Cleared Special

K060514 - STRYKER PLATING SYSTEM

K060514 is the FDA 510(k) clearance for STRYKER PLATING SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 18-day FDA review.

K060514 · Howmedica Osteonics Corp. · Orthopedic device
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Mar 2006
Decision
18d
Days
Class 2
Risk

K060514 is an FDA 510(k) clearance for the STRYKER 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 Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on March 17, 2006 after a review of 18 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K060514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2006
Decision Date March 17, 2006
Days to Decision 18 days
Submission Type Special
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
104d faster than avg
Panel avg: 122d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 904
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K060514.
AXSOS PLUS LOCKING PLATE SYSTEM
K061012 · Howmedica Osteonics Corp. · May 2006
POLYAX LOCKED PLATING SYSTEM
K060969 · DePuy Orthopaedics, Inc. · May 2006
STRYKER PLATING SYSTEM
K060798 · Howmedica Osteonics Corp. · Apr 2006
TRIMED BONE PLATES
K060041 · TriMed, Inc. · Feb 2006
ARTHREX TENSIONLOK
K052901 · Arthrex, Inc. · Dec 2005
SYNTHES (USA) STERNAL FIXATION SYSTEM
K052683 · Synthes (Usa) · Dec 2005