GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive
by GPC Medical Limited India 510(k)
510(k) K210198 Product code HRS
Overview
This device is a Variable Angle Locking Plate System (HRS Product Code) designed for internal fixation of distal radius fractures. The plates feature anatomically contoured, two-column volar designs with variable-angle locking holes to accommodate complex fracture patterns, ensuring stable fixation across multiple screw trajectories.
The system includes 2.4mm plates with 6-hole and 7-hole configurations, a narrow 6-hole plate variant, and corresponding 2.4mm variable-angle locking screws with Stardrive compatibility. Supplied in sterile and non-sterile packaging, these devices are intended for use in orthopedic surgery under aseptic conditions. The plates are classified under the FDA’s Traditional 510(k) pathway (K210198) and are Substantially Equivalent to predicate devices, as reviewed by the Orthopaedic Devices Advisory Committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210198 | Date7 Jan 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from GPC Medical Limited
Questions
What types of distal radius fractures is this plate system designed to address, and how does the variable-angle feature help?
This system is designed for internal fixation of distal radius fractures, particularly complex patterns where stable fixation is critical. The anatomically contoured, two-column volar plates accommodate the natural shape of the distal radius, while the variable-angle locking holes allow screws to be placed at multiple trajectories. This flexibility ensures secure fixation across different fracture fragments, reducing the risk of hardware failure or displacement.
Are these plates available in sterile packaging, and if so, how should they be stored to maintain sterility?
Yes, the plates are supplied in both sterile and non-sterile packaging. For sterile versions, storage should follow the manufacturer’s instructions, typically in a clean, dry environment away from direct sunlight or extreme temperatures. The sterile barrier should remain intact until use to preserve sterility, and the device should be handled using aseptic techniques during surgery.
What screw sizes and compatibility features are included with these plates, and how does that affect surgical planning?
The system includes 2.4mm variable-angle locking screws designed for Stardrive compatibility, which means they can be driven using a specific driver system for precise placement. This ensures consistent screw engagement with the plate’s locking holes, improving fixation stability. The variable-angle feature allows surgeons to optimize screw trajectories based on fracture alignment, enhancing restoration of anatomical continuity.
How do the 6-hole, 7-hole, and narrow 6-hole plate variants differ, and which might be best for a specific fracture pattern?
The 6-hole and 7-hole plates offer extended fixation coverage for larger or more complex fractures, while the narrow 6-hole variant provides targeted support for smaller or more distal fractures where broader plates may not be necessary. The choice depends on the fracture’s location, displacement, and the surgeon’s assessment of stability needs. The two-column design ensures volar support regardless of variant, but the additional hole on the 7-hole plate may offer extra rigidity for comminuted fractures.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K210198