# Skeletal Dynamics, Inc.

- Location (FDA's records): Miami, FL
- FDA decisions: 40 (2010–2026): 40 510(k) clearances
- Names in FDA's records: Skeletal Dynamics, Inc. (21); Skeletal Dynamics, LLC (18); Skeletal Dynamics (1)
- Product codes: HRS (19), HWC (5), OZI (3), KWI (3), JWJ (2), KYI (2), MBI (2), KCT (1), HSB (1), HRX (1), HTY (1)
- 510(k) review time since 2016: median 61 days, against 96 for FDA's reviews in the same codes and years (14 of 21 faster)
- Predicates its devices cite: 59 (21 its own); citations of its devices by later devices: 32 (21 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
- Synthes (Usa): 8 (https://510kreport.com/company/synthes-usa)
- DePuy Orthopaedics, Inc.: 4 (https://510kreport.com/company/depuy-orthopaedics)
- Hand Innovations, Inc.: 2 (https://510kreport.com/company/hand-innovations)
- Medartis AG: 2 (https://510kreport.com/company/medartis)
- Acumed, LLC: 2 (https://510kreport.com/company/acumed)
- Biomet, Inc.: 2 (https://510kreport.com/company/biomet)
- Synthes (USA) Products, LLC: 2 (https://510kreport.com/company/synthes-usa-products)
- Tyber Medical, LLC: 1 (https://510kreport.com/company/tyber-medical)

## Firms that cite its devices most
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Orthopaedic Implant Company: 2 (https://510kreport.com/company/orthopaedic-implant)
- Newclip Technics: 2 (https://510kreport.com/company/newclip-technics)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)
- Ensemble Orthopedics, LLC: 1 (https://510kreport.com/company/ensemble-orthopedics)
- Tyber Medical, LLC: 1 (https://510kreport.com/company/tyber-medical)
- Treace Medical Concepts, Inc.: 1 (https://510kreport.com/company/treace-medical-concepts)
- Synthes (USA) Products, LLC: 1 (https://510kreport.com/company/synthes-usa-products)

## Its most-cited devices
- K182492: Geminus Volar Distal Radius Plate System (2018), cited by 4
- K111620: Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole Right, Standard 3 Hole Left, Skeletal Dynamics (2011), cited by 4
- K143624: Headless Compression Screw System (2015), cited by 3
- K122737: Geminus Fossa Specific Plate System (2012), cited by 2
- K140892: Distal Elbow Plating System (2014), cited by 2
- K112672: Headless Compression Screw (2011), cited by 2

## Recent decisions
- K261770: Suture Button Repair System (Jul 29, 2026)
- K254288: Clavicle Fixation System (Mar 23, 2026)
- K252949: Geminus Volar Distal Radius Plating System (Nov 13, 2025)
- K242436: Proximal Humerus Fixation System (Nov 14, 2024)
- K243381: Total Wrist Arthroplasty System (TWA) (Nov 1, 2024)
- K241815: Protean Fragment Plating System (Sep 26, 2024)
- K242055: Freefix Forearm Plating System (Aug 1, 2024)
- K240835: Suture Button Repair System (Jul 19, 2024)

Source page: https://510kreport.com/company/skeletal-dynamics