FDA applicant

Fix Surgical

Conshohocken, PA2 decisions2024–20245 recalls

FDA records 2 decisions for Fix Surgical (Conshohocken, PA) in 2024: 2 510(k) clearances. All are in product code PHX (Shoulder Prosthesis, Reverse Configuration). Its devices cite 4 predicates, 1 of them its own earlier devices. 5 recalls are 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 Fix Surgical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2024high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

5in 2026

2024high 5 (2026) · low 0 (2024)2026

Class I Class II/III not classified

FIG. 1 — Fix Surgical by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Fix Surgical

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?