Acumed Wrist Plating System
FDA 510(k)Class II (US FDA 510(k))
by Acumed, LLC
Identifiers
- 510(k) Number
- K233311 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Acumed Wrist Plating System is an orthopedic device used for wrist fractures, fusions, and osteotomies. It consists of anatomically contoured titanium plates with precise screw positioning to create a strong and stable construct. The system is designed to restore the natural anatomy of the wrist bones.
The Acumed Wrist Plating System is supplied in various plate families and is intended for surgical use. It is a traditional clearance type device with FDA 510K authorization. The device is manufactured by Acumed, LLC, and has a product code of HRS.
Frequently asked questions
What clinical situations is the Acumed Wrist Plating System intended for?
It is designed for surgical management of wrist fractures, wrist fusions, and osteotomies, providing anatomically contoured fixation that restores normal wrist anatomy and stability.
How is the system supplied and what sizes are available?
The system is supplied as a set of anatomically contoured titanium plates in various plate families, each matched to specific wrist bone geometries, allowing the surgeon to select the appropriate size for the patient’s anatomy.
Is the Acumed Wrist Plating System sterile and single‑use?
The plates are provided sterile for immediate surgical use and are intended for single‑use in the patient for which they are implanted, ensuring optimal sterility and performance.
What regulatory pathway was used for market clearance?
The device received traditional clearance through the FDA 510(k) process, demonstrating substantial equivalence to a legally marketed predicate device, as recorded in the decision description.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Acu-Loc Wrist Plating System | Acumed, Acu-Loc 2 Wrist Plating System | Acumed, Hand & Wrist Acu-Loc Wrist Plating System Acumed Distal Radius Fracture ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233311 | Class II | Active |
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Manufacturer
- Manufacturer
- Acumed, LLC
Sources (1)
- FDA 510(k) K233311 24 fields · synced Sep 23, 2026