Restoration® Modular Hip System— 510(k) K212187
Substantially EquivalentHowmedica Osteonics Corp., Dba Stryker Orthopaedics
FDA 510(k) clearance K212187 for Restoration® Modular Hip System, Substantially Equivalent on 2022-03-01. Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Product code
- Code LPH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Recent devices under product code LPH
view allMore clearances from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
view all- K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System
- K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
- K252898 — Triathlon® Tritanium® Asymmetric Patella +5 more
- K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components
- K250989 — Stryker and Serf hip devices
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, through . 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.