Cleared Traditional

K122310 - GEMINUS FOSSA SPECIFIC PLATE SYSTEM

K122310 is the FDA 510(k) clearance for GEMINUS FOSSA SPECIFIC PLATE SYSTEM by Skeletal Dynamics, LLC. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K122310 · Skeletal Dynamics, LLC · Orthopedic device
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Jan 2013
Decision
170d
Days
Class 2
Risk

K122310 is an FDA 510(k) clearance for the GEMINUS FOSSA SPECIFIC PLATE SYSTEM. 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 January 18, 2013 after a review of 170 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Skeletal Dynamics, LLC devices

Submission Details

510(k) Number K122310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2012
Decision Date January 18, 2013
Days to Decision 170 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 122d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 886
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K122310.
AAP RADIUS SET 2.5
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INTEGRA TOTAL FOOT SYSTEMS
K123000 · Integra LifeSciences Corporation · Dec 2012
LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG
K121495 · Aap Implantate AG · Dec 2012
LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING
K121494 · Aap Implantate AG · Nov 2012