Cleared Traditional

K101536 - 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM

K101536 is an FDA 510(k) clearance for 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLAT..., manufactured by Synthes (Usa), LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K101536 · Synthes (Usa), LLC · Orthopedic device
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Sep 2010
Decision
104d
Days
Class 2
Risk

K101536 is an FDA 510(k) clearance for the 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE 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), LLC (West Chester, US). The FDA issued a Cleared decision on September 15, 2010 after a review of 104 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), LLC devices

FDA 510(k) Submission Details - K101536

510(k) Number K101536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2010
Decision Date September 15, 2010
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
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 1215
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K101536.
ACUMED WRIST ARTHRODESIS PLATE SYSTEM
K100123 · Acumed, LLC · Oct 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
K102156 · Orthohelix Surgical Designs, Inc. · Sep 2010
MINI MAXLOCK EXTREME PLATING SYSTEM
K101962 · Orthohelix Surgical Designs, Inc. · Sep 2010
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
K100776 · Synthes (Usa) · Aug 2010
ASCENSION TOTAL PLATE SYSTEM
K100502 · Ascension Orthopedics, Inc. · Aug 2010
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22
K101240 · DePuy Orthopaedics, Inc. · Jul 2010