Consensus Total Hip System

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

Full name

Consensus(Tm) Total Hip System

510(k) Number

K922561 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 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 types of hip conditions is the Consensus Total Hip System designed to address?

  The Consensus Total Hip System is specifically designed to replace damaged or diseased hip joints, particularly in cases where natural joint function has been compromised. It is intended for use in total hip arthroplasty procedures to restore stability and function, particularly when semi-constrained metal acetabular components are required for cemented fixation.

• Is the Consensus Total Hip System reusable or single-use, and how should it be handled?

  The Consensus Total Hip System is a reusable orthopedic implant, meaning it is intended for multiple uses in sterile surgical settings. Since it is reusable, it must be thoroughly cleaned, sterilized, and inspected between procedures to ensure safety and functionality, following strict orthopedic sterile protocols.

• What regulatory pathway was followed for the FDA clearance of the Consensus Total Hip System?

  The Consensus Total Hip System received FDA clearance through the 510(k) pathway, specifically a Traditional review process. It was determined to be substantially equivalent to a legally marketed predicate device and is classified as a Class III medical device under regulation number 888.3320, indicating it carries higher regulatory scrutiny due to its critical role in orthopedic surgery.

• Are there multiple sizes or models available for the Consensus Total Hip System, and how would I identify them?

  The Consensus Total Hip System includes multiple acetabular component sizes and models, as indicated by the extensive list of registration numbers (e.g., 3020282716, 1047843, etc.) in the FDA database. These identifiers correspond to specific variants of the device, which should be cross-referenced with the manufacturer’s catalog or technical documentation to select the appropriate size for a patient’s anatomy and surgical needs.

• How should the Consensus Total Hip System be stored to maintain its integrity?

  Since the system is reusable and intended for surgical use, it must be stored in a clean, dry environment protected from contamination, moisture, and physical damage. The manufacturer’s guidelines should be followed for packaging and storage conditions, including any specific recommendations for sterilization cycles or shelf-life considerations to ensure the device remains safe and functional for repeated use.