Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cayenne Medical, Inc. · Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
112 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180274 | Ventix Link Knotless Anchor with Inserter | Cayenne Medical, Inc. | 2018-03-21 | 49 | 0 |
| K172186 | BioWick X Implant with Driver | Cayenne Medical, Inc. | 2017-10-16 | 88 | 0 |
| K161033 | AFX™ Femoral Implant With Inserter | Cayenne Medical, Inc. | 2016-08-03 | 112 | 0 |
| K151068 | SureLock W Suture Anchor | Cayenne Medical, Inc. | 2015-07-24 | 94 | 0 |
| K143473 | Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMW | Cayenne Medical, Inc. | 2015-03-25 | 110 | 0 |
| K143392 | Quattro Bolt Tenodesis Screw | Cayenne Medical, Inc. | 2015-01-23 | 58 | 0 |
| K132867 | SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK AL | Cayenne Medical, Inc. | 2013-12-30 | 108 | 0 |
| K131325 | QUATTRO GL SUTURE ANCHOR | Cayenne Medical, Inc. | 2013-08-16 | 100 | 0 |
| K122314 | QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY | Cayenne Medical, Inc. | 2012-10-31 | 91 | 0 |
| K122463 | APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FE | Cayenne Medical, Inc. | 2012-10-11 | 59 | 0 |
| K121413 | CROSSFIX II MEMISCAL REPAIR DEVICE | Cayenne Medical, Inc. | 2012-06-04 | 24 | 0 |
| K112814 | CUFFINK | Cayenne Medical, Inc. | 2012-01-17 | 112 | 0 |
| K112960 | LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH | Cayenne Medical, Inc. | 2012-01-09 | 96 | 0 |
| K112876 | CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PE | Cayenne Medical, Inc. | 2011-12-15 | 76 | 0 |
| K083612 | APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND | Cayenne Medical, Inc. | 2009-03-04 | 89 | 0 |
| K083607 | APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM | Cayenne Medical, Inc. | 2009-03-04 | 89 | 0 |
| K082518 | DUAL NEEDLE SUTURE PASSER SYSTEM | Cayenne Medical, Inc. | 2009-01-16 | 136 | 0 |
| K073426 | APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; | Cayenne Medical, Inc. | 2008-02-19 | 76 | 0 |
| K073054 | MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER | Cayenne Medical, Inc. | 2007-11-27 | 28 | 0 |
| K071796 | CAPSEW PLICATION SYSTEM | Cayenne Medical, Inc. | 2007-10-19 | 109 | 0 |
| K063070 | APERFIX TIBIAL IMPLANT WITH INSERTER | Cayenne Medical, Inc. | 2006-12-14 | 69 | 0 |
| K062487 | APERFIX FEMORAL IMPLANT WITH INSERTER | Cayenne Medical, Inc. | 2006-11-17 | 84 | 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