Company · US
Restor3D
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2026. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (4 in 12 months)
6recalls (3 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 5 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 5 |
| LXH | Orthopedic Manual Surgical Instrument | 3 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 |
| OYK | Ankle Arthroplasty Implantation System | 2 |
| HTY | Pin, Fixation, Smooth | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| JDR | Staple, Fixation, Bone | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 1 |
| PLF | Bone Wedge | 1 |
| SAI | Ankle Fusion Cage | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2026 | K263421 | Veritas Shoulder System restor3d, inc. | PHX |
| Jul 1, 2026 | K260556 | Veritas Shoulder System Restor3D | PHX |
| May 7, 2026 | K253992 | Veritas Reverse Total Shoulder System Restor3D | PHX |
| Dec 5, 2025 | K252067 | Velora Acetabular System Restor3D, Inc. | LPH |
| Sep 3, 2025 | K252454 | Kinos Total Ankle System Restor3D | HSN |
| May 19, 2025 | K243643 | restor3d Reverse Total Shoulder Arthroplasty System Restor3D | PHX |
| Mar 27, 2025 | K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System Restor3D, Inc. | MBH |
| Mar 24, 2025 | K242356 | TIDAL Fusion Cage System Restor3D, Inc. | SAI |
| Oct 18, 2024 | K242868 | Kinos Total Ankle System Restor3D | HSN |
| Jul 22, 2024 | K241482 | Kinos Total Ankle System Restor3D | HSN |
| Apr 29, 2024 | K240591 | restor3d Kinos Axiom Total Ankle System Restor3D, Inc. | HSN |
| Jan 22, 2024 | K234087 | restor3d TIDAL Lumbar Interbody Fusion System Restor3D | MAX |
| Nov 28, 2023 | K232595 | Kinos Axiom Total Ankle System Restor3D | HSN |
| Aug 3, 2023 | K231458 | Extremity Staple Restor3D | JDR |
| Mar 30, 2023 | K223326 | Axiom PSR System Restor3D | OYK |
| Jun 17, 2022 | K220523 | restor3d TiDAL Lumbar Interbody Fusion Device Restor3D | MAX |
| May 25, 2022 | K201393 | restor3d MTP Implant Restor3D, Inc. | KWD |
| Jan 4, 2022 | K211789 | restor3d Pin Implants Restor3D | HTY |
| Jun 17, 2021 | K201314 | Restor3d Utility Wedge Restor3D, Inc. | PLF |
| Mar 19, 2020 | K193491 | restor3d Metallic Interference Screw Restor3D | HWC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | restor3d Inc. 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, Open, Classified |
KWD | K201393 |
| Sep 16, 2026 | restor3d Inc. Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006 Open, Classified |
OYK | K223326 |
| Aug 19, 2026 | restor3d Inc. 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
P Open, Classified |
PHX | K243643 |
| Apr 29, 2022 | restor3d Inc. Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument Terminated |
LXH | None listed |
| Apr 29, 2022 | restor3d Inc. Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument Terminated |
LXH | None listed |
| Apr 29, 2022 | restor3d Inc. Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument Terminated |
LXH | None listed |