Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Acuitive Technologies, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
227 daysmedian FDA review time
270 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240450 | Citrepore™ | Acuitive Technologies, Inc. | 2024-11-06 | 265 | 0 |
| K232592 | CITRELOCK® DUO | Acuitive Technologies, Inc. | 2023-09-20 | 26 | 0 |
| K221468 | Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon | Acuitive Technologies, Inc. | 2023-02-14 | 270 | 0 |
| K220833 | Citregen Tendon Interference Screw, Citrelock, Citrefix, Cit | Acuitive Technologies, Inc. | 2022-11-04 | 227 | 0 |
| K210239 | CITRESPLINE and CITRELOCK ACL Implants | Acuitive Technologies, Inc. | 2021-02-24 | 26 | 0 |
| K203334 | The Citrefix Knotless Suture Anchor | Acuitive Technologies, Inc. | 2021-02-05 | 85 | 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