PCA Modular Total Knee Tib Insert Durocon Baseplate

• 7 recalls, same reason

  • Ongoing Z-0913-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0909-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0908-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0912-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0911-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0910-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0907-2024 FDA Class II ·initiated 1 Dec 2023

  Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Full name

Pca(R) Modular Total Knee Tib Insert Durocon Baseplate

510(k) Number

K940861 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

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 PCA Modular Total Knee Tib Insert Durocon Baseplate used for?

  This device serves as a tibial insert component in total knee replacement surgeries. It is a semi-constrained patellofemorotibial knee prosthesis made of polymer/metal/polymer components designed for cemented use.

• How is the PCA Modular Total Knee Tib Insert Durocon Baseplate supplied?

  The device is supplied by Howmedica Corp. No information is provided regarding sterility, MRI safety, or storage conditions in the available data.

• Is the PCA Modular Total Knee Tib Insert Durocon Baseplate single-use or reusable?

  The device is not specified as single-use or reusable in the provided information. The classification details only indicate it is a Class II device with special controls under product code JWH.

• What is the regulatory status of the PCA Modular Total Knee Tib Insert Durocon Baseplate?

  The device received FDA 510(k) clearance on September 18, 1995 (K940861) and is classified as a Class II device with special controls. It was reviewed by the Orthopedic advisory committee.