510(k) Report

FDA applicant

Ingen Orthopedics, LLC

Cranbury, NJ3 decisions2012–20130 recalls

FDA records 3 decisions for Ingen Orthopedics, LLC (Cranbury, NJ) from 2012 to 2013: 3 510(k) clearances. Most are in product codes KWS (Prosthesis, Shoulder, Semi-Constrained…) and HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic…). 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 Ingen Orthopedics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2012: 12013: 2
2012high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Ingen Orthopedics, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1decision
  • HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1decision
  • PHXShoulder Prosthesis, Reverse Configuration1decision

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.

  • K120374Seviin Reverse ShoulderIngen Orthopedics, LLC · 20121cites it

What has FDA decided for it lately?

  • K131277Seviin Fracture ShoulderIngen Orthopedics, LLC · 2013
  • K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC · 2013
  • K120374Seviin Reverse ShoulderIngen Orthopedics, LLC · 2012

All 3 as Ingen Orthopedics, LLC →