# Cayenne Medical, Inc.

- Location (FDA's records): Scottsdale, AZ
- FDA decisions: 23 (2006–2019): 23 510(k) clearances
- Names in FDA's records: Cayenne Medical, Inc. (22); Cayenne Medical (1)
- Product codes: MBI (14), HWC (6), GAT (3)
- 510(k) review time since 2016: median 69 days, against 91 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 44 (8 its own); citations of its devices by later devices: 18 (8 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Teleflex Medical: 10 (https://510kreport.com/company/teleflex-medical)
- Teleflexmedical, Inc.: 4 (https://510kreport.com/company/teleflexmedical)
- Beere Precision Medical Instruments, Kmedic, Telef: 4 (https://510kreport.com/company/beere-precision-medical-instruments-kmedic-telef)
- Smith & Nephew Inc., Endoscopy Div.: 3 (https://510kreport.com/company/smith-nephew-endoscopy-div)
- Cp Medical: 2 (https://510kreport.com/company/cp-medical)
- Smith & Nephew Inc., Endoscopy Division: 2 (https://510kreport.com/company/smith-nephew-endoscopy-division)
- Depuy Mitek, A Johnson & Johnson Company: 2 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Mitek Worldwide: 1 (https://510kreport.com/company/mitek-worldwide)

## Firms that cite its devices most
- Ibalance Medical, Inc.: 2 (https://510kreport.com/company/ibalance-medical)
- Biomet Sports Medicine: 1 (https://510kreport.com/company/biomet-sports-medicine)
- Ots Medical, Ltd.: 1 (https://510kreport.com/company/ots-medical)
- Tigon Medical: 1 (https://510kreport.com/company/tigon-medical)
- Nanofiber Solutions, LLC: 1 (https://510kreport.com/company/nanofiber-solutions)
- T.A.G. Medical Products Corporation, Ltd.: 1 (https://510kreport.com/company/tag-medical-products)
- Oxford Performance Materials, Inc.: 1 (https://510kreport.com/company/oxford-performance-materials)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)

## Its most-cited devices
- K122314: Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek Only (2012), cited by 4
- K083607: Aperfix Implant with Inserter, 8, 9, 10, 11, MM X30 MM (2009), cited by 3
- K151068: SureLock W Suture Anchor (2015), cited by 2
- K172186: BioWick X Implant with Driver (2017), cited by 1
- K083612: Aperfix Femoral Implant with Inserter, 9,10,11 MM X 35MM and X 29MM (2009), cited by 1
- K161033: AFX™ Femoral Implant With Inserter (2016), cited by 1

## Recent decisions
- K192428: AFX Femoral Implant with Inserter (Oct 5, 2019)
- K180274: Ventix Link Knotless Anchor with Inserter (Mar 21, 2018)
- K172186: BioWick X Implant with Driver (Oct 16, 2017)
- K161033: AFX™ Femoral Implant With Inserter (Aug 3, 2016)
- K151068: SureLock W Suture Anchor (Jul 24, 2015)
- K143473: Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles (Mar 25, 2015)
- K143392: Quattro Bolt Tenodesis Screw (Jan 23, 2015)
- K132867: Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with Inserter, 2.2MM (Dec 30, 2013)

Source page: https://510kreport.com/company/cayenne-medical