Skip to content

Ace Antegrade Retrograde Humeral Nail System

by Depuy Ace

510(k) K033878

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 NumberK033878 Date20 Feb 2004ClearedStatusActive

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  • Withdrawn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
HSB
Device Class
Class II
Regulation
21 CFR Part 888.3020
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 ACE Antegrade Retrograde Humeral Nail System is an intramedullary nail system intended for the fixation of humeral fractures. It includes an intramedullary nail, cancellous and cortical screws, and end caps. The nail features anterior/posterior and lateral/medial screw holes, distal and proximal bends, and a distal locking screw post.

The system is available in diameters of 7, 8, and 9 millimeters and various lengths in 20mm increments. It is used by surgeons in clinical settings to stabilize fractures and provide mechanical fixation. The device has received FDA 510(k) clearance with the product code HSB and authorization number K033878.

Other devices from Depuy Ace

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 ACE Antegrade Retrograde Humeral Nail System used for?

    The ACE Antegrade Retrograde Humeral Nail System is an intramedullary nail system designed for the fixation of humeral fractures. It includes an intramedullary nail, cancellous and cortical screws, and end caps to provide mechanical stabilization.

  • What sizes and configurations are available for this humeral nail system?

    The system is available in diameters of 7, 8, and 9 millimeters with various lengths in 20mm increments. It features anterior/posterior and lateral/medial screw holes, distal and proximal bends, and a distal locking screw post.

  • What is the regulatory status of the ACE Antegrade Retrograde Humeral Nail System?

    The device has received FDA 510(k) clearance with the product code HSB and authorization number K033878. It was determined to be substantially equivalent through the traditional clearance process.

  • How is the ACE Antegrade Retrograde Humeral Nail System supplied?

    The system is supplied as a complete intramedullary nail system that includes the nail itself, along with cancellous and cortical screws, and end caps. It is designed for use by surgeons in clinical settings for fracture stabilization.