Data / Medical devices / United States / Skeletal Dynamics, Inc

Skeletal Dynamics, Inc: FDA-registered device maker in Miami, FL, United States, 36 510(k) clearances

Name: Skeletal Dynamics, Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Skeletal Dynamics, Inc is registered with the FDA (registration 3006742481) in Miami, FL, United States. It lists 17 device types. The FDA files 36 510(k) clearances under its listings, the newest dated March 23, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006742481
Address: 7300 N Kendall Drive Suite 800, Miami, FL, United States, 33156
Owner or operator: Skeletal Dynamics, Inc (10034431)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: December 1, 2010
Registered through: 2026
Brand names listed: ALIGN Radial Head System, Align Radial Head, Clavicle Fixation System, Distal Elbow Plating System, Distal Humerus Plating System, Distal Humerus Plating system, FREEFIX Ulnar Shortening System, FreeFix Foream Plating System and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	LXT	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Bit, Drill	HTW	1	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Cutter, Wire	HXZ	1	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Instruments Designed For Press-Fit Osteochondral Implants	QBO	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Internal Hinged Elbow Fixator	OZI	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Prosthesis, Elbow, Hemi-, Radial, Polymer	KWI	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained	JWJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Wrist, Carpal Trapezium	KYI	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Screwdriver	HXX	1	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 23, 2026	K254288	Clavicle Fixation System	HRS	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
November 13, 2025	K252949	Geminus Volar Distal Radius Plating System	HRS	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
November 14, 2024	K242436	Proximal Humerus Fixation System	HRS	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
September 26, 2024	K241815	Protean Fragment Plating System	HRS	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
August 1, 2024	K242055	Freefix Forearm Plating System	HRS	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
July 19, 2024	K240835	Suture Button Repair System	MBI	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
July 3, 2024	K233574	Total Wrist Arthroplasty System (TWA)	JWJ	Substantially Equivalent	Skeletal Dynamics	accessdata.fda.gov
December 15, 2023	K231447	Double Internal Joint Stabilizer- Elbow	OZI	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
September 28, 2023	K231188	ALIGN Radial Head System	KWI	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
August 28, 2023	K231623	Distal Elbow Plating System	HRS	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
May 10, 2023	K223318	Internal Joint Stabilizer - Elbow	OZI	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
April 28, 2023	K230908	Hand Trauma Threaded Nail System	HWC	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
May 12, 2022	K220723	Hand Trauma Screw System	HWC	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
January 13, 2022	K213895	Distal Humerus Plating System	HRS	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
September 30, 2021	K211439	Small Bone Nailing System	HTY	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
October 13, 2020	K201962	Skeletal Dynamics Ulnar Shortening Plating System	HRS	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
July 16, 2020	K201662	REDUCT® Headless Compression Screw System	HWC	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
June 1, 2020	K200538	Skeletal Dynamics Forearm Plating System	HRS	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
May 14, 2020	K200701	Skeletal Dynamics Midshaft Humerus Plating System	HRS	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
May 14, 2020	K200367	Distal Humerus Plating System	HRS	Substantially Equivalent	Skeletal Dynamics, Inc.	accessdata.fda.gov
October 10, 2018	K182492	Geminus Volar Distal Radius Plate System	HRS	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
April 11, 2018	K180744	Stablyx CMC Arthroplasty Implant System	KYI	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
December 22, 2017	K172688	Align Radial Head System	KWI	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
June 27, 2017	K171590	Distal Elbow Plating System	HRS	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
December 31, 2015	K153208	Internal Joint Stabilizer - Elbow	OZI	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
May 12, 2015	K150675	Dorsal Spanning Plate	HRS	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
January 13, 2015	K143624	Headless Compression Screw System	HWC	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
August 28, 2014	K140892	DISTAL ELBOW PLATING SYSTEM	HRS	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
April 7, 2014	K140372	FRAGMENT PLATE SYSTEM	HRS	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
January 18, 2013	K122310	GEMINUS FOSSA SPECIFIC PLATE SYSTEM	HRS	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
October 3, 2012	K122737	GEMINUS FOSSA SPECIFIC PLATE SYSTEM	HRS	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
December 30, 2011	K111068	STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5	KYI	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
August 23, 2011	K111620	SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS	HRS	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
December 7, 2010	K102103	SKELETAL DYNAMICS STERILIZATION TRAYS	KCT	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
August 3, 2010	K092721	ALIGN RADIAL HEAD SYSTEM	KWI	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov
June 29, 2010	K092720	WRIST ARTHRODESIS NAIL SYSTEM	HSB	Substantially Equivalent	Skeletal Dynamics, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 16, 2014	69580	Class II	Terminated	Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-uln	Report received where the Align Radial Stem fractured.	accessdata.fda.gov

Compare with other makers

Updated March 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.