510(k) Report

FDA applicant

Osteotech, Inc.

Eatontown, NJ24 decisions1985–200834 recalls

FDA records 24 decisions for Osteotech, Inc. (Eatontown, NJ) from 1985 to 2008: 24 510(k) clearances. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and MQV (Filler, Bone Void, Calcium Compound). Its devices cite 23 predicates, 5 of them its own earlier devices. 34 recalls are linked to its devices, 1 Class I.

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 Osteotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2008

2007: 12008: 4
2007high 4 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2026

2011: 22012: 13, 1 Class I2014: 12023: 162026 (partial year): 2
2007high 16 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • KWPAppliance, Fixation, Spinal Interlaminal5decisions
  • MQVFiller, Bone Void, Calcium Compound4decisions
  • MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)4decisions
  • MQPSpinal Vertebral Body Replacement Device4decisions
  • NUNBone Grafting Material, Human Source2decisions
  • HWCScrew, Fixation, Bone1decision

Also: LRP (1), KIT (1), MNH (1), LYC (1).

Whose devices does it build on?

Its devices cite 23 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 50 times; 5 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.

  • K012254VBROsteotech, Inc. · 200118cite it
  • K051195Grafton DBMOsteotech, Inc. · 200511cite it
  • K003155Vertebral Body ReplacementOsteotech, Inc. · 20017cite it
  • K051188Grafton DBMOsteotech, Inc. · 20065cite it
  • K082615Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler DevicesOsteotech, Inc. · 20083cite it
  • K955173SSCS (Segmental Spinal Correction System)Osteotech, Inc. · 19962cite it

What has FDA decided for it lately?

  • K082615Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler DevicesOsteotech, Inc. · 20081 recall
  • K081227Plexur MOsteotech, Inc. · 2008
  • K080511Plexur-POsteotech, Inc. · 2008
  • K073405Plexur MOsteotech, Inc. · 2008
  • K061982Plexur POsteotech, Inc. · 2007
  • K051188Grafton DBMOsteotech, Inc. · 200614 recalls
  • K051195Grafton DBMOsteotech, Inc. · 200530 recalls
  • K051781Graftcage TLXOsteotech, Inc. · 20051 Class I recall

All 24 as Osteotech, Inc. →

What has been recalled?

34 recalls linked to its devices; the latest:

  • K042707Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with…Aug 12, 2026Class II
  • K051188Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with…Aug 12, 2026Class II
  • K051195Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone MatrixSep 26, 2023Class II
  • K051195Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone MatrixSep 26, 2023Class II
  • K051195Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone MatrixSep 26, 2023Class II
  • K051195Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150…Sep 26, 2023Class II