Skeletal Dynamics
FDA Regulatory Profile
Skeletal Dynamics appears in FDA public data with 1 recall, 39 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0582-2015, Class II) was initiated on October 16, 2014. Its most recent 510(k) clearance was granted on March 23, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 39
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0582-2015 | Class II | Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post | October 16, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254288 | Clavicle Fixation System | March 23, 2026 |
| K252949 | Geminus Volar Distal Radius Plating System | November 13, 2025 |
| K242436 | Proximal Humerus Fixation System | November 14, 2024 |
| K243381 | Total Wrist Arthroplasty System (TWA) | November 1, 2024 |
| K241815 | Protean Fragment Plating System | September 26, 2024 |
| K242055 | Freefix Forearm Plating System | August 1, 2024 |
| K240835 | Suture Button Repair System | July 19, 2024 |
| K233574 | Total Wrist Arthroplasty System (TWA) | July 3, 2024 |
| K231447 | Double Internal Joint Stabilizer- Elbow | December 15, 2023 |
| K231188 | ALIGN Radial Head System | September 28, 2023 |
| K231623 | Distal Elbow Plating System | August 28, 2023 |
| K223318 | Internal Joint Stabilizer - Elbow | May 10, 2023 |
| K230908 | Hand Trauma Threaded Nail System | April 28, 2023 |
| K220723 | Hand Trauma Screw System | May 12, 2022 |
| K213895 | Distal Humerus Plating System | January 13, 2022 |
| K211439 | Small Bone Nailing System | September 30, 2021 |
| K201962 | Skeletal Dynamics Ulnar Shortening Plating System | October 13, 2020 |
| K201662 | REDUCT® Headless Compression Screw System | July 16, 2020 |
| K200538 | Skeletal Dynamics Forearm Plating System | June 1, 2020 |
| K200367 | Distal Humerus Plating System | May 14, 2020 |