TLC Unicompartmental Knee System— 510(k) K212870

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K212870 for TLC Unicompartmental Knee System, Substantially Equivalent on 2022-06-16. Applicant: Signature Orthopaedics Pty, Ltd..

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: Code HSX
Advisory panel: Orthopedic
Date received: 2021-09-09
Decision date: 2022-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.