Cleared Special

K103010 - STRYKER PATIENT SPECIFIC POLYMER IMPLANT

K103010 is an FDA 510(k) clearance for STRYKER PATIENT SPECIFIC POLYMER IMPLANT, manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The device is a Class 2 General & Plastic Surgery device with product code KKY cleared through the Special 510(k) pathway after a 14-day FDA review.

K103010 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
14d
Days
Class 2
Risk

K103010 is an FDA 510(k) clearance for the STRYKER PATIENT SPECIFIC POLYMER IMPLANT. Classified as Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (product code KKY), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on October 26, 2010 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3500 - the FDA general and plastic surgery device 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.

FDA 510(k) Submission Details - K103010

510(k) Number K103010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2010
Decision Date October 26, 2010
Days to Decision 14 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

KKY Device Classification - Class 2, Special Controls

Product Code KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3500
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

All 24
Devices cleared under the same product code (KKY) and FDA review panel - the closest regulatory comparables to K103010.
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OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES
K123908 · Matrix Surgical USA · Jul 2013
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
K111323 · Synthes, Inc. · Nov 2011
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT
K080507 · Ceremed , Inc. · Apr 2008
BONALIVE GRANULES AND BONALIVE PLATES
K071937 · Vivoxid , Ltd. · Oct 2007
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
K043250 · Stryker Leibinger · Apr 2005
K103010 · STRYKER PATIENT SPECIFIC POLYMER IMPLANT
Download PDF FDA Summary Howmedica Osteonics C…