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Depuy DuPont Absorbable Set Screw

by Depuy, Inc. 510(k)

Active United States

510(k) K972494

Overview

The Depuy DuPont Absorbable Set Screw is a fully threaded, cannulated, headless cancellous bone screw designed for orthopedic fixation. It is classified under the nomenclature code HWC (Screw, Fixation, Bone) and is intended for use in bone-patellar-tendon-bone graft fixation during anterior cruciate ligament (ACL) reconstruction, providing early stabilization of the bone block.

This device is supplied as a single-use, sterile orthopedic implant and is regulated under FDA 510(k) clearance (K972494) with a Traditional review pathway. It features a blunt tip and is intended for use in orthopedic procedures, with no specific MRI safety or reusable specifications noted. The product was cleared in 1997 and remains classified as Class II – Special Controls under the Orthopedic advisory committee.

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 NumberK972494 Date1 Oct 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • 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 is the primary clinical use for the Depuy DuPont Absorbable Set Screw in orthopedic procedures?

    The Depuy DuPont Absorbable Set Screw is specifically designed for bone-patellar-tendon-bone graft fixation during anterior cruciate ligament (ACL) reconstruction. Its fully threaded, cannulated, and headless design provides early stabilization of the bone block, ensuring secure fixation in this procedure.

  • Is the Depuy DuPont Absorbable Set Screw intended for reuse, or is it meant for single-use only?

    The Depuy DuPont Absorbable Set Screw is explicitly supplied as a single-use, sterile orthopedic implant. This classification aligns with its absorbable material properties, which are intended to degrade over time, making reuse unsafe and unsuitable.

  • What regulatory pathway was followed for FDA clearance of this device, and when was it approved?

    The Depuy DuPont Absorbable Set Screw was cleared through the FDA’s 510(k) process under the Traditional review pathway, with a clearance number of K972494. It received its approval on October 1, 1997, and remains classified as a Class II device under the Orthopedic advisory committee’s special controls.

  • Does this screw have any special considerations for MRI safety, or is it intended for use in MRI environments?

    The provided data does not specify any particular MRI safety considerations for the Depuy DuPont Absorbable Set Screw. Since it is an orthopedic implant, clinicians should verify MRI safety based on the specific surgical context and imaging protocols, as absorbable materials may still pose risks in MRI environments.

  • What type of bone does the Depuy DuPont Absorbable Set Screw target, and why is it designed this way?

    The screw is designed for cancellous (spongy) bone fixation, which is common in ACL reconstruction procedures involving the patellar tendon. Its fully threaded, headless design ensures deep engagement in cancellous bone, providing stable fixation for the bone block while minimizing the risk of loosening.