Cleared Special

K163311 - GMK Revision Femoral Distal Augmentation

K163311 is an FDA 510(k) clearance for GMK Revision Femoral Distal Augmentation, manufactured by Medacta International S.A.. The device is a Class 2 Orthopedic device with product code KRO cleared through the Special 510(k) pathway after a 28-day FDA review.

K163311 · Medacta International S.A. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
28d
Days
Class 2
Risk

K163311 is an FDA 510(k) clearance for the GMK Revision Femoral Distal Augmentation. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on December 21, 2016 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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.

FDA 510(k) Submission Details - K163311

510(k) Number K163311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2016
Decision Date December 21, 2016
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

KRO Device Classification - Class 2, Special Controls

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 Consultant

Mapi USA, Inc.
Elizabeth Rose

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 86
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K163311.
Attune Revision LPS Inserts
K191779 · Depuy(Ireland) · Oct 2019
USTAR II System
K190100 · United Orthopedic Corporation · Sep 2019
GMK Hinge, GMK Revision
K172347 · Medacta International S.A. · Nov 2017
ELEOS Limb Salvage System
K161520 · Onkos Surgical, Inc. · Oct 2016
LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating
K152431 · Waldemar Link GmbH & Co. KG · May 2016
LINK® MEGASYSTEM-C®
K151008 · Waldemar Link GmbH & Co. KG · Aug 2015
K163311 · GMK Revision Femoral Distal Augmentation
Download PDF FDA Summary Medacta International…