restor3d, Inc.
Durham, NC, US
restor3d, inc. appears in FDA device records in Durham, NC. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for restor3d, Inc. between 2020 and 2026. The busiest year on record is 2025, with 5. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 5 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260556 | Veritas Shoulder System | PHX | Substantially Equivalent | |
| K253992 | Veritas Reverse Total Shoulder System | PHX | Substantially Equivalent | |
| K252067 | Velora Acetabular System | LPH | Substantially Equivalent | |
| K252454 | Kinos Total Ankle System | HSN | Substantially Equivalent | |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty System | PHX | Substantially Equivalent | |
| K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | MBH | Substantially Equivalent | |
| K242356 | TIDAL Fusion Cage System | SAI | Substantially Equivalent | |
| K242868 | Kinos Total Ankle System | HSN | Substantially Equivalent | |
| K241482 | Kinos Total Ankle System | HSN | Substantially Equivalent | |
| K240591 | restor3d Kinos Axiom Total Ankle System | HSN | Substantially Equivalent | |
| K234087 | restor3d TIDAL Lumbar Interbody Fusion System | MAX | Substantially Equivalent | |
| K232595 | Kinos Axiom Total Ankle System | HSN | Substantially Equivalent | |
| K231458 | Extremity Staple | JDR | Substantially Equivalent | |
| K223326 | Axiom PSR System | OYK | Substantially Equivalent | |
| K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | MAX | Substantially Equivalent | |
| K201393 | restor3d MTP Implant | KWD | Substantially Equivalent | |
| K211789 | restor3d Pin Implants | HTY | Substantially Equivalent | |
| K201314 | Restor3d Utility Wedge | PLF | Substantially Equivalent | |
| K193491 | restor3d Metallic Interference Screw | HWC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014833750 | 3014833750 | restor3d, inc. | 4001 NC Hwy 54, Suite 2160, Durham, NC 27709 US | 2026 | and 17 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OYKAnkle Arthroplasty Implantation System
- SAIAnkle Fusion Cage
- PLFBone Wedge
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- MDMInstrument, Manual, Surgical, General Use
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OOGKnee Arthroplasty Implantation System
- LXHOrthopedic Manual Surgical Instrument
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- KWDProsthesis, Toe, Hemi-, Phalangeal
- QYQProsthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal
- QNNProsthesis, Total Talus Replacement, Metal
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- QHEShoulder Arthroplasty Implantation System
- PHXShoulder Prosthesis, Reverse Configuration
- JDRStaple, Fixation, Bone
- HWTTemplate
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2987-2026 | 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: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The Veritas standard glenoid baseplate is the only component within scope of this field action. The patient-specific baseplate is unaffected by this defect and therefore not in scope. Component: Reverse Total Shoulder | Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. | Class II | Open, Classified | |
| Z-1028-2022 | Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). 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. | 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. | 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. Orthopedic manual surgical instrument | Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain