Data / Medical devices / United States / restor3d, inc.
restor3d, inc.: FDA-registered device maker in Durham, NC, United States, 18 510(k) clearances
restor3d, inc. is registered with the FDA (registration 3014833750) in Durham, NC, United States. It lists 27 device types. The FDA files 18 510(k) clearances under its listings, the newest dated July 1, 2026. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014833750
- Address
- 4001 NC Hwy 54, Suite 2160, Durham, NC, United States, 27709
- Owner or operator
- restor3d, inc. (10058270)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 10, 2018
- Registered through
- 2026
- Brand names listed
- Kinos Aeros Ankle System, Kinos Axiom PSR System, Kinos Axiom Total Ankle System, OsseoREBAR Nail, Ossera AFX System, TIDAL Fusion Cage, Velora Acetabular Cup, Veritas Hemi Shoulder and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2026 | K260556 | Veritas Shoulder System | PHX | Substantially Equivalent | Restor3D | accessdata.fda.gov |
| May 7, 2026 | K253992 | Veritas Reverse Total Shoulder System | PHX | Substantially Equivalent | Restor3D | accessdata.fda.gov |
| December 5, 2025 | K252067 | Velora Acetabular System | LPH | Substantially Equivalent | Restor3D, Inc. | accessdata.fda.gov |
| May 19, 2025 | K243643 | restor3d Reverse Total Shoulder Arthroplasty System | PHX | Substantially Equivalent | Restor3D | accessdata.fda.gov |
| March 27, 2025 | K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System | MBH | Substantially Equivalent | Restor3D, Inc. | accessdata.fda.gov |
| March 24, 2025 | K242356 | TIDAL Fusion Cage System | SAI | Substantially Equivalent | Restor3D, Inc. | accessdata.fda.gov |
| October 18, 2024 | K242868 | Kinos Total Ankle System | HSN | Substantially Equivalent | Restor3D | accessdata.fda.gov |
| April 29, 2024 | K240591 | restor3d Kinos Axiom Total Ankle System | HSN | Substantially Equivalent | Restor3D, Inc. | accessdata.fda.gov |
| January 22, 2024 | K234087 | restor3d TIDAL Lumbar Interbody Fusion System | MAX | Substantially Equivalent | Restor3D | accessdata.fda.gov |
| November 28, 2023 | K232595 | Kinos Axiom Total Ankle System | HSN | Substantially Equivalent | Restor3D | accessdata.fda.gov |
| March 30, 2023 | K223326 | Axiom PSR System | OYK | Substantially Equivalent | Restor3D | accessdata.fda.gov |
| June 17, 2022 | K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | MAX | Substantially Equivalent | Restor3D | accessdata.fda.gov |
| May 25, 2022 | K201393 | restor3d MTP Implant | KWD | Substantially Equivalent | Restor3D, Inc. | accessdata.fda.gov |
| January 4, 2022 | K211789 | restor3d Pin Implants | HTY | Substantially Equivalent | Restor3D | accessdata.fda.gov |
| June 17, 2021 | K201314 | Restor3d Utility Wedge | PLF | Substantially Equivalent | Restor3D, Inc. | accessdata.fda.gov |
| June 30, 2020 | K192778 | Kinos Axiom Total Ankle System | HSN | Substantially Equivalent | Kinos Medical | accessdata.fda.gov |
| November 5, 2019 | K191047 | ADI TiDAL Osteotomy Wedge | PLF | Substantially Equivalent | Additive Device, Inc. (Adi) D/B/A Restor3D | accessdata.fda.gov |
| October 24, 2019 | K191812 | ADI Cervical Interbody Fusion Device | ODP | Substantially Equivalent | Additive Device, Inc. (Adi) D/B/A Restor3D | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 4, 2026 | 99940 | Class II | Ongoing | Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description: The restor3d Metatarsophalangeal (MTP) Implant is a sterile, single-use implant g | Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization. | accessdata.fda.gov |
| July 27, 2026 | 99512 | Class II | Ongoing | Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006 | Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery. | accessdata.fda.gov |
| June 30, 2026 | 99402 | Class II | Ongoing | Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: | Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. | accessdata.fda.gov |
| March 30, 2022 | 89983 | Class II | Terminated | Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument | Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium. | accessdata.fda.gov |
Compare with other makers
- All makers of Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- All makers of Shoulder Prosthesis, Reverse Configuration
Updated October 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.