510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Skeletal Dynamics, Inc

Miami, FL, US

SKELETAL DYNAMICS, INC appears in FDA device records in Miami, FL. FDA records list 40 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
40
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 40 510(k) clearances for Skeletal Dynamics, Inc between 2010 and 2026. The busiest year on record is 2024, with 6. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Skeletal Dynamics, Inc, by decision year
YearClearances
20104
20113
20121
20131
20142
20153
20172
20182
20205
20211
20222
20235
20246
20251
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261770Suture Button Repair SystemMBISubstantially Equivalent
K254288Clavicle Fixation SystemHRSSubstantially Equivalent
K252949Geminus Volar Distal Radius Plating SystemHRSSubstantially Equivalent
K242436Proximal Humerus Fixation SystemHRSSubstantially Equivalent
K243381Total Wrist Arthroplasty System (TWA)JWJSubstantially Equivalent
K241815Protean Fragment Plating SystemHRSSubstantially Equivalent
K242055Freefix Forearm Plating SystemHRSSubstantially Equivalent
K240835Suture Button Repair SystemMBISubstantially Equivalent
K233574Total Wrist Arthroplasty System (TWA)JWJSubstantially Equivalent
K231447Double Internal Joint Stabilizer- ElbowOZISubstantially Equivalent
K231188ALIGN Radial Head SystemKWISubstantially Equivalent
K231623Distal Elbow Plating SystemHRSSubstantially Equivalent
K223318Internal Joint Stabilizer - ElbowOZISubstantially Equivalent
K230908Hand Trauma Threaded Nail SystemHWCSubstantially Equivalent
K220723Hand Trauma Screw SystemHWCSubstantially Equivalent
K213895Distal Humerus Plating SystemHRSSubstantially Equivalent
K211439Small Bone Nailing SystemHTYSubstantially Equivalent
K201962Skeletal Dynamics Ulnar Shortening Plating SystemHRSSubstantially Equivalent
K201662REDUCT® Headless Compression Screw SystemHWCSubstantially Equivalent
K200538Skeletal Dynamics Forearm Plating SystemHRSSubstantially Equivalent
K200701Skeletal Dynamics Midshaft Humerus Plating SystemHRSSubstantially Equivalent
K200367Distal Humerus Plating SystemHRSSubstantially Equivalent
K182492Geminus Volar Distal Radius Plate SystemHRSSubstantially Equivalent
K180744Stablyx CMC Arthroplasty Implant SystemKYISubstantially Equivalent
K172688Align Radial Head SystemKWISubstantially Equivalent
K171590Distal Elbow Plating SystemHRSSubstantially Equivalent
K153208Internal Joint Stabilizer - ElbowOZISubstantially Equivalent
K150675Dorsal Spanning PlateHRSSubstantially Equivalent
K143624Headless Compression Screw SystemHWCSubstantially Equivalent
K140892DISTAL ELBOW PLATING SYSTEMHRSSubstantially Equivalent
K140372FRAGMENT PLATE SYSTEMHRSSubstantially Equivalent
K122310GEMINUS FOSSA SPECIFIC PLATE SYSTEMHRSSubstantially Equivalent
K122737GEMINUS FOSSA SPECIFIC PLATE SYSTEMHRSSubstantially Equivalent
K111068STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5KYISubstantially Equivalent
K112672HEADLESS COMPRESSION SCREWHWCSubstantially Equivalent
K111620SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICSHRSSubstantially Equivalent
K102103SKELETAL DYNAMICS STERILIZATION TRAYSKCTSubstantially Equivalent
K092723AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEMHRXSubstantially Equivalent
K092721ALIGN RADIAL HEAD SYSTEMKWISubstantially Equivalent
K092720WRIST ARTHRODESIS NAIL SYSTEMHSBSubstantially Equivalent

Registered establishments

FDA registered establishments for Skeletal Dynamics, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30067424813006742481SKELETAL DYNAMICS, INC7300 N Kendall Drive, Miami, FL 33156 US2026and 7 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0582-2015Align 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-ulnar joint with: Joint destruction and/or subluxation and resistance to conservative treatment. Intended use is also for primary replacement after fracture of the radial head and symptomatic sequelae after radial head resection.Report received where the Align Radial Stem fractured.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain