Cleared Special

K100197 - GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS

K100197 is an FDA 510(k) clearance for GENESIS UNICONDYLAR UHMWPE ARTICULAR IN..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Special 510(k) pathway after a 28-day FDA review.

K100197 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
28d
Days
Class 2
Risk

K100197 is an FDA 510(k) clearance for the GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on February 19, 2010 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 - K100197

510(k) Number K100197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2010
Decision Date February 19, 2010
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.

HSX Device Classification - Class 2, Special Controls

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 114
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K100197.
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
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TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM
K101206 · Alexandria Research Technologies, LLC · Jul 2010
MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM
K092441 · Conformis, Inc. · Sep 2009
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM
K090024 · Alexandria Research Technologies, LLC · May 2009
MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
K082172 · Mako Surgical Corporation · Nov 2008
K100197 · GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS
Download PDF FDA Summary Smith & Nephew, Inc.