Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head— 510(k) K191708

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K191708 for Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head, Substantially Equivalent on 2020-08-14. Applicant: Signature Orthopaedics Pty, Ltd..

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2019-06-26
Decision date: 2020-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.