510(k) Report

FDA applicant

Osteobiologics, Inc.

San Antonio, TX9 decisions2002–20051 recall

FDA records 9 decisions for Osteobiologics, Inc. (San Antonio, TX) from 2002 to 2005: 9 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and FTL (Mesh, Surgical, Polymeric). Its devices cite 9 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Osteobiologics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Osteobiologics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Osteobiologics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Osteobiologics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MQVFiller, Bone Void, Calcium Compound3decisions
  • FTLMesh, Surgical, Polymeric2decisions
  • HRXArthroscope1decision
  • JDKProsthesis, Hip, Cement Restrictor1decision
  • NGRTester, Stiffness, Cartilage, Arthroscopic1decision
  • FMFSyringe, Piston1decision

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K030288Polygraft Bone Graft SubstituteOsteobiologics, Inc. · 20036cite it
  • K040047Polygraft BGS; Bone Graft SubstituteOsteobiologics, Inc. · 20044cite it
  • K032673Immix PlastifilmOsteobiologics, Inc. · 20032cite it
  • K033707Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX…Osteobiologics, Inc. · 20042cite it
  • K024199Immix Thin Film, Models: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LPOsteobiologics, Inc. · 20031cites it

What has FDA decided for it lately?

  • K051656Oct (Osteochondral Transplant) Comprehensive SystemOsteobiologics, Inc. · 2005
  • K041382Polygraft BGS; Bone Graft SubstituteOsteobiologics, Inc. · 2005
  • K043172Trugraft BGS Syringe, Model 600-041Osteobiologics, Inc. · 2005
  • K040047Polygraft BGS; Bone Graft SubstituteOsteobiologics, Inc. · 20041 recall
  • K033707Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX…Osteobiologics, Inc. · 2004
  • K032673Immix PlastifilmOsteobiologics, Inc. · 2003
  • K030288Polygraft Bone Graft SubstituteOsteobiologics, Inc. · 2003
  • K024199Immix Thin Film, Models: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LPOsteobiologics, Inc. · 2003

All 9 as Osteobiologics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K040047TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-001-03; product labeled as…Sep 29, 2006