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ACE Cancellous Bone Screw

by Buckman Co., Inc. 510(k)

Active United States

510(k) K882831

Overview

The ACE Cancellous Bone Screw is a cancellous bone screw designed for orthopedic applications. It is intended for use in bone fixation, providing secure attachment in spongy or cancellous bone structures, commonly used in orthopedic surgeries to stabilize fractures or facilitate bone healing.

This device is supplied as a reusable surgical instrument and is classified under product code HWC. It was granted FDA 510(k) clearance under a traditional review pathway by the Orthopedic (OR) Advisory Committee in 1988, with the clearance decision dated August 1, 1988. No specific sterility or MRI safety information is provided in the available data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK882831 Date1 Aug 1988ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What types of orthopedic procedures is the ACE Cancellous Bone Screw primarily used for?

    The ACE Cancellous Bone Screw is designed for bone fixation in spongy or cancellous bone, making it suitable for stabilizing fractures or aiding bone healing in orthopedic surgeries. Its structure ensures secure attachment in these types of bone tissues, which are common in procedures like internal fixation of long bone fractures or spinal stabilization.

  • Is the ACE Cancellous Bone Screw intended for single-use or can it be reused in multiple procedures?

    The ACE Cancellous Bone Screw is explicitly described as a reusable surgical instrument, meaning it is engineered for repeated use in clinical settings after proper cleaning and sterilization. This distinguishes it from single-use devices and aligns with its classification under product code HWC.

  • How was the FDA clearance for this device obtained, and what does that mean for its regulatory status?

    The ACE Cancellous Bone Screw received FDA clearance through a traditional 510(k) review pathway in 1988, with a decision dated August 1, 1988. The Orthopedic (OR) Advisory Committee reviewed it and determined it was substantially equivalent to a legally marketed predicate device. This means the FDA found it to have the same intended use and technological characteristics as an existing device, ensuring it meets regulatory standards for safety and effectiveness.

  • What address and contact details are available for inquiries about the ACE Cancellous Bone Screw?

    For inquiries, the manufacturer, Buckman Co., Inc., can be contacted at 921 Calle Verde, Martinez, CA 94553. The primary contact listed is David W Schlerf, though no additional contact methods (e.g., phone, email) are provided in the available data.