Skeletal Dynamics, Inc.
Medical device manufacturer in Miami, FL.
40510(k) clearances
0PMA approvals
1recalls
Device types
- HRS Plate, Fixation, Bone 19
- HWC Screw, Fixation, Bone 5
- KWI Prosthesis, Elbow, Hemi-, Radial, Polymer 3
- OZI Internal Hinged Elbow Fixator 3
- KYI Prosthesis, Wrist, Carpal Trapezium 2
- JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Meta… 2
- MBI Fastener, Fixation, Nondegradable, Soft… 2
- HSB Rod, Fixation, Intramedullary And Accessories 1
- HRX Arthroscope 1
- KCT Sterilization Wrap Containers, Trays… 1
- HTY Pin, Fixation, Smooth 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261770 | Suture Button Repair SystemMBI · Traditional | 07/29/2026SE |
| K254288 | Clavicle Fixation SystemHRS · Abbreviated | 03/23/2026SE |
| K252949 | Geminus Volar Distal Radius Plating SystemHRS · Traditional | 11/13/2025SE |
| K242436 | Proximal Humerus Fixation SystemHRS · Traditional | 11/14/2024SE |
| K243381 | Total Wrist Arthroplasty System (TWA)JWJ · Special | 11/01/2024SE |
| K241815 | Protean Fragment Plating SystemHRS · Traditional | 09/26/2024SE |
| K242055 | Freefix Forearm Plating SystemHRS · Special | 08/01/2024SE |
| K240835 | Suture Button Repair SystemMBI · Traditional | 07/19/2024SE |
| K233574 | Total Wrist Arthroplasty System (TWA)JWJ · Traditional | 07/03/2024SE |
| K231447 | Double Internal Joint Stabilizer- ElbowOZI · Traditional | 12/15/2023SE |
| K231188 | ALIGN Radial Head SystemKWI · Traditional | 09/28/2023SE |
| K231623 | Distal Elbow Plating SystemHRS · Traditional | 08/28/2023SE |
| K223318 | Internal Joint Stabilizer - ElbowOZI · Traditional | 05/10/2023SE |
| K230908 | Hand Trauma Threaded Nail SystemHWC · Special | 04/28/2023SE |
| K220723 | Hand Trauma Screw SystemHWC · Traditional | 05/12/2022SE |
| K213895 | Distal Humerus Plating SystemHRS · Special | 01/13/2022SE |
| K211439 | Small Bone Nailing SystemHTY · Traditional | 09/30/2021SE |
| K201962 | Skeletal Dynamics Ulnar Shortening Plating SystemHRS · Traditional | 10/13/2020SE |
| K201662 | REDUCT® Headless Compression Screw SystemHWC · Special | 07/16/2020SE |
| K200538 | Skeletal Dynamics Forearm Plating SystemHRS · Traditional | 06/01/2020SE |
| K200701 | Skeletal Dynamics Midshaft Humerus Plating SystemHRS · Traditional | 05/14/2020SE |
| K200367 | Distal Humerus Plating SystemHRS · Traditional | 05/14/2020SE |
| K182492 | Geminus Volar Distal Radius Plate SystemHRS · Special | 10/10/2018SE |
| K180744 | Stablyx CMC Arthroplasty Implant SystemKYI · Special | 04/11/2018SE |
| K172688 | Align Radial Head SystemKWI · Special | 12/22/2017SE |
| K171590 | Distal Elbow Plating SystemHRS · Special | 06/27/2017SE |
| K153208 | Internal Joint Stabilizer - ElbowOZI · Traditional | 12/31/2015SE |
| K150675 | Dorsal Spanning PlateHRS · Traditional | 05/12/2015SE |
| K143624 | Headless Compression Screw SystemHWC · Special | 01/13/2015SE |
| K140892 | Distal Elbow Plating SystemHRS · Traditional | 08/28/2014SE |
| K140372 | Fragment Plate SystemHRS · Traditional | 04/07/2014SE |
| K122310 | Geminus Fossa Specific Plate SystemHRS · Traditional | 01/18/2013SE |
| K122737 | Geminus Fossa Specific Plate SystemHRS · Special | 10/03/2012SE |
| K111068 | Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5KYI · Traditional | 12/30/2011SE |
| K112672 | Headless Compression ScrewHWC · Traditional | 12/13/2011SE |
| K111620 | Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole Right…HRS · Traditional | 08/23/2011SE |
| K102103 | Skeletal Dynamics Sterilization TraysKCT · Traditional | 12/07/2010SE |
| K092723 | Akro Vu Videoscopic Carpal Tunnel Release (VCTR) SystemHRX · Traditional | 10/04/2010SE |
| K092721 | Align Radial Head SystemKWI · Traditional | 08/03/2010SE |
| K092720 | Wrist Arthrodesis Nail SystemHSB · Traditional | 06/29/2010SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0582-2015 Class II | Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for…Report received where the Align Radial Stem fractured. | 10/16/2014Terminated |