Kapp Custom Radial Head Elbow Implant
FDA 510(k) K030237 · Kapp Surgical Instrument, Inc.
510(k) numberK030237
Submission
- Device name
- Kapp Custom Radial Head Elbow Implant
- Applicant
- Kapp Surgical Instrument, Inc.
Warrensville, OH, US - Received
- January 23, 2003
- Decision date
- August 29, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWI – Prosthesis, Elbow, Hemi-, Radial, Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3170
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K260624 | Arthrex Radial Head Replacement SystemKWI · Traditional | Arthrex, Inc. | 07/30/2026SE |
| K233592 | BioPoly Radial Head ImplantKWI · Traditional | BioPoly, LLC | 03/13/2024SE |
| K231188 | ALIGN Radial Head SystemKWI · Traditional | Skeletal Dynamics, Inc. | 09/28/2023SE |
| K213563 | DePuy Synthes Radial Head Replacement SystemKWI · Traditional | DePuy Synthes | 03/18/2022SE |
| K212872 | Avenger Radial Head SystemKWI · Traditional | In2bones USA, LLC | 12/17/2021SE |
| K192754 | Avenger Radial Head SystemKWI · Traditional | In2bones USA, LLC | 01/07/2020SE |
| K183618 | Revolution Radial HeadKWI · Traditional | Ignite Orthopedics, Inc. | 05/17/2019SE |
| K172688 | Align Radial Head SystemKWI · Special | Skeletal Dynamics, LLC | 12/22/2017SE |
| K132735 | Axia Radial Head SystemKWI · Traditional | Imds (Innovative MEdical Device Systems) - Leis ME | 01/07/2014SE |
| K131845 | Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acumed Arh…KWI · Traditional | Acumed, LLC | 09/30/2013SE |
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| K050384 | Kapp Bari-Ring, Model KS-BR-2005NEU · Traditional | 01/13/2006SE |
| K050657 | Mondeal Contour Ho SystemHRS · Traditional | 08/08/2005SE |
| K050655 | Mondeal Radius Ho System, Model KS-MR-2005HRS · Traditional | 08/08/2005SE |
| K033930 | Kapp Custom Ulnar Head Wrist ImplantKXE · Traditional | 07/28/2004SE |
| K844177 | Cosgrove Mitral Valve RetractorGAD · Traditional | 11/08/1984SE |
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Questions and answers
When was Kapp Custom Radial Head Elbow Implant cleared by the FDA?
Kapp Custom Radial Head Elbow Implant (K030237) received a 510(k) decision of Substantially Equivalent on August 29, 2003, 218 days after the submission was received.
What is the product code of K030237?
The FDA product code is KWI – Prosthesis, Elbow, Hemi-, Radial, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3170.