Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smith and Nephew, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
266 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222501 | Regeneten Bioinductive Implant | Smith and Nephew, Inc. | 2023-05-11 | 266 | 0 |
| K221740 | SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENAB | Smith and Nephew, Inc. | 2022-10-20 | 127 | 0 |
| K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control U | Smith and Nephew, Inc. | 2019-08-23 | 113 | 0 |
| K183232 | Double ENDOBUTTON Fixation Device | Smith and Nephew, Inc. | 2019-03-12 | 112 | 0 |
| K181746 | MICRORAPTOR Knotless Suture Anchor | Smith and Nephew, Inc. | 2018-09-28 | 88 | 0 |
| K180361 | MICRORAPTOR REGENESORB Suture Anchor | Smith and Nephew, Inc. | 2018-05-30 | 110 | 0 |
| K163034 | SUTUREFIX Curved Suture Anchor | Smith and Nephew, Inc. | 2016-12-07 | 37 | 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