Cleared Traditional

K110125 - 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM

K110125 is an FDA 510(k) clearance for 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS S..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K110125 · Synthes (Usa) · Orthopedic device
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Apr 2011
Decision
93d
Days
Class 2
Risk

K110125 is an FDA 510(k) clearance for the 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS 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 April 21, 2011 after a review of 93 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) devices

FDA 510(k) Submission Details - K110125

510(k) Number K110125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2011
Decision Date April 21, 2011
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
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 1222
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K110125.
MINI VARIABLE SYSTEM
K111041 · Orthohelix Surgical Designs, Inc. · Jun 2011
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
K111039 · Zimmer, Inc. · May 2011
BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
K110574 · Biomet Microfixation, Inc. · May 2011
AXSOS (TM) LOCKING PLATE SYSTEM
K110476 · Stryker Corp. · Mar 2011
AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS
K110176 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Feb 2011
APTUS ULNA PLATES
K103332 · Medartis AG · Jan 2011