Cleared Traditional

K111540 - SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM

K111540 is the FDA 510(k) clearance for SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K111540 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
67d
Days
Class 2
Risk

K111540 is an FDA 510(k) clearance for the SYNTHES 3.5MM LCP 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) (West Chester, US). The FDA issued a Cleared decision on August 8, 2011 after a review of 67 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 K111540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2011
Decision Date August 08, 2011
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
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 K111540.
EASYLOCK OSTEOSYSTEM
K111266 · TriMed, Inc. · Oct 2011
TRIMED RADIOCARPAL FUSION SYSTEM
K102785 · TriMed, Inc. · Aug 2011
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS
K111432 · Wrightmedicaltechnologyinc · Aug 2011
ORTHOPEDIATRICS BLADE PLATE SYSTEM
K110959 · OrthoPediatrics Corp. · Aug 2011
ARTHREX DISTAL EXTREMITY PLATE SYSTEM
K111253 · Arthrex, Inc. · Aug 2011
MAESTRO WRIST PLATING SYSTEM
K110271 · Biomet Manufacturing Corp · Jul 2011