# Catalyst Orthoscience, Inc.

- Location (FDA's records): Naples, FL
- FDA decisions: 13 (2016–2025): 13 510(k) clearances
- Names in FDA's records: Catalyst Orthoscience, Inc. (12); Catalyst Orthoscience, LLC (1)
- Product codes: PHX (6), KWT (5), KWS (2)
- 510(k) review time since 2016: median 101 days, against 143 for FDA's reviews in the same codes and years (5 of 10 faster)
- Predicates its devices cite: 38 (15 its own); citations of its devices by later devices: 17 (15 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Encore Medical L.P.: 5 (https://510kreport.com/company/encore-medical)
- DePuy Orthopaedics, Inc.: 4 (https://510kreport.com/company/depuy-orthopaedics)
- Tornier, Inc.: 3 (https://510kreport.com/company/tornier)
- Exactech, Inc.: 3 (https://510kreport.com/company/exactech)
- Biomet, Inc.: 2 (https://510kreport.com/company/biomet)
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)
- Std Mfg., Inc.: 1 (https://510kreport.com/company/std-mfg)
- Arthrosurface, Inc.: 1 (https://510kreport.com/company/arthrosurface)

## Firms that cite its devices most
- Depuy Ireland UC: 1 (https://510kreport.com/company/depuy-ireland-uc)
- Arthrosurface, Inc.: 1 (https://510kreport.com/company/arthrosurface)

## Its most-cited devices
- K152825: Catalyst CSR Shoulder System (2016), cited by 4
- K202611: Catalyst OrthoScience R1 Reverse Shoulder System (2021), cited by 4
- K211991: Catalyst R1 Reverse Shoulder System (2021), cited by 2
- K213349: Catalyst R1 Reverse Shoulder System (2022), cited by 2
- K173812: Catalyst CSR 3 Peg Glenoids (2018), cited by 1
- K182500: Catalyst CSR Press-Fit Humeral Components (2019), cited by 1

## Recent decisions
- K252418: Catalyst F1x Shoulder System (Nov 6, 2025)
- K234105: Catalyst F1x Shoulder System (Apr 5, 2024)
- K232583: Catalyst R1 Reverse Shoulder System (Sep 20, 2023)
- K223655: Catalyst R1 Reverse Shoulder System (May 9, 2023)
- K222317: Catalyst EA Convertible Stemmed Shoulder (Nov 10, 2022)
- K213349: Catalyst R1 Reverse Shoulder System (Jun 23, 2022)
- K211991: Catalyst R1 Reverse Shoulder System (Jul 28, 2021)
- K202611: Catalyst OrthoScience R1 Reverse Shoulder System (Feb 12, 2021)

Source page: https://510kreport.com/company/catalyst-orthoscience