510(k) Report

FDA applicant

Medpac

Valencia, CA3 decisions1991–19951 recall

FDA records 3 decisions for Medpac (Valencia, CA) from 1991 to 1995: 3 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). 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 Medpac’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medpac since 2007.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone1decision
  • HWCScrew, Fixation, Bone1decision
  • JDSNail, Fixation, Bone1decision

Who builds on its devices?

Later devices cite its devices 9 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.

  • K951303SFCMedpac · 19956cite it
  • K951302Small Fragment Plates and ScrewsMedpac · 19953cite it

What has FDA decided for it lately?

  • K951303SFCMedpac · 1995
  • K951302Small Fragment Plates and ScrewsMedpac · 19951 recall
  • K903697Hawaiian Supracondylar PlateMedpac · 1991

All 3 as Medpac →

What has been recalled?

1 recall linked to its devices; the latest:

  • K951302TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert…Aug 24, 2018Class II