Cleared Traditional

K120854 - SYNTHES VA LCP ANKLE TRAUMA SYSTEM

K120854 is the FDA 510(k) clearance for SYNTHES VA LCP ANKLE TRAUMA SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K120854 · Synthes (Usa) · Orthopedic device
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Jun 2012
Decision
89d
Days
Class 2
Risk

K120854 is an FDA 510(k) clearance for the SYNTHES VA LCP ANKLE TRAUMA 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 Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on June 18, 2012 after a review of 89 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 Synthes (Usa) devices

Submission Details

510(k) Number K120854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2012
Decision Date June 18, 2012
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K120854.
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K113652 · Aap Implantate AG · Aug 2012
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
K120903 · Acumed, LLC · Jul 2012
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
K121601 · Synthes (Usa) · Jul 2012
NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE
K120772 · Zimmer GmbH · Jun 2012
SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
K120689 · Synthes USA Products, LLC · Jun 2012
EOS SMALL BONE FIXATION SYSTEM
K112794 · TriMed, Inc. · May 2012