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DePuy Profile Round Head Interference Screw, DePuy Phantom Resorbable Interference Screw

by Depuy Orthopaedics, Inc.

510(k) K982662

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

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 NumberK982662 Date28 Oct 1998ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-1004-03 FDA Unclassified (pre-2012) initiated 16 Jun 2003 on shared 510(k) K982662

    Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20 mm may be a 7 X 25mm

    • Terminated Z-1005-03 FDA Unclassified (pre-2012) initiated 16 Jun 2003 on shared 510(k) K982662

    Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 X 25mm

    • Terminated Z-0699-03 FDA Unclassified (pre-2012) initiated 28 Feb 2003

    Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 20 mm

    • Terminated Z-0698-03 FDA Unclassified (pre-2012) initiated 28 Feb 2003

    Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 25 mm

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Profile Round Head Interference Screw and DePuy Phantom Resorbable Interference Screw are orthopedic devices consisting of cannulated, fully threaded cancellous bone screws. The Profile Round Head version is manufactured from titanium alloy, while the Phantom Resorbable version is manufactured from Poly-L-lactic acid. These screws are used in orthopedic procedures for ACL and PCL reconstruction to provide mechanical interference fixation of bone-patellar tendon-bone or soft tissue grafts to bone, facilitating graft stability during healing.

Supplied in diameters of 7, 8, and 9mm and lengths of 20, 25, and 30mm, the screws are intended for use by surgeons in clinical settings. The device received FDA 510(k) clearance under K982662 with product code HWC and was determined to be substantially equivalent to a predicate device. It is classified under the Orthopedic advisory committee (OR) and is authorized for marketing in the United States.

Other devices from Depuy Orthopaedics, Inc.

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Questions

AI-generated answers, 23 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 Profile Round Head Interference Screw and DePuy Phantom Resorbable Interference Screw used for?

    These screws are used in orthopedic procedures for ACL and PCL reconstruction to provide mechanical interference fixation of bone-patellar tendon-bone or soft tissue grafts to bone, facilitating graft stability during healing.

  • How are the DePuy Profile and Phantom interference screws supplied?

    The screws are supplied in diameters of 7, 8, and 9mm and lengths of 20, 25, and 30mm, intended for use by surgeons in clinical settings during orthopedic graft fixation procedures.

  • What materials are the DePuy Profile Round Head and Phantom Resorbable interference screws made from?

    The Profile Round Head version is manufactured from titanium alloy, while the Phantom Resorbable version is manufactured from Poly-L-lactic acid, a biodegradable polymer designed to absorb over time.