Duration II Acetabular Components-Ethylene Oxide Sterilization

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K980926 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Howmedica(R) Fully Threaded Screws

  Class II

  FDA 510(k) K974720 Active Cleared 13 Mar 1998

• Alta Femoral Intramedullary Rods/Cfx Rods Modification

  Class II

  FDA 510(k) K935295 Active Cleared 11 Oct 1994

• Naso-Gard Nasogastric Tube Holder

  Class II

  FDA 510(k) K801511 Active Cleared 28 Jul 1980

• Class of Casting Alloys Type III or Alt

  Class II

  FDA 510(k) K820434 Active Cleared 11 Mar 1982

• Howmedica Zirconia Ceramic Femoral Head

  Class II

  FDA 510(k) K945090 Active Cleared 19 Jan 1995

• Extended Balljoint Grip

  Class II

  FDA 510(k) K802723 Active Cleared 19 Nov 1980

See all devices from Howmedica Corp. →

• What is the Duration II Acetabular Component used for?

  The Duration II Acetabular Component is a machined insert designed for use in primary or revision hip surgery, providing a hip replacement solution when mated with Osteolock/Vitalock acetabular shells and Howmedica femoral heads.

• How are the Duration II Acetabular Components supplied?

  The device is supplied as a sterile, single-use product that is terminally sterilized via ethylene oxide, ready for implantation by orthopedic surgeons.

• What regulatory status does the Duration II Acetabular Component have?

  The Duration II Acetabular Component is regulated under FDA 510(k) clearance with product code JDI and was determined to be substantially equivalent on December 16, 1998.

• Can the Duration II Acetabular Component be reused?

  No, the Duration II Acetabular Component is supplied as a single-use product and should not be reused for patient safety and regulatory compliance reasons.