510(k) Report

FDA applicant

Jace Medical, LLC

Warsaw, IN2 decisions2014–20210 recalls

FDA records 2 decisions for Jace Medical, LLC (Warsaw, IN) from 2014 to 2021: 2 510(k) clearances. All are in product code HRS (Plate, Fixation, Bone). Its devices cite 10 predicates, 1 of them its own earlier devices. 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 Jace Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2014: 12021: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Jace Medical, LLC by year, 2014–2026Sources: 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, Bone2decisions

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142484Sternal Closure SystemJace Medical, LLC · 20141cites it

What has FDA decided for it lately?

  • K210290JACE Medical Thoracic Plating SystemJace Medical, LLC · 2021
  • K142484Sternal Closure SystemJace Medical, LLC · 2014

All 2 as Jace Medical, LLC →

Other applicant names beginning “Jace”

FDA records each applicant name separately; these may or may not be the same firm.

Jace Systems, Inc. 6