Katalyst Radial Head Implant
FDA 510(k) K032806 · Kinetikos Medical, Inc.
510(k) numberK032806
Submission
- Device name
- Katalyst Radial Head Implant
- Applicant
- Kinetikos Medical, Inc.
Carlsbad, CA, US - Received
- September 9, 2003
- Decision date
- April 16, 2004
- 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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| 510(k) | Device | Decision |
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| K061749 | Eclipse Total Ankle ImplantHSN · Traditional | 11/22/2006SE |
| K061465 | Kmi Cement Restrictor ImplantJDK · Traditional | 10/05/2006SESU |
| K051611 | Mbaresorb ImplantHWC · Traditional | 09/06/2005SE |
| K041461 | Kmi Distal Volar Radius Plate SystemHRS · Traditional | 08/16/2004SE |
| K040356 | Kompressor Screw SystemHWC · Special | 03/01/2004SE |
| K024233 | Kompressor Screw SystemHWC · Traditional | 02/06/2003SE |
| K030037 | Universal Total Wrist SystemJWJ · Special | 02/05/2003SE |
| K023770 | K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)KWD · Special | 12/12/2002SE |
| K020554 | Modification to Universal Total Wrist SystemJWJ · Special | 05/03/2002SE |
| K991873 | Kmi Wrist Fusion SystemHRS · Traditional | 08/17/1999SE |
Questions and answers
When was Katalyst Radial Head Implant cleared by the FDA?
Katalyst Radial Head Implant (K032806) received a 510(k) decision of Substantially Equivalent on April 16, 2004, 220 days after the submission was received.
What is the product code of K032806?
The FDA product code is KWI – Prosthesis, Elbow, Hemi-, Radial, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3170.