Consensus Hip System- Porous Coated Titianium Femoral Stem

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

510(k) Number

K935193 ↗

FDA Product Code

LZO

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SN

• Consensus Zirconia Femoral Head

  Class II

  FDA 510(k) K955386 Active Cleared 20 Feb 1996

• Consensus Acetabular Shell, All Uhmwpe

  Class II

  FDA 510(k) K960302 Active Cleared 1 Apr 1996

• Consensus(Tm) Knee Cobalt Chrome Nonporous Stemmed Tibial Baseplate

  Class II

  FDA 510(k) K945589 Active Cleared 31 May 1995

• Consensus(Tm) Patella Reamer

  Class I

  FDA 510(k) K946197 Active Cleared 5 Apr 1995

• Consensus(Tm) Hip System-Ha Coated Tianium Fem Stem

  Class II

  FDA 510(k) K935453 Active Cleared 13 Jul 1994

• Consensus Posterior Stabilized Knee

  Class II

  FDA 510(k) K954818 Active Cleared 22 May 1996

See all devices from U.S. Medical Products, Inc. →

• What is the Consensus Hip System - Porous Coated Titanium Femoral Stem used for?

  This is an orthopedic device used in hip replacement procedures. It is a femoral stem component with a porous coated titanium surface designed for implantation into the femur to help restore hip function.

• How is the Consensus Hip System supplied and is it reusable?

  The device is supplied as a single-use implant, meaning it is designed for one patient only and should not be reused or resterilized. It comes in various sizes and models as specified by the manufacturer, U.S. Medical Products, Inc.

• What is the regulatory status of the Consensus Hip System?

  This device is regulated under FDA 510K clearance with product code LZO. It received FDA clearance on August 18, 1994, and is considered substantially equivalent for some indications as determined by the Orthopedic advisory committee.

• Where can I find more information about the manufacturer?

  The manufacturer is U.S. Medical Products, Inc., located at 912 S. Capital Of Texas Hwy., Suite 100, Austin, TX 78746. For specific inquiries, you can contact STEVEN I WHITLOCK.