Cleared Traditional

K103243 - 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM

K103243 is the FDA 510(k) clearance for 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K103243 · Synthes (Usa) · Orthopedic device
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Jan 2011
Decision
81d
Days
Class 2
Risk

K103243 is an FDA 510(k) clearance for the 2.4MM VA-LCP INTERCARPAL FUSION 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 January 21, 2011 after a review of 81 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 K103243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2010
Decision Date January 21, 2011
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 K103243.
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
K110125 · Synthes (Usa) · Apr 2011
AXSOS (TM) LOCKING PLATE SYSTEM
K110476 · Stryker Corp. · Mar 2011
APTUS ULNA PLATES
K103332 · Medartis AG · Jan 2011
CONGRUENT BONE PLATE SYSTEM
K102998 · Acumed, LLC · Jan 2011
POSTERIOR LATERAL PLATES
K103408 · DePuy Orthopaedics, Inc. · Dec 2010
CONTOURS LAPIDUS PLATING SYSTEM
K102201 · Orthofix, Inc. · Dec 2010