# Hand Innovations, Inc.

- Location (FDA's records): Miami Lakes, FL
- FDA decisions: 17 (2000–2006): 17 510(k) clearances
- Names in FDA's records: Hand Innovations, Inc. (10); Hand Innovations, LLC (7)
- Product codes: LXT (6), HRS (6), HTY (3), KTT (2)
- Predicates its devices cite: 17 (12 its own); citations of its devices by later devices: 53 (12 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medcanica, Inc.: 2 (https://510kreport.com/company/medcanica)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Synthes: 1 (https://510kreport.com/company/synthes)
- Howmedica Osteonics Corp.: 1 (https://510kreport.com/company/howmedica-osteonics)

## Firms that cite its devices most
- DePuy Orthopaedics, Inc.: 8 (https://510kreport.com/company/depuy-orthopaedics)
- Medartis AG: 4 (https://510kreport.com/company/medartis)
- Biomet, Inc.: 4 (https://510kreport.com/company/biomet)
- Exactech, Inc.: 3 (https://510kreport.com/company/exactech)
- Skeletal Dynamics, Inc.: 2 (https://510kreport.com/company/skeletal-dynamics)
- I.T.S. GmbH: 2 (https://510kreport.com/company/its)
- Smith & Nephew, Inc.: 2 (https://510kreport.com/company/smith-nephew)
- Newclip Technics: 2 (https://510kreport.com/company/newclip-technics)

## Its most-cited devices
- K002775: Distal Volar Radius Fracture Repair System (2000), cited by 8
- K061748: Fragment Plate System (2006), cited by 7
- K050932: Distal Volar Radius Anatomical Plate System (2005), cited by 6
- K023007: Distal Radius Fracture Repair System (2002), cited by 4
- K030198: Hand Innovations, Inc. Distal Radius Fracture Repair System (2003), cited by 4
- K051728: Modification to Shoulder Fixation System (2005), cited by 4

## Recent decisions
- K061748: Fragment Plate System (Jul 17, 2006)
- K060864: Multidirectional Threaded Peg (Apr 28, 2006)
- K060294: Diaphyseal Plate (Mar 22, 2006)
- K060290: Shoulder Fixation System (Feb 27, 2006)
- K052294: Shoulder Nail Plate (Oct 21, 2005)
- K052248: Dorsal Nail Plate, Anatomical (Sep 14, 2005)
- K051728: Modification to Shoulder Fixation System (Jul 20, 2005)
- K050932: Distal Volar Radius Anatomical Plate System (Apr 26, 2005)

Source page: https://510kreport.com/company/hand-innovations