TLC Unicompartmental Knee System

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

Signature Orthopaedics Pty Ltd.

The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Tlc Unicompartmental Knee System.

Pre-market Notification Details

• Device ID: K212870
• 510k Number: K212870
• Device Name: TLC Unicompartmental Knee System
• Classification: Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
• Applicant: Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove, AU 2066
• Contact: Declan Brazil
• Correspondent: Declan Brazil; Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove, AU 2066
• Product Code: HSX
• CFR Regulation Number: 888.3520 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-09
• Decision Date: 2022-06-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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