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FDA 510(k)

TLC Unicompartmental Knee System

K-Number: K212870 · 2022-06-16

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2022-06-16
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TLC Unicompartmental Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K212870. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TLC Unicompartmental Knee System?

TLC Unicompartmental Knee System is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K212870.

When did TLC Unicompartmental Knee System receive FDA 510(k) clearance?

TLC Unicompartmental Knee System received FDA 510(k) clearance on 2022-06-16, under 510(k) number K212870.

Who is the listed applicant for TLC Unicompartmental Knee System?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TLC Unicompartmental Knee System?

The FDA product code for TLC Unicompartmental Knee System is HSX.

Other records listing Signature Orthopaedics Pty, Ltd. as applicant

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Related Devices (Code: HSX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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