ALIGN Radial Head System
FDA 510(k) K231188 · Skeletal Dynamics, Inc.
510(k) numberK231188
Submission
- Device name
- ALIGN Radial Head System
- Applicant
- Skeletal Dynamics, Inc.
Miami, FL, US - Received
- April 26, 2023
- Decision date
- September 28, 2023
- 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
Other 510(k)s with product code KWI
| 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 |
| 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 |
| K112030 | Synthes Radial Head Prosthesis SystemKWI · Traditional | Synthes USA, LLC | 06/19/2012SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K261770 | Suture Button Repair SystemMBI · Traditional | 07/29/2026SE |
| K254288 | Clavicle Fixation SystemHRS · Abbreviated | 03/23/2026SE |
| K252949 | Geminus Volar Distal Radius Plating SystemHRS · Traditional | 11/13/2025SE |
| K242436 | Proximal Humerus Fixation SystemHRS · Traditional | 11/14/2024SE |
| K243381 | Total Wrist Arthroplasty System (TWA)JWJ · Special | 11/01/2024SE |
| K241815 | Protean Fragment Plating SystemHRS · Traditional | 09/26/2024SE |
| K242055 | Freefix Forearm Plating SystemHRS · Special | 08/01/2024SE |
| K240835 | Suture Button Repair SystemMBI · Traditional | 07/19/2024SE |
| K233574 | Total Wrist Arthroplasty System (TWA)JWJ · Traditional | 07/03/2024SE |
| K231447 | Double Internal Joint Stabilizer- ElbowOZI · Traditional | 12/15/2023SE |
Questions and answers
When was ALIGN Radial Head System cleared by the FDA?
ALIGN Radial Head System (K231188) received a 510(k) decision of Substantially Equivalent on September 28, 2023, 155 days after the submission was received.
What is the product code of K231188?
The FDA product code is KWI – Prosthesis, Elbow, Hemi-, Radial, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3170.