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

Name: FDA 510(k) clearance K133370
Creator: U.S. Food and Drug Administration
Published: 2014-07-22

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. Device class: 2.

Clearance details

Applicant: Signature Orthopaedics Pty Limited
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2013-11-04
Decision date: 2014-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nsw, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code LPH

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K261624 — Omnifit® 20° Series I Insert +11 more2026-07-10
K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating2026-06-05
K251270 — Taperloc® Complete Hip Stem2026-05-19

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.