Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Mahwah, NJ, US
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics appears in FDA device records in Mahwah, NJ. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics between 2016 and 2023. The busiest year on record is 2019, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233261 | Global Modular Replacement System | JDI | Substantially Equivalent | |
| K210893 | Restoration Anatomic Shell | LPH | Substantially Equivalent | |
| K203099 | Triathlon PKR System | HSX | Substantially Equivalent | |
| K193233 | Restoration® Modular Hip System | LPH | Substantially Equivalent | |
| K191358 | Trident II Acetabular System | LPH | Substantially Equivalent | |
| K190991 | Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment | MBH | Substantially Equivalent | |
| K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System | LPH | Substantially Equivalent | |
| K180612 | Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts | HSX | Substantially Equivalent | |
| K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components | MBH | Substantially Equivalent | |
| K171768 | Trident® II Acetabular System | LPH | Substantially Equivalent | |
| K161569 | Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws | LPH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain