Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smith & Nephew Inc., Endoscopy Div. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
390 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242631 | REGENETEN™ Bioinductive Implant | Smith & Nephew Inc., Endoscopy Div. | 2024-11-26 | 84 | 0 |
| K111843 | ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM | Smith & Nephew Inc., Endoscopy Div. | 2011-11-14 | 138 | 0 |
| K102544 | SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY | Smith & Nephew Inc., Endoscopy Div. | 2011-01-05 | 124 | 1 |
| K092551 | SMITH & NEPHEW INSTRUMENT TRAYS | Smith & Nephew Inc., Endoscopy Div. | 2010-09-14 | 390 | 0 |
| K100159 | SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Div. | 2010-04-19 | 89 | 4 |
| K093943 | BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM | Smith & Nephew Inc., Endoscopy Div. | 2010-03-05 | 73 | 0 |
| K093897 | SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Div. | 2010-03-04 | 76 | 0 |
| K073551 | SMITH & NEPHEW INSTRUMENT TRAYS | Smith & Nephew Inc., Endoscopy Div. | 2008-05-21 | 155 | 0 |
| K080358 | PLLA, HA SCREW | Smith & Nephew Inc., Endoscopy Div. | 2008-04-23 | 72 | 2 |
| K063726 | PLC SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Div. | 2007-03-06 | 81 | 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