Cleared Traditional

K073186 - SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM

K073186 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 34-day FDA review.

K073186 · Synthes (Usa) · Orthopedic device
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Dec 2007
Decision
34d
Days
Class 2
Risk

K073186 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 December 17, 2007 after a review of 34 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 K073186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2007
Decision Date December 17, 2007
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
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 K073186.
CHARLOTTE CLAW 3.5
K080295 · Wrightmedicaltechnologyinc · Feb 2008
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K073460 · Synthes (Usa) · Feb 2008
BIOFOAM BONE WEDGE
K073535 · Wrightmedicaltechnologyinc · Jan 2008
ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
K072832 · DePuy Orthopaedics, Inc. · Dec 2007
PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS
K072818 · Smith & Nephew, Inc. · Nov 2007
4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.
K072423 · DePuy Orthopaedics, Inc. · Nov 2007