Cedar Knolls, NJ, US · 8 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 4 | 2022-10-06 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | 2 | 2024-11-15 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | 1 | 2026-04-13 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Class II | Orthopedic | 1 | 2021-11-04 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-13 | K253357 | b-ONE® Bipolar Head | KWY | Class II | Orthopedic |
| 2024-11-15 | K240528 | b-ONE® Total Hip System | LZO | Class II | Orthopedic |
| 2022-10-06 | K222431 | b-ONER MOBIO Total Knee System | JWH | Class II | Orthopedic |
| 2022-01-21 | K213673 | b-ONE MOBIO Total Knee System | JWH | Class II | Orthopedic |
| 2021-11-04 | K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System | MAI | Class II | Orthopedic |
| 2021-04-21 | K210483 | MOBIO Total Knee System | JWH | Class II | Orthopedic |
| 2021-04-01 | K202768 | KOSMO Femoral Stem | LZO | Class II | Orthopedic |
| 2020-10-23 | K202429 | Mobio Total Knee System | JWH | Class II | Orthopedic |