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TLC Unicompartmental Knee System

by Signature Orthopaedics Pty Ltd

510(k) K212870

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 NumberK212870 Date16 Jun 2022ClearedStatusActive

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  • Withdrawn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
FDA applicant
Signature Orthopaedics Pty, Ltd.
Device class
Class II
Regulation
21 CFR Part 888.3520
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The TLC Unicompartmental Knee System is an orthopedic device classified under product code HSX. It is a substantially equivalent device cleared via the traditional 510(k) pathway.

The device is manufactured by Signature Orthopaedics Pty, Ltd. and received FDA 510(k) clearance on June 16, 2022, under K number K212870. It is intended for use in orthopedic applications as defined by its classification.

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Questions

AI-generated answers, 6 Oct 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 TLC Unicompartmental Knee System used for?

    The TLC Unicompartmental Knee System is intended for use in orthopedic applications as defined by its classification under product code HSX, specifically for unicompartmental knee replacement procedures.

  • How was the TLC Unicompartmental Knee System cleared for market?

    The device received FDA 510(k) clearance through the traditional pathway on June 16, 2022, under K number K212870, as a substantially equivalent device to a legally marketed predicate.

  • Who manufactures the TLC Unicompartmental Knee System and where is it located?

    The TLC Unicompartmental Knee System is manufactured by Signature Orthopaedics Pty, Ltd., located at 7 Sirius Rd., Lane Cove West, NSW 2066, Australia.