Cleared Traditional

K120689 - SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM

K120689 is an FDA 510(k) clearance for SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PL..., manufactured by Synthes USA Products, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K120689 · Synthes USA Products, LLC · Orthopedic device
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Jun 2012
Decision
90d
Days
Class 2
Risk

K120689 is an FDA 510(k) clearance for the SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA 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 Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on June 4, 2012 after a review of 90 days - within the typical 510(k) review window.

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 Synthes USA Products, LLC devices

FDA 510(k) Submission Details - K120689

510(k) Number K120689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2012
Decision Date June 04, 2012
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 1254
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K120689.
SYNTHES VA LCP ANKLE TRAUMA SYSTEM
K120854 · Synthes (Usa) · Jun 2012
MINI MAXLOCK EXTREME PLATING SYSTEM
K121437 · Orthohelix Surgical Designs, Inc. · Jun 2012
NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE
K120772 · Zimmer GmbH · Jun 2012
ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS
K120360 · Ortho Solutions Limited · May 2012
EOS SMALL BONE FIXATION SYSTEM
K112794 · TriMed, Inc. · May 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
K120717 · Synthes (Usa) · May 2012