Cleared Traditional

K143173 - Stryker CMF MEDPOR Customized Implant

K143173 is the FDA 510(k) clearance for Stryker CMF MEDPOR Customized Implant by Stryker. It is a Class 2 General & Plastic Surgery device (product code FWP) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K143173 · Stryker · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2015
Decision
139d
Days
Class 2
Risk

K143173 is an FDA 510(k) clearance for the Stryker CMF MEDPOR Customized Implant. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on March 23, 2015 after a review of 139 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3550 - 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 devices

Submission Details

510(k) Number K143173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2014
Decision Date March 23, 2015
Days to Decision 139 days
Submission Type Traditional
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
24d slower than avg
Panel avg: 115d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FWP Prosthesis, Chin, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3550
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 - FWP Prosthesis, Chin, Internal

All 10
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K143173.
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K153508 · Stryker · Feb 2016
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K946267 · W.L. Gore & Associates, Inc. · Mar 1995
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K933367 · W.L. Gore & Associates, Inc. · Jul 1994