Durham, NC, US · 19 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HSN | — | — | — | 5 | 2025-09-03 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | 3 | 2026-07-01 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 2 | 2024-01-22 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | 1 | 2025-12-05 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | 1 | 2025-03-27 |
| SAI | Ankle Fusion Cage | Class II | Orthopedic | 1 | 2025-03-24 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | 1 | 2023-08-03 |
| OYK | Ankle Arthroplasty Implantation System | Class II | Orthopedic | 1 | 2023-03-30 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Class II | Orthopedic | 1 | 2022-05-25 |
| HTY | — | — | — | 1 | 2022-01-04 |
| PLF | Bone Wedge | Class II | Orthopedic | 1 | 2021-06-17 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | 1 | 2020-03-19 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-03-30 | Class II | Terminated | Z-1028-2022 | Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instru… | — | During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots. |
| 2022-03-30 | Class II | Terminated | Z-1027-2022 | Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument | — | During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots. |
| 2022-03-30 | Class II | Terminated | Z-1026-2022 | Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. … | — | Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-01 | K260556 | Veritas Shoulder System | PHX | Class II | Orthopedic |
| 2026-05-07 | K253992 | Veritas Reverse Total Shoulder System | PHX | Class II | Orthopedic |
| 2025-12-05 | K252067 | Velora Acetabular System | LPH | Class II | Orthopedic |
| 2025-09-03 | K252454 | Kinos Total Ankle System | HSN | — | — |
| 2025-05-19 | K243643 | restor3d Reverse Total Shoulder Arthroplasty System | PHX | Class II | Orthopedic |
| 2025-03-27 | K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System | MBH | Class II | Orthopedic |
| 2025-03-24 | K242356 | TIDAL Fusion Cage System | SAI | Class II | Orthopedic |
| 2024-10-18 | K242868 | Kinos Total Ankle System | HSN | — | — |
| 2024-07-22 | K241482 | Kinos Total Ankle System | HSN | — | — |
| 2024-04-29 | K240591 | restor3d Kinos Axiom Total Ankle System | HSN | — | — |
| 2024-01-22 | K234087 | restor3d TIDAL Lumbar Interbody Fusion System | MAX | Class II | Orthopedic |
| 2023-11-28 | K232595 | Kinos Axiom Total Ankle System | HSN | — | — |
| 2023-08-03 | K231458 | Extremity Staple | JDR | Class II | Orthopedic |
| 2023-03-30 | K223326 | Axiom PSR System | OYK | Class II | Orthopedic |
| 2022-06-17 | K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | MAX | Class II | Orthopedic |
| 2022-05-25 | K201393 | restor3d MTP Implant | KWD | Class II | Orthopedic |
| 2022-01-04 | K211789 | restor3d Pin Implants | HTY | — | — |
| 2021-06-17 | K201314 | Restor3d Utility Wedge | PLF | Class II | Orthopedic |
| 2020-03-19 | K193491 | restor3d Metallic Interference Screw | HWC | Class II | Orthopedic |