properties used as bone graft substitutes.

CompositionTypically composed of oxides such as SiO2, CaO, Na2O, and P2O5 and designed to promote hydroxyl carbonated apatite formation and bone bonding.

EvidenceThere is insufficient high-quality evidence to conclude efficacy and safety compared with established grafts; further studies are needed.

rhBMP-2 (Infuse) — definition entry

TermrhBMP-2 (Infuse) is recombinant human bone morphogenetic protein-2, an osteoinductive growth factor delivered on a collagen sponge (InFUSE).

Intended effectPromotes differentiation of local mesenchymal stem cells into osteoblasts to stimulate bone formation and fusion.

Safety/indication noteInfuse is FDA-approved for lumbosacral fusion L2–S1; off-label cervical use has been associated with life‑threatening adverse events per FDA and evidence reviews.

Allograft and cell-based products — definition entry

DefinitionAllograft and cell-based products are grafts derived from donated human bone or containing preserved bone-forming cells (eg, PrimaGen, OsteoAMP, Osteocel).

EvidencePublished evidence for many cell‑based allograft products is limited in quantity and quality; comparative effectiveness versus autograft is not established.

Clinical implicationUse may be considered investigational or unproven when robust comparative data are lacking; product-specific studies are needed.

Ceramic-based products — definition entry

DefinitionCeramic-based products are synthetic bone graft substitutes composed of mineral salts such as hydroxyapatite, calcium phosphate, and tricalcium phosphate (including doped variants).

CharacteristicsThey vary widely in composition, porosity, manufacturing, and resorption characteristics, influencing clinical outcomes.

Evidence stanceThere is insufficient high-quality evidence to determine safety and efficacy for many ceramic-based products; some are considered unproven/not medically necessary when used alone or with BMA.

Bioactive glass — definition entry

DefinitionBioactive glass (synthetic silica-based bone graft material) is composed of oxides (eg, SiO2, CaO, Na2O, P2O5) designed to promote bone bonding and HCA formation.

Claimed propertiesAdvertised to have faster hydroxyl carbonated apatite formation and higher osteoconductivity compared with calcium phosphates and HA/TCP.

Evidence summaryCurrent literature lacks sufficient high‑quality evidence to determine comparative efficacy and safety; conclusions are uncertain.

Expandable interbody fusion systems — definition entry

DefinitionExpandable interbody fusion systems are interbody implants that expand in situ to restore disc height and provide structural support.

Device examplesIncludes implants such as OptiMesh, Duo™ Ti, and other expandable cage systems designed for anatomy-conforming placement and graft containment.

Evidence noteEvidence is limited and of very low to low quality; randomized trials with larger samples and longer follow-up are lacking, so these systems are considered unproven for some indications.

Structural allograft — definition entry

DefinitionStructural allograft refers to cortical or corticocancellous allograft bone (fresh-frozen or freeze-dried) used to provide structural support in spinal reconstruction and fusion.

IndicationsIndicated for anterior cervical reconstruction (ACDF, corpectomy), posterior cervical fusion, interbody fusion (TLIF/PLIF/ALIF), and thoracolumbar fusion when structural support is required.

Use considerationMay be used with or without additional autograft or synthetic cages depending on surgical scenario and fixation strategy.

Allograft regulatory status — definition/regulatory note

Regulatory classificationAllografts are regulated as human cells, tissues, and cellular and tissue-based products (HCT/P) under FDA regulation.

Device reclassificationIf an allograft is combined with other materials, the combined product may be regulated as a device by the FDA rather than as an HCT/P.

ReferenceSee FDA tissue and tissue products guidance and device databases for product-specific regulatory information and 510(k)/PMA references.

Osseointegration — added/updated definition in policy

Definition addedOsseointegration: the stable anchorage of an implant achieved by direct bone-to-implant contact.

ContextAdded to policy definitions to clarify implant–bone contact and fixation relevant to fusion device performance.

SourceAlbrektsson (2001) definition as cited in the policy.

Osteoconduction — added/updated definition in policy

Definition addedOsteoconduction: bone grows on the surface (providing a scaffold for new bone growth).

Clinical relevanceDescribes scaffold function of graft materials (eg, DBM carriers, ceramics) that permit host bone in-growth.

SourceAlbrektsson (2001) definition as cited in the policy.

Osteoinduction — added/updated definition in policy

Definition addedOsteoinduction: the process by which osteogenesis is induced via recruitment and stimulation of immature cells to develop into preosteoblasts.

Clinical relevanceRefers to the biologic activity of agents such as BMPs and retained growth factors in DBM that stimulate new bone formation.

SourceAlbrektsson (2001) definition as cited in the policy.

Allograft / Autograft / Bone Marrow Aspiration — updated definitions

Definitions updatedPolicy updated definitions for Allograft, Autograft, and Bone Marrow Aspiration to clarify terms and clinical implications in the context of spinal fusion.

Bone Marrow AspirationDefined in policy as removal of a small amount of marrow (liquid form) from bone for grafting or examination; updates reflect terminology and procedural context.

Operational noteDefinitions revisions are part of the January 1, 2026 and April 1, 2026 policy changes; consult policy history for revision details.