# Subchondral Solutions, Inc.

- Location (FDA's records): Los Gatos, CA
- FDA decisions: 3 (2017–2022): 3 510(k) clearances
- Names in FDA's records: Subchondral Solutions, Inc. (2); Subchondral Solutions (1)
- Product codes: HWC (2), MBI (1)
- 510(k) review time since 2016: median 267 days, against 75 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 4 (3 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
- Acumed, LLC: 2 (https://510kreport.com/company/acumed)
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)

## Firms that cite its devices most
- Auxano Medical, LLC: 1 (https://510kreport.com/company/auxano-medical)

## Its most-cited devices
- K162171: S4 Screw System™ (2017), cited by 2
- K191995: S4 Screw System (2020), cited by 2

## Recent decisions
- K220901: S-Core Implant System (Jul 29, 2022)
- K191995: S4 Screw System (Apr 18, 2020)
- K162171: S4 Screw System™ (Sep 7, 2017)

Source page: https://510kreport.com/company/subchondral-solutions