Cleared Traditional

K060969 - POLYAX LOCKED PLATING SYSTEM

K060969 is an FDA 510(k) clearance for POLYAX LOCKED PLATING SYSTEM, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K060969 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
35d
Days
Class 2
Risk

K060969 is an FDA 510(k) clearance for the POLYAX LOCKED 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 May 12, 2006 after a review of 35 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

FDA 510(k) Submission Details - K060969

510(k) Number K060969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2006
Decision Date May 12, 2006
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
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 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K060969.
AXSOS PLUS LOCKING PLATE SYSTEM
K061012 · Howmedica Osteonics Corp. · May 2006
TTC PLATE
K060473 · New Deal, S.A. · May 2006
LAPIDUS PLATE
K060476 · New Deal, S.A. · May 2006
STRYKER PLATING SYSTEM
K060798 · Howmedica Osteonics Corp. · Apr 2006
STRYKER PLATING SYSTEM
K060514 · Howmedica Osteonics Corp. · Mar 2006
DRLOCK DISTAL RADIUS VOLAR SYSTEM
K053182 · Orthohelix Surgical Designs, Inc. · Feb 2006