Techfit Digital Surgery, Inc.: FDA clearances and approvals
Techfit Digital Surgery, Inc. has 5 FDA 510(k) clearances (first 2022, latest 2025), across 4 product codes in 4 review panels. Median 510(k) review time: 134 days. Since 2017 its median was 134 days, against 112 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 56 |
| 2023 | 2 | 138 |
| 2024 | 1 | 132 |
| 2025 | 1 | 269 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Techfit Digital Surgery, Inc.'s cleared 510(k)s took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZJ | Driver, Wire, And Bone Drill, Manual | 2 | 2 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Dental (2)
- Neurology (1)
- Orthopedic (1)
- Radiology (1)
Most recent Techfit Digital Surgery, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250297 | TECHFIT Patient-Specific Cranial System | GWO | 2025-10-27 | 269 |
| K242263 | TECHFIT DISRP® System | DZJ | 2024-12-11 | 132 |
| K230276 | TECHFIT DISRP® System | DZJ | 2023-06-23 | 142 |
| K222577 | TECHFIT Diagnostic Models | LLZ | 2023-01-06 | 134 |
| K220199 | AFFINITY Proximal Tibia System | HRS | 2022-03-21 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Techfit Digital Surgery, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances does Techfit Digital Surgery, Inc. have?
Techfit Digital Surgery, Inc. has 5 FDA 510(k) clearances (first 2022, latest 2025), across 4 product codes in 4 review panels.
How long does FDA take to clear Techfit Digital Surgery, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Techfit Digital Surgery, Inc.'s cleared 510(k)s is 134 days. Since 2017: 134 days, versus 112 days for all cleared 510(k)s in the same product codes.
What devices does Techfit Digital Surgery, Inc. make?
Its most frequent FDA product codes are DZJ (Driver, Wire, And Bone Drill, Manual, 2); GWO (Plate, Cranioplasty, Preformed, Alterable, 1); HRS (Plate, Fixation, Bone, 1).
Has Techfit Digital Surgery, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Techfit Digital Surgery, Inc. Related entities may recall under other names.
Next steps
- See all 5 Techfit Digital Surgery, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZJ, Techfit Digital Surgery, Inc.'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.