FDA applicant

Skeletal Dynamics, Inc.

Miami, FL40 decisions2010–20261 recall

FDA records 40 decisions for Skeletal Dynamics, Inc. (Miami, FL) from 2010 to 2026: 40 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 61 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 59 predicates, 21 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Skeletal Dynamics, LLC”, “Skeletal Dynamics”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Skeletal Dynamics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2010high 6 (2024) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2014

2010high 1 (2014) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Skeletal Dynamics, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Skeletal Dynamics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

HRSPlate, Fixation, Bone19decisions
HWCScrew, Fixation, Bone5decisions
OZIInternal Hinged Elbow Fixator3decisions
KWIProsthesis, Elbow, Hemi-, Radial, Polymer3decisions
JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained2decisions
KYIProsthesis, Wrist, Carpal Trapezium2decisions

Also: MBI (2), KCT (1), HSB (1), HRX (1), HTY (1).

How long do its 510(k) reviews take?

Since 2016, its 21 510(k)s took a median of 61 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 96 days; 14 of its 21 were faster than that.

Whose devices does it build on?

Its devices cite 59 predicates; 21 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 32 times; 21 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

K182492Geminus Volar Distal Radius Plate SystemSkeletal Dynamics, LLC · 20184cite it
K111620Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole Right, Standard 3 Hole Left…Skeletal Dynamics, LLC · 20114cite it
K143624Headless Compression Screw SystemSkeletal Dynamics, LLC · 20153cite it
K122737Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC · 20122cite it
K140892Distal Elbow Plating SystemSkeletal Dynamics, LLC · 20142cite it
K112672Headless Compression ScrewSkeletal Dynamics, LLC · 20112cite it

What has FDA decided for it lately?

K261770Suture Button Repair SystemSkeletal Dynamics, Inc. · 2026
K254288Clavicle Fixation SystemSkeletal Dynamics, Inc. · 2026
K252949Geminus Volar Distal Radius Plating SystemSkeletal Dynamics, Inc. · 2025
K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc. · 2024
K243381Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc. · 2024
K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc. · 2024
K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc. · 2024
K240835Suture Button Repair SystemSkeletal Dynamics, Inc. · 2024

All 21 as Skeletal Dynamics, Inc. →All 18 as Skeletal Dynamics, LLC →The one decision as Skeletal Dynamics →

What has been recalled?

1 recall linked to its devices; the latest:

K092721Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for…Oct 16, 2014Class II

Other applicant names beginning “Skeletal”

FDA records each applicant name separately; these may or may not be the same firm.

Skeletal Kinetics, LLC 10 The Skeletal Design Partnership, Ltd. 1