Distal Volar Radius Anatomical Plate System

• • Terminated Z-1300-2022 FDA Class II ·initiated 2 Jun 2022

  One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates

510(k) Number

K050932 ↗

FDA Product Code

LXT

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Fragment Plate System, Screws, Pins and K-Wires

  Class II

  FDA 510(k) K041081 Active Cleared 1 Jul 2004

• Shoulder Fixation System

  Class II

  FDA 510(k) K042059 Active Cleared 30 Sep 2004

• Small Bone Fixation System

  Class II

  FDA 510(k) K033406 Active Cleared 15 Jan 2004

• Modification to Small Bone Fixation System

  Class II

  FDA 510(k) K041157 Active Cleared 30 Jul 2004

• Distal Radius Fracture Repair System

  Class II

  FDA 510(k) K032705 Active Cleared 1 Oct 2003

• Hand Innovations, Inc. Distal Radius Fracture Repair System

  Class II

  FDA 510(k) K030198 Active Cleared 1 Apr 2003

See all devices from Hand Innovations, LLC →

• What types of fractures is this plate system designed to treat, and how does it provide stability?

  The Distal Volar Radius Anatomical Plate System is specifically designed for internal fixation of fractures and osteotomies in the distal radius, including both simple and comminuted (severely broken) fracture patterns. It combines a volar (front-side) plate with screws to offer stable three-dimensional fixation, ensuring proper alignment and support during healing. The system accommodates anatomical variations through multiple component sizes, allowing for tailored treatment.

• Is this device single-use or reusable, and how should it be stored?

  The Distal Volar Radius Anatomical Plate System is supplied as a reusable, sterile device. Proper storage must adhere to the manufacturer’s guidelines for metallic orthopedic implants to maintain sterility and functionality. Since it is reusable, it should be cleaned, inspected, and sterilized according to established protocols before each use.

• What regulatory pathway was followed for this device’s approval, and what class does it fall under?

  The Distal Volar Radius Anatomical Plate System received FDA clearance through the 510(k) pathway, which demonstrates it is substantially equivalent to a legally marketed device. It is classified as a Class II medical device under FDA regulations, indicating it poses moderate risk and requires special controls to ensure safety and effectiveness.

• How many sizes or models are available, and why does this matter for surgical planning?

  The system includes multiple component sizes to match anatomical variations in the distal radius. This variety ensures surgeons can select the appropriate plate and screws for each patient, improving fit, stability, and outcomes for fractures or osteotomies. The availability of different sizes accommodates diverse patient anatomies, enhancing versatility in orthopedic procedures.