DePuy Synthes Radial Head Replacement System
FDA 510(k) K213563 · DePuy Synthes
510(k) numberK213563
Submission
- Device name
- DePuy Synthes Radial Head Replacement System
- Applicant
- DePuy Synthes
West Chester, PA, US - Received
- November 9, 2021
- Decision date
- March 18, 2022
- 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 |
| K231188 | ALIGN Radial Head SystemKWI · Traditional | Skeletal Dynamics, Inc. | 09/28/2023SE |
| 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 |
More from Synthes USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K233696 | DePuy Synthes Retrograde Femoral Nail Advanced SystemHSB · Traditional | 08/01/2024SE |
| K233256 | Robotic Integration InstrumentsOLO · Traditional | 06/17/2024SE |
| K233255 | CROSSNAV Navigation Enabled InstrumentsOLO · Traditional | 06/17/2024SE |
| K233254 | TELIGEN System Navigation Ready InstrumentsOLO · Traditional | 06/14/2024SE |
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…HRS · Traditional | 03/21/2024SE |
| K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemKTT · Special | 07/26/2023SE |
| K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular SystemHRS · Traditional | 09/20/2022SE |
| K211051 | DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)HRS · Traditional | 06/02/2021SE |
| K203414 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle…HRS · Special | 12/16/2020SE |
| K201959 | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate SystemHRS · Traditional | 09/11/2020SE |
Questions and answers
When was DePuy Synthes Radial Head Replacement System cleared by the FDA?
DePuy Synthes Radial Head Replacement System (K213563) received a 510(k) decision of Substantially Equivalent on March 18, 2022, 129 days after the submission was received.
What is the product code of K213563?
The FDA product code is KWI – Prosthesis, Elbow, Hemi-, Radial, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3170.