Cleared Traditional

LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM (K083843) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083843 · DePuy Orthopaedics, Inc. · Orthopedic device
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Mar 2009
Decision
86d
Days
Class 2
Risk

K083843 is an FDA 510(k) clearance for the LOCKING ANATOMIC & COMPOSITE PLATING 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 DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 20, 2009 after a review of 86 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 DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K083843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2008
Decision Date March 20, 2009
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 699
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K083843.
ORTHOLOC 2.0/2.4 PLATE SYSTEM
K090692 · Wrightmedicaltechnologyinc · May 2009
SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM
K090047 · Synthes (Usa) · Apr 2009
1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS
K090492 · DePuy Orthopaedics, Inc. · Mar 2009
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
K083694 · Synthes (Usa) · Mar 2009
SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES
K083573 · Synthes (Usa) · Mar 2009
ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)
K083654 · Zimmer, Inc. · Feb 2009