Restor3D
Medical device manufacturer in Durham, NC.
19510(k) clearances
0PMA approvals
5recalls
Device types
- HSN Prosthesis, Ankle, Semi-Constrained… 5
- PHX Shoulder Prosthesis, Reverse Configuration 3
- MAX Intervertebral Fusion Device With Bone… 2
- HWC Screw, Fixation, Bone 1
- PLF Bone Wedge 1
- HTY Pin, Fixation, Smooth 1
- KWD Prosthesis, Toe, Hemi-, Phalangeal 1
- OYK Ankle Arthroplasty Implantation System 1
- JDR Staple, Fixation, Bone 1
- SAI Ankle Fusion Cage 1
- MBH Prosthesis, Knee, Patello/Femorotibial… 1
- LPH Prosthesis, Hip, Semi-Constrained… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260556 | Veritas Shoulder SystemPHX · Traditional | 07/01/2026SE |
| K253992 | Veritas Reverse Total Shoulder SystemPHX · Traditional | 05/07/2026SE |
| K252067 | Velora Acetabular SystemLPH · Traditional | 12/05/2025SE |
| K252454 | Kinos Total Ankle SystemHSN · Special | 09/03/2025SE |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty SystemPHX · Traditional | 05/19/2025SE |
| K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement SystemMBH · Traditional | 03/27/2025SE |
| K242356 | TIDAL Fusion Cage SystemSAI · Traditional | 03/24/2025SE |
| K242868 | Kinos Total Ankle SystemHSN · Special | 10/18/2024SE |
| K241482 | Kinos Total Ankle SystemHSN · Traditional | 07/22/2024SE |
| K240591 | restor3d Kinos Axiom Total Ankle SystemHSN · Traditional | 04/29/2024SE |
| K234087 | restor3d TIDAL Lumbar Interbody Fusion SystemMAX · Special | 01/22/2024SE |
| K232595 | Kinos Axiom Total Ankle SystemHSN · Traditional | 11/28/2023SE |
| K231458 | Extremity StapleJDR · Traditional | 08/03/2023SE |
| K223326 | Axiom PSR SystemOYK · Traditional | 03/30/2023SE |
| K220523 | restor3d TiDAL Lumbar Interbody Fusion DeviceMAX · Traditional | 06/17/2022SE |
| K201393 | restor3d MTP ImplantKWD · Traditional | 05/25/2022SE |
| K211789 | restor3d Pin ImplantsHTY · Traditional | 01/04/2022SE |
| K201314 | Restor3d Utility WedgePLF · Traditional | 06/17/2021SE |
| K193491 | restor3d Metallic Interference ScrewHWC · Traditional | 03/19/2020SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-3178-2026 | Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result… | 07/27/2026Open, Classified |
| Z-2987-2026 Class II | Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard…Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the… | 06/30/2026Open, Classified |
| Z-1028-2022 Class II | Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818).…During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts… | 03/30/2022Terminated |
| Z-1027-2022 Class II | Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018).…During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts… | 03/30/2022Terminated |
| Z-1026-2022 Class II | Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical…Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium. | 03/30/2022Terminated |