DePuy Synthes Variable Angle Locking Hand System
by Synthes (Usa) 510(k)
Active
510(k) K141527
Overview
The Variable Angle Locking Hand System is an orthopedic device designed for internal fixation of fractures in the hand. It consists of 40 different basic and specialty plates made from stainless steel and titanium, including fragment-specific plates for lateral and dorsal application in fracture repair and deformity correction.
The system is supplied as a set of plates and associated components for surgical use in hand fracture management. It is provided non-sterile and intended for single-use or reusable application depending on the specific component, with no MRI safety information provided in the data. Storage and handling should follow manufacturer guidelines, and the device has received FDA 510(k) clearance under K-number K141527.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141527 | Date30 Mar 2015 | 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- Withdrawn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
- HRS
- FDA applicant
- Synthes USA
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Synthes (Usa)
Questions
What types of fractures in the hand is this system specifically designed to treat?
The Variable Angle Locking Hand System is designed for internal fixation of fractures in the hand, including both lateral and dorsal applications. It features fragment-specific plates tailored for fracture repair and deformity correction, allowing precise stabilization of complex hand injuries.
Is this system reusable, or is it intended for single-use only?
The system is supplied as non-sterile and is intended for either single-use or reusable application, depending on the specific component. Proper sterilization and handling procedures must be followed if reusing any part of the system.
What materials are the plates made from, and how many different plate types are included?
The plates in the Variable Angle Locking Hand System are made from either stainless steel or titanium. The system includes 40 different basic and specialty plates, providing versatility for various hand fracture repair and deformity correction procedures.
How should this device be stored, and is it sterile upon receipt?
The device is provided non-sterile and must be sterilized before use. Storage and handling should strictly follow the manufacturer’s guidelines to maintain integrity and ensure safety for surgical applications.
What regulatory pathway was followed for FDA clearance of this device?
The Variable Angle Locking Hand System received FDA 510(k) clearance under the traditional review pathway, with a clearance number of K141527. It was determined to be substantially equivalent to a predicate device and was reviewed by the Orthopedic (OR) Advisory Committee.