Wrist Fusion Plate
by Dvo Extremity Solutions, LLC 510(k)
Active
510(k) K052754
Overview
The Wrist Fusion Plate is a metallic, multi-component bone fixation appliance designed for wrist arthrodesis and stabilization of fractures in small long bones, such as the clavicle and olecranon. It facilitates rigid internal fixation to promote fusion of carpal bones, addressing conditions like post-traumatic arthritis, rheumatoid deformities, or traumatic fractures requiring bony union.
This device is supplied as a reusable, sterile surgical implant intended for use in orthopedic procedures. It is classified under 21 CFR 888.3030 and has received FDA 510(k) clearance as substantially equivalent to predicate devices. Available in multiple reference codes (e.g., 1000114185, 2245304), the plate is designed for intraoperative application by surgeons and must be handled according to sterile surgical protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052754 | Date27 Oct 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LXT
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dvo Extremity Solutions, LLC
Questions
What types of wrist conditions is the Wrist Fusion Plate primarily designed to address during surgical procedures?
The Wrist Fusion Plate is specifically designed for wrist arthrodesis (fusion) and stabilization of fractures in small long bones, such as the clavicle and olecranon. It is intended to promote bony union in cases of post-traumatic arthritis, rheumatoid deformities, or traumatic fractures requiring rigid internal fixation to facilitate fusion of carpal bones.
Is the Wrist Fusion Plate intended for single-use or reusable applications, and how should it be handled?
The Wrist Fusion Plate is supplied as a reusable device and must be handled according to sterile surgical protocols. Since it is intended for intraoperative use, it should be sterilized and maintained in compliance with standard surgical implant procedures to ensure safety and efficacy.
What regulatory pathway was followed for FDA clearance of the Wrist Fusion Plate, and what classification does it fall under?
The Wrist Fusion Plate received FDA 510(k) clearance under the Traditional pathway, with a decision code of SESE (Substantially Equivalent). It is classified under 21 CFR 888.3030 and falls under the Orthopedic advisory committee (OR) for review. The device is also categorized as a Class II medical device.
How many different reference codes or product variants are associated with the Wrist Fusion Plate?
The Wrist Fusion Plate is available in multiple reference codes, including but not limited to: 1000114185, 2245304, 1000116912, 1020279, 2183449, and dozens more (over 70 distinct FEI numbers listed). These variants may correspond to different sizes, configurations, or surgical applications within the same device family.
What surgical specialties are most likely to use the Wrist Fusion Plate, and why?
The Wrist Fusion Plate is primarily intended for use by orthopedic surgeons, as indicated by its classification under Orthopedic medical specialty in regulatory records. Its design for wrist arthrodesis and fracture stabilization aligns with orthopedic procedures aimed at restoring bony union and joint stability.