510(k) Report

FDA applicant

Osteomedics, Inc.

Paramus, NJ10 decisions2001–20031 recall

FDA records 10 decisions for Osteomedics, Inc. (Paramus, NJ) from 2001 to 2003: 10 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and JEY (Plate, Bone). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Osteomedics”.

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

FDA decisions per year

No FDA decision for Osteomedics, Inc. since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Osteomedics, 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?

  • HRSPlate, Fixation, Bone6decisions
  • JEYPlate, Bone4decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 0 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.

  • K022325Normed Titanium Osteotomy Plating SystemOsteomedics, Inc. · 20025cite it
  • K022324Normed Titanium Calcaneus Plating with Locking Screw SystemOsteomedics, Inc. · 20024cite it
  • K011118Normed Extremity Titanium Hand and Small Fragment SystemOsteomedics · 20012cite it
  • K022231Normed Distal Radius Reconstruction SystemOsteomedics, Inc. · 20021cites it
  • K022035Osteomedics Resorbable Small Fixation System, OsteosorbOsteomedics, Inc. · 20031cites it

What has FDA decided for it lately?

  • K022035Osteomedics Resorbable Small Fixation System, OsteosorbOsteomedics, Inc. · 2003
  • K022324Normed Titanium Calcaneus Plating with Locking Screw SystemOsteomedics, Inc. · 20021 recall
  • K022231Normed Distal Radius Reconstruction SystemOsteomedics, Inc. · 2002
  • K022230Normed Mini External Fixator SystemOsteomedics, Inc. · 2002
  • K022323Normed Titanium Rondo Fix Fusion Plates and Screw SystemOsteomedics, Inc. · 2002
  • K022325Normed Titanium Osteotomy Plating SystemOsteomedics, Inc. · 20021 recall
  • K021341Normed Bone Transport Distraction DeviceOsteomedics, Inc. · 2002
  • K021342Normed BI-Directional/Multidirectional Jaw DistractorOsteomedics, Inc. · 2002

All 9 as Osteomedics, Inc. →The one decision as Osteomedics →

What has been recalled?

1 recall linked to its devices; the latest:

  • K022324Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog…Apr 14, 2009