FDA applicant

Catalyst Orthoscience, Inc.

Naples, FL13 decisions2016–20250 recalls

FDA records 13 decisions for Catalyst Orthoscience, Inc. (Naples, FL) from 2016 to 2025: 13 510(k) clearances. Most are in product codes PHX (Shoulder Prosthesis, Reverse Configuration) and KWT (Prosthesis, Shoulder, Non-Constrained…). Since 2016 its 510(k)s took a median of 101 days from receipt to decision, against 143 for FDA’s reviews in the same codes and years. Its devices cite 38 predicates, 15 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Catalyst Orthoscience, LLC”.

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 Catalyst Orthoscience, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016high 2 (2018) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Catalyst Orthoscience, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Catalyst Orthoscience, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Catalyst”

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

Catalyst Research Corp. 9 Catalyst, Inc. 1

Catalyst Orthoscience, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

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?

Other applicant names beginning “Catalyst”