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Synthes Universal Locking Trochanter Stabilization Plate (ULTSP)

by Synthes (Usa) 510(k)

Active United States

510(k) K052677

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052677 Date12 Oct 2005ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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 Universal Locking Trochanter Stabilization Plate (ULTSP) is an orthopedic device designed to stabilize proximal femur fractures. It functions by combining with the DHS Plate and LCP DHHS Plate to prevent lateral displacement of greater trochanter fragments during impaction of the fracture zone, which helps to prevent medialization of the shaft relative to the head-neck fragment.

This device is used in conjunction with DHS and LCP systems for surgical stabilization of the proximal femur. It is authorized under FDA 510(k) clearance number K052677. The system includes components for securing the plate and implanting anti-rotation screws as part of the surgical technique.

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