Cleared Special

K103170 - GMK REVISION KNEE SC LINERS

K103170 is an FDA 510(k) clearance for GMK REVISION KNEE SC LINERS, manufactured by Medacta International S.A.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Special 510(k) pathway after a 148-day FDA review.

K103170 · Medacta International S.A. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
148d
Days
Class 2
Risk

K103170 is an FDA 510(k) clearance for the GMK REVISION KNEE SC LINERS. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Medacta International S.A. (San Diego, US). The FDA issued a Cleared decision on March 24, 2011 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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. Standard predicate reliance. 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 - K103170

510(k) Number K103170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2010
Decision Date March 24, 2011
Days to Decision 148 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
26d slower than avg
Panel avg: 122d · This submission: 148d
Pathway characteristics
Modification to existing cleared device.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 921
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K103170.
REVISION PROTHESIS
K110837 · Smith & Nephew, Inc. · Apr 2011
OPTERTRAK LOGIC PSC TIBIAL INSERT
K110547 · Exactech Sarasota · Apr 2011
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K102578 · Omni Life Science, Inc. · Mar 2011
BALANCED KNEE SYSTEM REVISION OFFSET TIBIA
K103837 · Ortho Development · Mar 2011
SYMMETRIC TOTAL KNEE AGUMENTS
K100370 · Signal Medical Corp. · Mar 2011
VANGUARD REMOVABLE MOLDED POLY TIBIA
K102580 · Biomet Manufacturing Corp · Mar 2011
K103170 · GMK REVISION KNEE SC LINERS
Download PDF FDA Summary Medacta International…