DePuy Ace Trochanteric Side Plate
510(k) K970503
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970503 | Date30 Apr 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 22 Sep 2026
The DePuy Ace Trochanteric Side Plate is a side plate component used in conjunction with the DePuy Ace Captured Hip Screw Assembly. It is designed for use in osteotomies, arthrodeses, and hip fractures, including intertrochanteric, intracapsular, and subtrochanteric fractures.
The device is supplied as part of the DePuy Ace Captured Hip Screw System and features a proximal extension with three holes in a triangular configuration for fixation purposes. It is authorized under FDA 510(k) clearance with product code HRS and K number K970503.
Other devices from Depuy Ace Medical Co.
Questions
AI-generated answers, 22 Sep 2026
What is the DePuy Ace Trochanteric Side Plate used for?
The DePuy Ace Trochanteric Side Plate is designed for use in osteotomies, arthrodeses, and hip fractures, including intertrochanteric, intracapsular, and subtrochanteric fractures when used with the DePuy Ace Captured Hip Screw Assembly.
How is the DePuy Ace Trochanteric Side Plate supplied?
The device is supplied as part of the DePuy Ace Captured Hip Screw System and features a proximal extension with three holes in a triangular configuration for fixation purposes.
What is the regulatory status of the DePuy Ace Trochanteric Side Plate?
The DePuy Ace Trochanteric Side Plate is authorized under FDA 510(k) clearance with product code HRS and K number K970503, determined to be substantially equivalent to predicate devices.
Is the DePuy Ace Trochanteric Side Plate reusable or single-use?
The device data does not specify whether the DePuy Ace Trochanteric Side Plate is designed for single-use or multiple uses. This information would be available in the product's instructions for use provided by the manufacturer.