Austin, TX, US · 16 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | 4 | 2026-01-15 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 4 | 2025-12-19 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | 3 | 2023-06-23 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | 2 | 2025-11-12 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | 1 | 2025-02-07 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | 1 | 2021-03-30 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Class II | Orthopedic | 1 | 2020-06-03 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-15 | K252567 | AltiVate Reverse® ADLC Glenosphere | PHX | Class II | Orthopedic |
| 2025-12-19 | K252974 | EMPOWR Knee | JWH | Class II | Orthopedic |
| 2025-11-12 | K251833 | EMPOWR Acetabular® Liner Extension | LPH | Class II | Orthopedic |
| 2025-08-05 | K252141 | AltiVate Reverse® Glenoid | PHX | Class II | Orthopedic |
| 2025-07-08 | K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) | JWH | Class II | Orthopedic |
| 2025-07-02 | K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | JWH | Class II | Orthopedic |
| 2025-05-16 | K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System | PHX | Class II | Orthopedic |
| 2025-02-07 | K241483 | ceramys femoral head system | LZO | Class II | Orthopedic |
| 2024-05-29 | K233481 | AltiVate Reverse® Glenoid | PHX | Class II | Orthopedic |
| 2023-06-23 | K222592 | AltiVate® Anatomic Shoulder AG e+ with Markers | KWS | Class II | Orthopedic |
| 2022-07-07 | K213387 | AltiVate® Anatomic Shoulder AG e+ with Markers | KWS | Class II | Orthopedic |
| 2022-04-01 | K213793 | EMPOWR Revision Knee | JWH | Class II | Orthopedic |
| 2021-03-30 | K210308 | EMPOWR Porous Femur with HAnano SurfaceTM | MBH | Class II | Orthopedic |
| 2021-02-10 | K203557 | EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing | LPH | Class II | Orthopedic |
| 2020-12-23 | K203026 | AltiVate® Anatomic Pegged Glenoid with Markers | KWS | Class II | Orthopedic |
| 2020-06-03 | K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | PKC | Class II | Orthopedic |