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DePuy Ace Trochanteric Side Plate

by Depuy Ace Medical Co.

510(k) K970503

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970503 Date30 Apr 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.