Cemented TSI Hip Stem— 510(k) K181340

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K181340 for Cemented TSI Hip Stem, Substantially Equivalent on 2019-02-11. Applicant: Signature Orthopaedics Pty, Ltd..

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 2018-05-21
Decision date: 2019-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.