The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws
FDA 510(k) K251132 · Acumed, LLC
510(k) numberK251132
Submission
- Device name
- The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws
- Applicant
- Acumed, LLC
Hillsboro, OR, US - Received
- April 11, 2025
- Decision date
- July 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K252356 | The Acumed Wrist Fixation System - 2.4mm ScrewsHRS · Special | 08/21/2025SE |
| 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 |
| K151886 | Acumed Ankle and Small Fragment Base Set UpdateHRS · Traditional | 10/30/2015SE |
| K143385 | Acumed Ankle Plating SystemHRS · Traditional | 04/06/2015SE |
Questions and answers
When was The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws cleared by the FDA?
The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws (K251132) received a 510(k) decision of Substantially Equivalent on July 14, 2025, 94 days after the submission was received.
What is the product code of K251132?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.