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Competitor Unicondylar Knee Tibial Baseplate

by Smith & Nephew, Inc.

510(k) K061011

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK061011 Date11 Jul 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HSX
Device Class
Class II
Regulation
21 CFR Part 888.3520
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Competitor Unicondylar Knee Tibial Baseplate is a prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer device. It is classified as a Class II device with product code HSX. The device is used for restoring either compartment of a knee affected by noninflammatory degenerative joint disease, correction of functional deformity, or revision procedures.

The Competitor Unicondylar Knee Tibial Baseplate is supplied by Smith & Nephew, Inc. and has received FDA 510K clearance with the k number K061011. The device is intended for use in orthopedic procedures and is made of metal and polymer materials. It is available in specific sizes and configurations, and is regulated as a medical device with special controls.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Competitor Unicondylar Knee Tibial Baseplate used for?

    The Competitor Unicondylar Knee Tibial Baseplate is used for restoring either compartment of a knee affected by noninflammatory degenerative joint disease, correction of functional deformity, or revision procedures, as it is a non-constrained, cemented prosthesis.

  • What materials is the Competitor Unicondylar Knee Tibial Baseplate made of?

    The Competitor Unicondylar Knee Tibial Baseplate is made of metal and polymer materials, which are commonly used in orthopedic implants for their durability and biocompatibility.

  • Is the Competitor Unicondylar Knee Tibial Baseplate available in different sizes?

    Yes, the Competitor Unicondylar Knee Tibial Baseplate is available in specific sizes and configurations to accommodate different patient needs and anatomical requirements.

  • What regulatory clearance has the Competitor Unicondylar Knee Tibial Baseplate received?

    The Competitor Unicondylar Knee Tibial Baseplate has received FDA 510K clearance with the k number K061011, indicating that it has been found to be substantially equivalent to a predicate device.