Metallic Radial Head Implants
FDA 510(k) K944507 · Wrightmedicaltechnologyinc
510(k) numberK944507
Submission
- Device name
- Metallic Radial Head Implants
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- September 15, 1994
- Decision date
- July 13, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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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Questions and answers
When was Metallic Radial Head Implants cleared by the FDA?
Metallic Radial Head Implants (K944507) received a 510(k) decision of Substantially Equivalent for Some Indications on July 13, 1995, 301 days after the submission was received.
What is the product code of K944507?
The FDA product code is KWI – Prosthesis, Elbow, Hemi-, Radial, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3170.