Cfn-Cannulated Femur Nail, Ctn-Cannulated Tibia Nail, Chn-Cannulated Humeral Na…
FDA 510(k)Class II (US FDA 510(k))
by I.T.S. GmbH
Identifiers
- 510(k) Number
- K132945 FDA 510(k)
- FDA Product Code
- HSB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3020 FDA 510(k)
- Regulation Number
- 888.3020 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cannulated Femur Nail (CFN), Cannulated Tibia Nail (CTN), and Cannulated Humeral Nail (CHN) are intramedullary fixation rods designed for internal fixation of long bone fractures. These devices are intended for use in the femur, tibia, and humerus, providing stable fixation to promote proper alignment and healing of complex fractures, including multi-part, displaced, or unstable fractures, as well as pseudoarthrosis cases.
These nails are supplied sterile and intended for single-use. They are classified under FDA Product Code HSB and were granted 510(k) clearance under Traditional Review by the Orthopedic (OR) Advisory Committee. The devices are manufactured by I.T.S. GmbH and are intended for use in orthopedic trauma surgery settings. No additional regulatory status beyond the stated 510(k) clearance is implied.
Frequently asked questions
What are the CFN, CTN, and CHN cannulated nails used for?
These nails are designed for internal fixation of long bone fractures in the femur (CFN), tibia (CTN), and humerus (CHN). They provide stable fixation to help align and heal complex fractures, including multi-part, displaced, unstable fractures, and pseudoarthrosis cases. Their cannulated design allows for easier insertion and reduces trauma to the bone during placement.
Are the cannulated nails supplied sterile and for single-use?
Yes, the cannulated nails are supplied sterile and are intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the integrity of the device for optimal clinical performance.
How are these nails classified and regulated?
The cannulated nails fall under FDA Product Code HSB and were granted 510(k) clearance through Traditional Review by the Orthopedic (OR) Advisory Committee. This classification confirms they are substantially equivalent to a legally marketed predicate device, ensuring compliance with U.S. regulatory standards for orthopedic trauma fixation.
What types of fractures are these nails intended to treat?
These nails are specifically intended for treating complex fractures, such as multi-part, displaced, or unstable fractures, as well as pseudoarthrosis cases. Their design supports proper alignment and stabilization, promoting optimal healing in critical orthopedic trauma scenarios.
Where are these devices manufactured and by whom?
The cannulated nails are manufactured by I.T.S. GmbH, a company based in Germany. The devices are supplied in the U.S. and are intended for use in orthopedic trauma surgery settings to address fractures requiring intramedullary fixation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cfn-cannulated Femur Nail, Ctn-cannulated Tibia Nail, Chn-cannulated ..., Cfn-cannulated Femur Nail, Ctn-cannulated Tibia Nail, Chn-cannulated ..., PDF CFN - its-implant.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132945 | Class II | Active |
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Manufacturer
- Manufacturer
- I.T.S. GmbH
Sources (1)
- FDA 510(k) K132945 24 fields · synced Oct 6, 2026