Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Techfit Digital Surgery, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250297 | TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. | 2025-10-27 | 269 | 0 |
| K242263 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | 2024-12-11 | 132 | 0 |
| K222577 | TECHFIT Diagnostic Models | Techfit Digital Surgery, Inc. | 2023-01-06 | 134 | 0 |
| K220199 | AFFINITY Proximal Tibia System | Techfit Digital Surgery, Inc. | 2022-03-21 | 56 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda