Skeletal Dynamics

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
38
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0582-2015Class IIAlign Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or postOctober 16, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K252949Geminus Volar Distal Radius Plating SystemNovember 13, 2025
K242436Proximal Humerus Fixation SystemNovember 14, 2024
K243381Total Wrist Arthroplasty System (TWA)November 1, 2024
K241815Protean Fragment Plating SystemSeptember 26, 2024
K242055Freefix Forearm Plating SystemAugust 1, 2024
K240835Suture Button Repair SystemJuly 19, 2024
K233574Total Wrist Arthroplasty System (TWA)July 3, 2024
K231447Double Internal Joint Stabilizer- ElbowDecember 15, 2023
K231188ALIGN Radial Head SystemSeptember 28, 2023
K231623Distal Elbow Plating SystemAugust 28, 2023
K223318Internal Joint Stabilizer - ElbowMay 10, 2023
K230908Hand Trauma Threaded Nail SystemApril 28, 2023
K220723Hand Trauma Screw SystemMay 12, 2022
K213895Distal Humerus Plating SystemJanuary 13, 2022
K211439Small Bone Nailing SystemSeptember 30, 2021
K201962Skeletal Dynamics Ulnar Shortening Plating SystemOctober 13, 2020
K201662REDUCT® Headless Compression Screw SystemJuly 16, 2020
K200538Skeletal Dynamics Forearm Plating SystemJune 1, 2020
K200367Distal Humerus Plating SystemMay 14, 2020
K200701Skeletal Dynamics Midshaft Humerus Plating SystemMay 14, 2020