Restor3D: FDA clearances and approvals
Restor3D has 19 FDA 510(k) clearances (first 2020, latest 2026), across 12 product codes in 1 review panel. Median 510(k) review time: 114 days. Since 2017 its median was 114 days, against 113 days for all cleared 510(k)s in the same product codes. openFDA lists 5 product recalls by a recalling firm named Restor3D. It is the industry lead sponsor of 8 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 93 |
| 2021 | 1 | 395 |
| 2022 | 3 | 208 |
| 2023 | 3 | 95 |
| 2024 | 4 | 45 |
| 2025 | 5 | 157 |
| 2026 | 2 | 139 |
Review time against the same product codes
Since 2017, Restor3D's cleared 510(k)s took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 5 | 5 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 1 | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 1 | 1 |
| OYK | Ankle Arthroplasty Implantation System | 1 | 1 |
Plus 2 more product codes.
Review panels
- Orthopedic (19)
Most recent Restor3D 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260556 | Veritas Shoulder System | PHX | 2026-07-01 | 132 |
| K253992 | Veritas Reverse Total Shoulder System | PHX | 2026-05-07 | 146 |
| K252067 | Velora Acetabular System | LPH | 2025-12-05 | 157 |
| K252454 | Kinos Total Ankle System | HSN | 2025-09-03 | 30 |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty System | PHX | 2025-05-19 | 174 |
| K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System | MBH | 2025-03-27 | 111 |
| K242356 | TIDAL Fusion Cage System | SAI | 2025-03-24 | 228 |
| K242868 | Kinos Total Ankle System | HSN | 2024-10-18 | 28 |
| K241482 | Kinos Total Ankle System | HSN | 2024-07-22 | 59 |
| K240591 | restor3d Kinos Axiom Total Ankle System | HSN | 2024-04-29 | 59 |
9 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 3 recall events; 5 initiated in the last five years. Most recent: 2026-07-27.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Restor3D is the industry lead sponsor of 8 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06311331: Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM) (Enrolling by invitation, started 2024-11-06)
- NCT05231304: Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (Completed, started 2022-04-05)
- NCT03289000: A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System (Completed, started 2017-04-24)
- NCT03152357: A Retrospective Study to Evaluate the ConforMIS iUni, iDuo & iTotal® KRS (Completed, started 2017-04-01)
- NCT02251522: A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf (Completed, started 2014-10)
Frequently asked questions
How many FDA 510(k) clearances does Restor3D have?
Restor3D has 19 FDA 510(k) clearances (first 2020, latest 2026), across 12 product codes in 1 review panel.
How long does FDA take to clear Restor3D's 510(k)s?
The median time from FDA receipt to decision across Restor3D's cleared 510(k)s is 114 days. Since 2017: 114 days, versus 113 days for all cleared 510(k)s in the same product codes.
What devices does Restor3D make?
Its most frequent FDA product codes are HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer, 5); PHX (Shoulder Prosthesis, Reverse Configuration, 3); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2).
Has Restor3D had device recalls?
openFDA lists 5 product recalls in 3 recall events by a recalling firm whose name matches Restor3D; the most recent began 2026-07-27. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 19 Restor3D clearances with predicates and recalls
- Run predicate analysis for product code HSN, Restor3D's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.