Cleared Traditional

SMALL BONE LOCKING PLATING SYSTEM (K081546) - FDA 510(k) Clearance

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

K081546 · DePuy Orthopaedics, Inc. · Orthopedic device
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Aug 2008
Decision
85d
Days
Class 2
Risk

K081546 is an FDA 510(k) clearance for the SMALL BONE LOCKING 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 August 26, 2008 after a review of 85 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 K081546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2008
Decision Date August 26, 2008
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 K081546.
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES
K082078 · Zimmer, Inc. · Nov 2008
CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE
K081374 · Wrightmedicaltechnologyinc · Sep 2008
SYNTHES RIB FIXATION SYSTEM
K081623 · Synthes (Usa) · Sep 2008
SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES
K081353 · Synthes (Usa) · Jul 2008
ORTHOMESH
K073115 · Synthes (Usa) · Jul 2008
EVOLVE EPS SYSTEM
K081373 · Wrightmedicaltechnologyinc · Jul 2008