Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acumed Arh Slide-Loc
FDA 510(k) K131845 · Acumed, LLC
510(k) numberK131845
Submission
- Device name
- Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acumed Arh Slide-Loc
- Applicant
- Acumed, LLC
Hillsboro, OR, US - Received
- June 21, 2013
- Decision date
- September 30, 2013
- 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
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|---|---|---|---|
| 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 |
| K112030 | Synthes Radial Head Prosthesis SystemKWI · Traditional | Synthes USA, LLC | 06/19/2012SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K252356 | The Acumed Wrist Fixation System - 2.4mm ScrewsHRS · Special | 08/21/2025SE |
| K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsHRS · Abbreviated | 07/14/2025SE |
| K251296 | The Acumed Wrist Fixation SystemHRS · Traditional | 06/18/2025SE |
| K243624 | Acu-Sinch Knotless MiniHTN · Traditional | 01/23/2025SE |
| K233311 | Acumed Wrist Plating SystemHRS · Traditional | 04/22/2024SE |
| K230744 | Acumed Acutrak 3 Headless Compression Screw SystemHWC · Traditional | 06/09/2023SE |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalHWC · Traditional | 12/29/2022SE |
| K212990 | Acumed Ankle Syndesmosis Repair SystemHTN · Traditional | 01/07/2022SE |
| K210750 | Acumed Clavicle Hook Plating SystemHRS · Traditional | 07/15/2021SE |
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Questions and answers
When was Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acumed Arh Slide-Loc cleared by the FDA?
Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acumed Arh Slide-Loc (K131845) received a 510(k) decision of Substantially Equivalent on September 30, 2013, 101 days after the submission was received.
What is the product code of K131845?
The FDA product code is KWI – Prosthesis, Elbow, Hemi-, Radial, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3170.