Kapp Custom Radial Head Elbow Implant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K030237 FDA 510(k)
- FDA Product Code
- KWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3170 FDA 510(k)
- Regulation Number
- 888.3170 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a prosthesis, elbow, hemi-, radial, polymer, as defined in the device data. It is a custom radial head elbow implant designed for use in orthopedic applications.
The implant is supplied as a sterile, single-use device. It received FDA 510(k) clearance (K030237) on August 29, 2003, and is classified as a Class II medical device under regulation number 888.3170.
Frequently asked questions
What is the KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT used for?
This device is a prosthesis designed to replace the radial head of the elbow joint in orthopedic applications. It is a hemi-elbow implant made of polymer, intended for use in patients requiring radial head replacement due to trauma, arthritis, or other joint pathology where preservation of elbow function is needed.
How is the KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT supplied and is it reusable?
The implant is supplied as a sterile, single-use device. It is not intended for reuse; each implant is designed for one surgical procedure only and must be discarded after use to maintain sterility and structural integrity.
What regulatory clearance does the KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT have and when was it granted?
The device received FDA 510(k) clearance under submission number K030237 on August 29, 2003. It was determined to be substantially equivalent to a predicate device and is classified as a Class II medical device under regulation 888.3170.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030237 | Class II | Active |
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Manufacturer
- Manufacturer
- Kapp Surgical Instrument, Inc.
Sources (1)
- FDA 510(k) K030237 24 fields · synced Oct 6, 2026