Cayenne Medical Inc.
Scottsdale, AZ, US
CAYENNE MEDICAL, INC. appears in FDA device records in Scottsdale, AZ. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Cayenne Medical Inc. between 2006 and 2019. The busiest year on record is 2012, with 5. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 3 |
| 2011 | 1 |
| 2012 | 5 |
| 2013 | 2 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K192428 | AFX Femoral Implant with Inserter | MBI | Substantially Equivalent | |
| K180274 | Ventix Link Knotless Anchor with Inserter | MBI | Substantially Equivalent | |
| K172186 | BioWick X Implant with Driver | MBI | Substantially Equivalent | |
| K161033 | AFX™ Femoral Implant With Inserter | MBI | Substantially Equivalent | |
| K151068 | SureLock W Suture Anchor | MBI | Substantially Equivalent | |
| 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 | MBI | Substantially Equivalent | |
| K143392 | Quattro Bolt Tenodesis Screw | MBI | Substantially Equivalent | |
| K132867 | SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM | MBI | Substantially Equivalent | |
| K131325 | QUATTRO GL SUTURE ANCHOR | MBI | Substantially Equivalent | |
| K122314 | QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY | MBI | Substantially Equivalent | |
| K122463 | APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W | MBI | Substantially Equivalent | |
| K121413 | CROSSFIX II MEMISCAL REPAIR DEVICE | GAT | Substantially Equivalent | |
| K112814 | CUFFINK | MBI | Substantially Equivalent | |
| K112960 | LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE | MBI | Substantially Equivalent | |
| K112876 | CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 | MBI | Substantially Equivalent | |
| K083612 | APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM | HWC | Substantially Equivalent | |
| K083607 | APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM | HWC | Substantially Equivalent | |
| K082518 | DUAL NEEDLE SUTURE PASSER SYSTEM | GAT | Substantially Equivalent | |
| K073426 | APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM | HWC | Substantially Equivalent | |
| K073054 | MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER | HWC | Substantially Equivalent | |
| K071796 | CAPSEW PLICATION SYSTEM | GAT | Substantially Equivalent | |
| K063070 | APERFIX TIBIAL IMPLANT WITH INSERTER | HWC | Substantially Equivalent | |
| K062487 | APERFIX FEMORAL IMPLANT WITH INSERTER | HWC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006108336 | 3006108336 | CAYENNE MEDICAL, INC. | 16597 N. 92ND STREET, SCOTTSDALE, AZ 85260 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- HWJAwl
- HTWBit, Drill
- GEACannula, Surgical, General & Plastic Surgery
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- GABNeedle, Suturing, Disposable
- LXHOrthopedic Manual Surgical Instrument
- HTOReamer
- HWCScrew, Fixation, Bone
- OVNSuture Kit
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- HWXTap, Bone
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2571-2018 | Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324 | A review of complaints identified a trend for drills breaking. | Class II | Terminated | |
| Z-2422-2018 | AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction. | Potential for AperFix 24 mm implant breaking inside the drilled femoral socket. | Class II | Terminated | |
| Z-2548-2018 | AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument. | A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain