Norderstedt, DE · 21 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | 5 | 2026-07-06 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | 3 | 2024-11-08 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | 3 | 2023-11-16 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 3 | 2023-03-21 |
| KRO | — | — | — | 2 | 2022-05-03 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | 2 | 2020-07-17 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | 1 | 2025-11-05 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | 1 | 2022-07-20 |
| KWT | — | — | — | 1 | 2021-06-21 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-06 | K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various) | LZO | Class II | Orthopedic |
| 2025-11-05 | K250375 | Allure Hip Stem and Intramedullary Plugs | MEH | Class II | Orthopedic |
| 2025-05-16 | K243927 | MobileLink Acetabular Cup System - inhouse coatings | LZO | Class II | Orthopedic |
| 2024-11-08 | K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | LPH | Class II | Orthopedic |
| 2023-11-16 | K231445 | LINK Embrace Shoulder System - Reverse Configuration | PHX | Class II | Orthopedic |
| 2023-04-14 | K222066 | LINK MobileLink Acetabular Cup System | LPH | Class II | Orthopedic |
| 2023-03-21 | K230471 | LinkSymphoKnee Fixed Bearing Ultracongruent (FB UC) Articulating Surface | JWH | Class II | Orthopedic |
| 2022-09-13 | K213770 | SP-CL Hip Stem and LCU Hip System | LZO | Class II | Orthopedic |
| 2022-07-20 | K221794 | Vario-Cup System | KWY | Class II | Orthopedic |
| 2022-06-03 | K211567 | BiMobile Instruments (for BiMobile Dual Mobility System) | LZO | Class II | Orthopedic |
| 2022-05-03 | K220628 | LINK Endo-Model EVO Knee System | KRO | — | — |
| 2022-04-11 | K213675 | MP Reconstruction System | LZO | Class II | Orthopedic |
| 2021-11-18 | K212992 | LINK® Embrace Shoulder System - Reverse Configuration | PHX | Class II | Orthopedic |
| 2021-09-16 | K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating | JWH | Class II | Orthopedic |
| 2021-06-30 | K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | KRO | — | — |
| 2021-06-21 | K210899 | LINK Embrace Shoulder System- Anatomical Configuration | KWT | — | — |
| 2021-05-28 | K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters | LPH | Class II | Orthopedic |
| 2021-05-13 | K202924 | LinkSymphoKnee System | JWH | Class II | Orthopedic |
| 2021-02-05 | K200368 | LINK Embrace Shoulder System - Reverse Configuration | PHX | Class II | Orthopedic |
| 2020-07-17 | K201364 | LINK TrabecuLink Femoral Cones | MBH | Class II | Orthopedic |
| 2020-03-18 | K200113 | LINK TrabecuLink Tibial Cones | MBH | Class II | Orthopedic |