Avenger Radial Head System
FDA 510(k) K212872 · In2bones USA, LLC
510(k) numberK212872
Submission
- Device name
- Avenger Radial Head System
- Applicant
- In2bones USA, LLC
Memphis, TN, US - Received
- September 9, 2021
- Decision date
- December 17, 2021
- 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 |
| K213563 | DePuy Synthes Radial Head Replacement SystemKWI · Traditional | DePuy Synthes | 03/18/2022SE |
| 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 |
|---|---|---|
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | 05/30/2026SE |
| K241387 | CoLink NeoFuse MIS Plating System (see attached parts list)HRS · Traditional | 08/13/2024SE |
| K233089 | NeoSpan® Compression Implant SystemHRS · Traditional | 05/24/2024SE |
| K231236 | IBS-B MIS Beveled Screw SystemHWC · Traditional | 07/27/2023SE |
| K213698 | CoLink PCR Plating SystemHRS · Traditional | 05/27/2022SE |
| K220260 | Hercules Syndesmosis Implant SystemHTN · Traditional | 03/31/2022SE |
| K213069 | CoLink NeoFuse Plating SystemHRS · Traditional | 12/13/2021SE |
| K212487 | CoLink Vallux Plating SystemHRS · Traditional | 11/18/2021SE |
| K203698 | CoLink Sfx Implant SystemHTY · Traditional | 05/04/2021SE |
| K210060 | CoLink Mfx Implant SystemHRS · Traditional | 03/12/2021SE |
Questions and answers
When was Avenger Radial Head System cleared by the FDA?
Avenger Radial Head System (K212872) received a 510(k) decision of Substantially Equivalent on December 17, 2021, 99 days after the submission was received.
What is the product code of K212872?
The FDA product code is KWI – Prosthesis, Elbow, Hemi-, Radial, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3170.