# Miami Device Solutions, LLC

- Location (FDA's records): Miami, FL
- FDA decisions: 7 (2015–2018): 7 510(k) clearances
- Names in FDA's records: Miami Device Solutions, LLC (6); Miami Device Solutions (1)
- Product codes: HRS (6), HWC (1)
- 510(k) review time since 2016: median 91 days, against 119 for FDA's reviews in the same codes and years (5 of 6 faster)
- Predicates its devices cite: 30 (10 its own); citations of its devices by later devices: 11 (10 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Zimmer, Inc.: 8 (https://510kreport.com/company/zimmer)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)
- Acumed, LLC: 2 (https://510kreport.com/company/acumed)
- Stryker Trauma AG: 2 (https://510kreport.com/company/stryker-trauma)
- Stryker Leibinger GmbH & Co KG: 1 (https://510kreport.com/company/stryker-leibinger)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Howmedica Osteonics Corp.: 1 (https://510kreport.com/company/howmedica-osteonics)

## Firms that cite its devices most
- Biedermann Medtech, Inc.: 1 (https://510kreport.com/company/biedermann-medtech)

## Its most-cited devices
- K161292: Distal Radius Plating System (2016), cited by 4
- K141493: Proximal Humerus Plating System (2015), cited by 3
- K162635: Distal Radius Plating System (2016), cited by 2
- K161058: Cannulated Screw (2016), cited by 1
- K162898: Olecranon Plating System (2017), cited by 1

## Recent decisions
- K182810: Distal Radius Plating System (Dec 10, 2018)
- K172786: MDS Plating System (Dec 8, 2017)
- K162898: Olecranon Plating System (Mar 17, 2017)
- K162635: Distal Radius Plating System (Oct 21, 2016)
- K161292: Distal Radius Plating System (Aug 15, 2016)
- K161058: Cannulated Screw (Jul 29, 2016)
- K141493: Proximal Humerus Plating System (Mar 20, 2015)

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