Evolve Ceramic Radial Head Implant
FDA 510(k) K030384 · Wrightmedicaltechnologyinc
510(k) numberK030384
Submission
- Device name
- Evolve Ceramic Radial Head Implant
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- February 5, 2003
- Decision date
- August 12, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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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Questions and answers
When was Evolve Ceramic Radial Head Implant cleared by the FDA?
Evolve Ceramic Radial Head Implant (K030384) received a 510(k) decision of Substantially Equivalent on August 12, 2003, 188 days after the submission was received.
What is the product code of K030384?
The FDA product code is KWI – Prosthesis, Elbow, Hemi-, Radial, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3170.