510(k) Report

FDA applicant

Pectofix, Inc.

Metuchen, NJ2 decisions2000–20010 recalls

FDA records 2 decisions for Pectofix, Inc. (Metuchen, NJ) from 2000 to 2001: 2 510(k) clearances. All are in product code JDQ (Cerclage, Fixation). 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 Pectofix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pectofix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pectofix, 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?

  • JDQCerclage, Fixation2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K000694Pectofix Dynamic Sternal Fixation System (DSF)Pectofix, Inc. · 20001cites it

What has FDA decided for it lately?

  • K003951Pectofix Sternal Repair WirePectofix, Inc. · 2001
  • K000694Pectofix Dynamic Sternal Fixation System (DSF)Pectofix, Inc. · 2000

All 2 as Pectofix, Inc. →