Cleared Traditional

K043250 - STRYKER PATIENT SPECIFIC POLYMER IMPLANT

K043250 is an FDA 510(k) clearance for STRYKER PATIENT SPECIFIC POLYMER IMPLANT, manufactured by Stryker Leibinger. The device is a Class 2 General & Plastic Surgery device with product code KKY cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K043250 · Stryker Leibinger · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
143d
Days
Class 2
Risk

K043250 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 Stryker Leibinger (Kalamazoo, US). The FDA issued a Cleared decision on April 15, 2005 after a review of 143 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Leibinger devices

FDA 510(k) Submission Details - K043250

510(k) Number K043250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2004
Decision Date April 15, 2005
Days to Decision 143 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 115d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 10
Devices cleared under the same product code (KKY) and FDA review panel - the closest regulatory comparables to K043250.
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
K111323 · Synthes, Inc. · Nov 2011
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
K103010 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Oct 2010
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT
K080507 · Ceremed , Inc. · Apr 2008
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR
K043133 · Ceremed , Inc. · Mar 2005
HTR POLYMER, HTR-MX
K904111 · United States Surgical, A Division of Tyco Healthc · Nov 1990
UHMWPE SURGICAL MESH
K894478 · Biomet, Inc. · Mar 1990