Cleared Traditional

K100776 - SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM

K100776 is an FDA 510(k) clearance for SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LC..., 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 138-day FDA review.

K100776 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
138d
Days
Class 2
Risk

K100776 is an FDA 510(k) clearance for the SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT 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 August 3, 2010 after a review of 138 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 - K100776

510(k) Number K100776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2010
Decision Date August 03, 2010
Days to Decision 138 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
16d slower than avg
Panel avg: 122d · This submission: 138d
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 K100776.
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
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
ASCENSION ANKLE FUSION PLATE SYSTEM
K100176 · Ascension Orthopedics, Inc. · Jun 2010