Stryker Orthopaedics
FDA Regulatory Profile
Stryker Orthopaedics appears in FDA public data with 6 recalls, 24 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1915-2024, Class II) was initiated on April 15, 2024. Its most recent 510(k) clearance was granted on August 16, 2021.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 24
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1915-2024 | Class II | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3 | April 15, 2024 |
| Z-1914-2024 | Class II | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3 | April 15, 2024 |
| Z-1911-2024 | Class II | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3 | April 15, 2024 |
| Z-1912-2024 | Class II | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3 | April 15, 2024 |
| Z-1910-2024 | Class II | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3 | April 15, 2024 |
| Z-1913-2024 | Class II | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3 | April 15, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211703 | Insignia Hip Stem | August 16, 2021 |
| K191414 | EXETER Centralizer, EXETER 2.5mm Plug | August 28, 2019 |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | March 19, 2018 |
| K173849 | Triathlon Total Knee System | February 2, 2018 |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | October 30, 2017 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | May 25, 2016 |
| K151264 | Restoration Anatomic Shell | August 10, 2015 |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Dir | February 9, 2015 |
| K143393 | Triathlon Tritanium Cone Augments | January 13, 2015 |
| K142462 | Restoration Anatomic Shell | November 14, 2014 |
| K141056 | TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS | August 5, 2014 |
| K132624 | TRIATHLON TRITANIUM METAL-BACKED PATELLA | November 26, 2013 |
| K072575 | TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE | January 7, 2008 |
| K070170 | DALL-MILES SYSTEM | March 2, 2007 |
| K063816 | PCA ALUMINA FEMORAL HEADS | February 2, 2007 |
| K063822 | MODIFICATION TO HIPSTAR FEMORAL STEM | January 25, 2007 |
| K062553 | SIMPLEX P BONE CEMENT | January 8, 2007 |
| K051223 | HIPSTAR FEMORAL STEM | May 10, 2006 |
| K053514 | TRIATHLON TOTAL KNEE SYSTEM | January 26, 2006 |
| K053528 | SHORT CITATION FEMORAL STEM | January 13, 2006 |