Chrysalis Intelligence · Sponsors · Skeletal Dynamics, Inc.

Skeletal Dynamics, Inc.

Miami, FL, US · 22 510(k) clearances

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Total clearances
22
2020-05-14 → 2026-07-29
Last 12 months
3
Product codes
7
Most recent
2026-07-29
Name variants in FDA filings: Skeletal Dynamics, Inc. / Skeletal Dynamics
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HRS Plate, Fixation, Bone Class II Orthopedic 11 2026-03-23
HWC Screw, Fixation, Bone Class II Orthopedic 3 2023-04-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Class II Orthopedic 2 2026-07-29
JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Class II Orthopedic 2 2024-11-01
OZI Internal Hinged Elbow Fixator Class II Orthopedic 2 2023-12-15
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Class II Orthopedic 1 2023-09-28
HTY — — — 1 2021-09-30
Filings

All 510(k) clearances (22)

Date K-number Device Code Class Specialty
2026-07-29 K261770 Suture Button Repair System MBI Class II Orthopedic
2026-03-23 K254288 Clavicle Fixation System HRS Class II Orthopedic
2025-11-13 K252949 Geminus Volar Distal Radius Plating System HRS Class II Orthopedic
2024-11-14 K242436 Proximal Humerus Fixation System HRS Class II Orthopedic
2024-11-01 K243381 Total Wrist Arthroplasty System (TWA) JWJ Class II Orthopedic
2024-09-26 K241815 Protean Fragment Plating System HRS Class II Orthopedic
2024-08-01 K242055 Freefix Forearm Plating System HRS Class II Orthopedic
2024-07-19 K240835 Suture Button Repair System MBI Class II Orthopedic
2024-07-03 K233574 Total Wrist Arthroplasty System (TWA) JWJ Class II Orthopedic
2023-12-15 K231447 Double Internal Joint Stabilizer- Elbow OZI Class II Orthopedic
2023-09-28 K231188 ALIGN Radial Head System KWI Class II Orthopedic
2023-08-28 K231623 Distal Elbow Plating System HRS Class II Orthopedic
2023-05-10 K223318 Internal Joint Stabilizer - Elbow OZI Class II Orthopedic
2023-04-28 K230908 Hand Trauma Threaded Nail System HWC Class II Orthopedic
2022-05-12 K220723 Hand Trauma Screw System HWC Class II Orthopedic
2022-01-13 K213895 Distal Humerus Plating System HRS Class II Orthopedic
2021-09-30 K211439 Small Bone Nailing System HTY — —
2020-10-13 K201962 Skeletal Dynamics Ulnar Shortening Plating System HRS Class II Orthopedic
2020-07-16 K201662 REDUCT® Headless Compression Screw System HWC Class II Orthopedic
2020-06-01 K200538 Skeletal Dynamics Forearm Plating System HRS Class II Orthopedic
2020-05-14 K200701 Skeletal Dynamics Midshaft Humerus Plating System HRS Class II Orthopedic
2020-05-14 K200367 Distal Humerus Plating System HRS Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence