# Orthosoft Inc (D/B/A Zimmer Cas)

- Location (FDA's records): Montreal, CA
- FDA decisions: 27 (2017–2026): 27 510(k) clearances
- Names in FDA's records: Orthosoft Inc (D/B/A Zimmer Cas) (14); Orthosoft D/B/A Zimmer Cas (7); Orthosoft Inc. (d/b/a) Zimmer CAS (5); Orthosoft Inc. (D/B/A) Zimmer Cas) (1)
- Product codes: OLO (13), QHE (6), LLZ (4), SBF (2), KWT (1), JWH (1)
- 510(k) review time since 2016: median 95 days, against 91 for FDA's reviews in the same codes and years (12 of 25 faster)
- Predicates its devices cite: 36 (23 its own); citations of its devices by later devices: 30 (23 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
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- Mako Surgical Corp.: 2 (https://510kreport.com/company/mako-surgical)
- Blue Ortho: 1 (https://510kreport.com/company/blue-ortho)
- Jointpoint, Inc.: 1 (https://510kreport.com/company/jointpoint)
- Tornier, Inc.: 1 (https://510kreport.com/company/tornier)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)
- Onefit Medical: 1 (https://510kreport.com/company/onefit-medical)
- Zimmer Cas: 1 (https://510kreport.com/company/zimmer-cas)

## Firms that cite its devices most
- Microport Navibot International, LLC: 1 (https://510kreport.com/company/microport-navibot-international)
- Zebra Medical Vision, Ltd.: 1 (https://510kreport.com/company/zebra-medical-vision)
- THINK Surgical, Inc.: 1 (https://510kreport.com/company/think-surgical)
- Mr Surgical Solutions, LLC: 1 (https://510kreport.com/company/mr-surgical-solutions)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- Balmoral Medical, LLC: 1 (https://510kreport.com/company/balmoral-medical)
- Enhatch, Inc.: 1 (https://510kreport.com/company/enhatch)

## Its most-cited devices
- K182964: ROSA Knee System (2019), cited by 8
- K190595: Signature ONE System (2019), cited by 3
- K233199: ROSA® Shoulder System (2024), cited by 2
- K221928: ROSA® Knee System (2022), cited by 2
- K230243: ROSA® Knee System (2023), cited by 2
- K212560: Signature™ ONE System (2021), cited by 2

## Recent decisions
- K261510: Signature™ ONE System (Jun 4, 2026)
- K260582: ROSA® Shoulder System (May 21, 2026)
- K260104: Signature™ ONE System (Feb 4, 2026)
- K251314: Rosa® Knee System (Nov 13, 2025)
- K242864: ROSA® Knee System (Oct 18, 2024)
- K233199: ROSA® Shoulder System (Feb 21, 2024)
- K232425: Signature™ ONE System (Dec 12, 2023)
- K232533: ROSA Partial Knee System (Nov 16, 2023)

Source page: https://510kreport.com/company/orthosoft-d-b-a-zimmer-cas