Cleared Abbreviated

K061011 - COMPETITOR UNICONDYLAR KNEE TIBIAL BASE...

K061011 is the FDA 510(k) clearance for COMPETITOR UNICONDYLAR KNEE TIBIAL BASE... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HSX) cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K061011 · Smith & Nephew, Inc. · Orthopedic device
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Jul 2006
Decision
90d
Days
Class 2
Risk

K061011 is an FDA 510(k) clearance for the COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE. 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 July 11, 2006 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K061011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2006
Decision Date July 11, 2006
Days to Decision 90 days
Submission Type Abbreviated
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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 99
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K061011.
CONFORMIS METAL BACKED TIBIAL COMPONENT
K072368 · Conformis, Inc. · Sep 2007
CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)
K063432 · Conformis, Inc. · Mar 2007
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
K061779 · Smith & Nephew, Inc. · Aug 2006
MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
K060017 · Mako Surgical Corp. · Feb 2006
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
K043570 · Conformis, Inc. · Mar 2005
EIUS UNICOMPARTMENTAL KNEE SYSTEM
K033769 · Howmedica Osteonics Corp. · Feb 2004