Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smith & Nephew Endoscopy, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
89 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103309 | OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS | Smith & Nephew Endoscopy, Inc. | 2011-02-03 | 85 | 0 |
| K102660 | BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS | Smith & Nephew Endoscopy, Inc. | 2010-12-13 | 89 | 0 |
| K093428 | SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR | Smith & Nephew Endoscopy, Inc. | 2009-12-17 | 44 | 0 |
| K083226 | SMITH & NEPHEW PEEK INTERFERENCE SCREW | Smith & Nephew Endoscopy, Inc. | 2009-01-30 | 88 | 0 |
| K083635 | SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW | Smith & Nephew Endoscopy, Inc. | 2009-01-30 | 53 | 0 |
| K082095 | ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE | Smith & Nephew Endoscopy, Inc. | 2008-10-21 | 89 | 0 |
| K050580 | SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS | Smith & Nephew Endoscopy, Inc. | 2005-04-20 | 44 | 0 |
| K992396 | BIORCI SCREW | Smith & Nephew Endoscopy, Inc. | 2000-01-12 | 177 | 0 |
| K991500 | SMITH & NEPHEW SUTURE LOK | Smith & Nephew Endoscopy, Inc. | 1999-07-14 | 76 | 0 |
| K972599 | ACUFEX SCREW CANNULA | Smith & Nephew Endoscopy, Inc. | 1997-09-19 | 67 | 0 |
| K971939 | SMITH & NEPHEW SUTURE COLLET | Smith & Nephew Endoscopy, Inc. | 1997-08-06 | 71 | 0 |
| K970949 | SMITH & NEPHEW MIS INSTRUMENTS | Smith & Nephew Endoscopy, Inc. | 1997-04-23 | 40 | 0 |
| K970416 | ACUFEX DOUBLE ARMED SUTURE NEEDLE | Smith & Nephew Endoscopy, Inc. | 1997-04-21 | 76 | 0 |
| K964935 | SUTURE LOCK | Smith & Nephew Endoscopy, Inc. | 1997-02-25 | 77 | 0 |
| K964215 | ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM | Smith & Nephew Endoscopy, Inc. | 1996-12-20 | 59 | 4 |
| K963901 | ELECTROSURGICAL PROBE | Smith & Nephew Endoscopy, Inc. | 1996-11-04 | 38 | 0 |
| K962789 | SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM | Smith & Nephew Endoscopy, Inc. | 1996-08-14 | 28 | 0 |
| K961649 | ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER | Smith & Nephew Endoscopy, Inc. | 1996-07-16 | 77 | 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