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Sign in to claim this brandCAYENNE MEDICAL, INC.
US
Last updated September 17, 2026
What CAYENNE MEDICAL, INC. makes
Cayenne Medical produces orthopaedic fixation devices, including non-bioabsorbable tendon/ligament anchors, non-bioabsorbable bone screws, and reusable surgical drill guides. Their portfolio also includes single-use arthroscopic procedure kits, fluted drill bits (both single-use and reusable), reusable bone taps, and reusable suturing units. These products are designed for orthopaedic surgeries, particularly tendon and ligament repairs.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. They are listed in the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Cayenne Medical, Inc. manufacture?
Cayenne Medical, Inc. specializes in orthopaedic fixation devices, primarily focused on non-bioabsorbable solutions. Their portfolio includes tendon/ligament bone anchors, non-bioabsorbable bone screws, reusable surgical drill guides, and single-use arthroscopic procedure kits. They also produce fluted surgical drill bits (both single-use and reusable), reusable bone taps, and reusable suturing units, all designed for orthopaedic surgeries like tendon and ligament repairs.
Where is Cayenne Medical, Inc. based?
Cayenne Medical, Inc. is headquartered in the United States. The company’s location influences its regulatory compliance, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA).
Which regulatory registries list Cayenne Medical’s devices?
Cayenne Medical’s devices are included in the FDA’s 510(k) Premarket Notification Database and the FDA’s Unique Device Identifier (UDI) System. These registries track devices that have undergone 510(k) clearance or UDI compliance, ensuring transparency in their regulatory status.
How are Cayenne Medical’s devices classified under FDA regulations?
Cayenne Medical’s devices are primarily classified as Class I (general controls) or Class II (special controls) under FDA regulations. Class I devices pose minimal risk and typically require general controls, while Class II devices, like some orthopaedic fixation products, may require additional performance standards or post-market surveillance due to moderate risk.
Why do some of Cayenne Medical’s devices appear in both single-use and reusable categories?
The distinction between single-use and reusable devices depends on their intended use and sterilization capabilities. Single-use items like arthroscopic procedure kits or disposable drill bits are designed for one-time use to ensure patient safety and hygiene. Reusable devices, such as surgical drill guides or bone taps, are engineered to withstand sterilization processes, reducing waste and cost for healthcare providers while maintaining regulatory compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 16597 N. 92ND STREET, SCOTTSDALE, AZ, 85260
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3006108336
- DUNS Number
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Catalogue (338)
Page 1 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AperFix® | CM-7270 | FDA UDI | Class I | Active |
| ACL Disposable Procedure Kit | CM-1501 | FDA UDI | Class I | Active |
| Quattro® | CM-9003 | FDA UDI | Class I | Active |
| Quattro® Bolt Tenodesis Screw | CM-9505 | FDA UDI | Class II | Active |
| Quattro® | CM-9129 | FDA UDI | Class II | Active |
| iFix® Interference Screw | CM-1820 | FDA UDI | Class II | Active |
| AperFix® | CM-3009C | FDA UDI | Class II | Active |
| Quattro® Bolt Tenodesis Screw | CM-9508 | FDA UDI | Class II | Active |
| Quattro® | CM-9145 | FDA UDI | Class II | Active |
| Drill Guide Obturator | CM9302 | FDA UDI | Class I | Active |
| Quattro® | CM-9155 | FDA UDI | Class II | Active |
| AperFix® | CM-7308 | FDA UDI | Class I | Active |
| Mirror™ | 100343 | FDA UDI | Class II | Unknown |
| Mirror™ | 100313 | FDA UDI | Class II | Unknown |
| Mirror™ | 100341 | FDA UDI | Class II | Unknown |
| AperFix® | CM-7611 | FDA UDI | Class I | Active |
| BioWick X® | CM-6201 | FDA UDI | Class I | Active |
| Mirror™ | 100317 | FDA UDI | Class II | Unknown |
| Quattro® | CM-9203 | FDA UDI | Class I | Active |
| Drill Guide, Curved, SureLock® 2.2mm | CM9625 | FDA UDI | Class I | Active |
| Quattro® | CM-9000UT | FDA UDI | Class I | Active |
| Quattro® | CM-9000U | FDA UDI | Class I | Active |
| Mirror™ | 100342 | FDA UDI | Class II | Unknown |
| Quattro® | CM-8010 | FDA UDI | Class I | Active |
| Quattro® | CM-9012 | FDA UDI | Class I | Active |
| Quattro® | CM-9001 | FDA UDI | Class I | Active |
| iFix® Interference Screw | CM-1925 | FDA UDI | Class II | Active |
| BioWick SureLock® | CM-6120 | FDA UDI | Class I | Active |
| Drill, Hard Bone, for 2.9mm Quattro® | CM-9324ST | FDA UDI | Class I | Active |
| BioWick X® | CM-6202 | FDA UDI | Class I | Active |
| Quattro® | CM-9145SP | FDA UDI | Class II | Active |
| Quattro® | CM-9010GTS | FDA UDI | Class I | Active |
| Drill (Soft Bone), Quattro® Link 4.5mm/5.5mm Anchor | CM9130 | FDA UDI | Class I | Active |
| AperFix® | CM-3008 | FDA UDI | Class II | Active |
| Mirror™ | 100314 | FDA UDI | Class II | Unknown |
| Accessory Portal Kit, 11mm | CM-7611 | FDA UDI | Class I | Active |
| AperFix® | CM-7010 | FDA UDI | Class I | Active |
| Quattro® | CM-9008 | FDA UDI | Class I | Active |
| Mirror™ | 100418 | FDA UDI | Class II | Unknown |
| Mirror™ | 100337 | FDA UDI | Class II | Unknown |
| iFix® Driver, 9-12mm | CM1345 | FDA UDI | Class I | Active |
| Obturator, BioWick™ SureLock® | CM-6121 | FDA UDI | Class I | Active |
| Quattro® | CM-9255BG | FDA UDI | Class II | Active |
| Quattro® | CM-9580 | FDA UDI | Class I | Active |
| Mirror™ | 100294 | FDA UDI | Class II | Unknown |
| Quattro® | CM-9508 | FDA UDI | Class II | Active |
| Tibial Implant Removal Tool | CM7300 | FDA UDI | Class I | Active |
| CrossFix® II Meniscal Repair Device | CM8001 | FDA UDI | Class II | Active |
| Ventix® | 110025998 | FDA UDI | Class I | Active |
| CrossFix® | CM-8002 | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Cayenne Medical, Inc. has three FDA recall records, all initiated between April 28, 2010, and October 10, 2013, with each classified as terminated. The recalls involved concerns over structural integrity, including a potential for the AperFix 24 mm implant to break inside the femoral socket, as well as identified trends of premature wear and/or breakage in the Coring Removal Drill and unspecified drills.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 10, 2013 | Z-2571-2018 | — | terminated | A review of complaints identified a trend for drills breaking. |
| Jul 11, 2013 | Z-2422-2018 | — | terminated | Potential for AperFix 24 mm implant breaking inside the drilled femoral socket. |
| Apr 28, 2010 | Z-2548-2018 | — | terminated | 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. |