Cleared Traditional

K111620 - SKELETAL DYNAMICS GEMINUS VOLAR DISTAL ...

K111620 is an FDA 510(k) clearance for SKELETAL DYNAMICS GEMINUS VOLAR DISTAL ..., manufactured by Skeletal Dynamics, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K111620 · Skeletal Dynamics, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
74d
Days
Class 2
Risk

K111620 is an FDA 510(k) clearance for the SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIG.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Skeletal Dynamics, LLC (Miami, US). The FDA issued a Cleared decision on August 23, 2011 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Skeletal Dynamics, LLC devices

FDA 510(k) Submission Details - K111620

510(k) Number K111620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2011
Decision Date August 23, 2011
Days to Decision 74 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1042
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K111620.
OSTEOMED HAND FUSION SYSTEM
K111419 · Osteomed LP · Oct 2011
EASYLOCK OSTEOSYSTEM
K111266 · TriMed, Inc. · Oct 2011
AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES
K112455 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Sep 2011
TRIMED RADIOCARPAL FUSION SYSTEM
K102785 · TriMed, Inc. · Aug 2011
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS
K111432 · Wrightmedicaltechnologyinc · Aug 2011
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K111540 · Synthes (Usa) · Aug 2011