Mark I & II Total Knee Replace. Sys

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

510(k) Number

K830726 ↗

FDA Product Code

MBV

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Freeman Hip

  Class II

  FDA 510(k) K852839 Active Cleared 29 Oct 1985

• Total Hip Femoral Component

  Class II

  FDA 510(k) K840150 Active Cleared 27 Feb 1984

• Mark I Total Knee Sys. Arthroplasty

  Class II

  FDA 510(k) K832302 Active Cleared 16 Aug 1983

• Yasargil Fenestrated Aneurysm Clip &

  Class II

  FDA 510(k) K833652 Active Cleared 27 Jan 1984

• PM Cementless Screw-In Acetabular Cup

  Class III

  FDA 510(k) K850773 Active Cleared 2 May 1985

• Cls Hip Prosthesis

  Class II

  FDA 510(k) K852517 Active Cleared 18 Sep 1985

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• What is the Mark I & II Total Knee Replacement System used for?

  The Mark I & II Total Knee Replacement System is designed for total knee arthroplasty procedures. It is a semi-constrained patello/femorotibial prosthesis made of UHMWPE, pegged, and cemented, constructed from polymer/metal/polymer components.

• Is the Mark I & II Total Knee Replacement System reusable?

  No, the Mark I & II Total Knee Replacement System is intended for single use only. It is supplied in various sizes but should not be reused on multiple patients.

• What regulatory status does the Mark I & II Total Knee Replacement System have?

  The Mark I & II Total Knee Replacement System has FDA 510(k) clearance with the product code MBV and regulation number 888.3560, classified as a Class II device. It is not indicated for MRI use.

• What materials are used in the Mark I & II Total Knee Replacement System?

  The Mark I & II Total Knee Replacement System is made of UHMWPE (ultra-high-molecular-weight polyethylene) and constructed from polymer/metal/polymer components. It is a semi-constrained, pegged, cemented prosthesis.