510(k) Report

FDA applicant

Precimed, Inc.

Chester Springs, PA2 decisions2003–20050 recalls

FDA records 2 decisions for Precimed, Inc. (Chester Springs, PA) from 2003 to 2005: 2 510(k) clearances. Most are in product codes KTT (Appliance, Fixation, Nail/Blade/Plate…) and HWC (Screw, Fixation, Bone). No 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 Precimed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Precimed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Precimed, Inc. 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?

  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1decision
  • HWCScrew, Fixation, Bone1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K050754Precimed Cannulated Screw SystemPrecimed, Inc. · 20052cite it
  • K023851Precimed Hip Screw SystemPrecimed, Inc. · 20031cites it

What has FDA decided for it lately?

  • K050754Precimed Cannulated Screw SystemPrecimed, Inc. · 2005
  • K023851Precimed Hip Screw SystemPrecimed, Inc. · 2003

All 2 as Precimed, Inc. →