REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE— 510(k) K133370

Substantially Equivalent

Signature Orthopaedics Pty Limited

FDA 510(k) clearance K133370 for REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE, Substantially Equivalent on 2014-07-22. Applicant: Signature Orthopaedics Pty Limited.

Clearance details

Applicant: Signature Orthopaedics Pty Limited
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2013-11-04
Decision date: 2014-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nsw, AU

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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.