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Journey Unicondylar Tibial Baseplates

by Smith & Nephew, Inc.

510(k) K102069

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 · Traditional NumberK102069 Date5 Oct 2010ClearedStatusActive

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  • Withdrawn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, 24 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 Journey Unicondylar Tibial Baseplates are orthopedic devices used in unicompartmental knee replacement surgery. These tibial baseplates are similar in design features, indications, and materials to the Smith & Nephew Genesis Unicompartmental Tibial Baseplates. They are part of a unicompartmental knee system designed for tissue-conscious implantation.

The device is supplied in various sizes including medial- and lateral-specific tibial baseplates. It has received FDA 510(k) clearance with the K number K102069, determined to be substantially equivalent to predicate devices. The baseplates are manufactured by Smith & Nephew, Inc. and are intended for use in unicompartmental knee arthroplasty procedures.

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Questions

AI-generated answers, 24 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 are the Journey Unicondylar Tibial Baseplates used for?

    The Journey Unicondylar Tibial Baseplates are orthopedic devices specifically designed for unicompartmental knee replacement surgery. They are part of a tissue-conscious unicompartmental knee system used to replace damaged knee compartments while preserving healthy tissue.

  • What sizes and models of the Journey Unicondylar Tibial Baseplates are available?

    These tibial baseplates are supplied in various sizes, including medial- and lateral-specific options to accommodate different anatomical requirements in unicompartmental knee arthroplasty procedures.

  • What is the regulatory status of the Journey Unicondylar Tibial Baseplates?

    The device has received FDA 510(k) clearance with the K number K102069, determined to be substantially equivalent to predicate devices. This clearance indicates it meets the necessary safety and effectiveness requirements for market distribution.

  • Are the Journey Unicondylar Tibial Baseplates single-use or reusable devices?

    The device data does not specify whether these baseplates are single-use or reusable. For proper usage instructions and sterilization protocols, clinicians should refer to the manufacturer's guidelines and product documentation.