Thompson Type Hip Prosthesis

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

Full name

Thompson Type Hip Prothesis

510(k) Number

K922868 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Replica Total Hip System

  Class II

  FDA 510(k) K951741 Active Cleared 7 Aug 1995

• Biometric Screw Fixation Cup

  Class III

  FDA 510(k) K922861 Active Cleared 12 May 1993

• Replica(Tm) Total Hip System

  Class II

  FDA 510(k) K926156 Active Cleared 9 Mar 1994

• Mueller Type Femoral Stem

  Class II

  FDA 510(k) K922864 Active Cleared 12 Feb 1993

• Oti European Compression System

  Class II

  FDA 510(k) K925571 Active Cleared 13 Jul 1993

• Neer Type Shoulder Prosthesis System

  Class II

  FDA 510(k) K922865 Active Cleared 10 Dec 1992

See all devices from Osteo Technology, Inc. →

• What types of patients is the Thompson Type Hip Prosthesis designed for, and how does its semi-constrained design benefit them?

  The Thompson Type Hip Prosthesis is designed for patients undergoing total hip arthroplasty who require replacement of a damaged acetabulum in the pelvis. Its semi-constrained metal design provides enhanced stability compared to fully unconstrained implants, which can be particularly beneficial for patients with moderate instability or those who need a balance between mobility and joint security. This design helps facilitate improved joint function while reducing the risk of dislocation.

• Is the Thompson Type Hip Prosthesis intended for cemented or uncemented placement, and what does this mean for surgical planning?

  The Thompson Type Hip Prosthesis is explicitly described as an uncemented acetabular component, meaning it is intended to be placed directly onto the prepared bone surface without the use of bone cement. This design requires careful surgical preparation of the acetabulum to ensure proper fit and osseointegration, which may influence preoperative planning, such as bone grafting or reaming techniques, to optimize long-term stability.

• How many variants or sizes of the Thompson Type Hip Prosthesis are available, and how are they identified?

  The Thompson Type Hip Prosthesis comes in multiple variants, each identified by unique FEI numbers (e.g., 3020282716, 1047843, etc.). These variants likely correspond to different sizes, shapes, or configurations of the acetabular component to accommodate varying patient anatomies and surgical needs. The exact dimensions or sizing details are not provided, but the availability of numerous FEI numbers suggests a range of options for customization during surgery.

• Is the Thompson Type Hip Prosthesis reusable or single-use, and what are the implications for surgical workflow?

  The Thompson Type Hip Prosthesis is explicitly described as a reusable medical implant, meaning it is intended for multiple uses within a surgical setting after proper cleaning, sterilization, and inspection. This design allows for cost efficiency in high-volume orthopedic procedures but requires adherence to strict reprocessing protocols to maintain safety and performance between cases, including sterilization validation and inventory tracking.

• What regulatory pathway was followed for FDA clearance of the Thompson Type Hip Prosthesis, and what does this mean for clinicians?

  The Thompson Type Hip Prosthesis received FDA clearance through a 510(k) submission (K922868), classified as substantially equivalent (SESE) to a predicate device under regulation number 888.3330. This means the device was determined to have the same intended use, technological characteristics, and performance as a previously cleared hip prosthesis. Clinicians can rely on this pathway as evidence of the device’s safety and effectiveness based on comparative historical data, though individual surgical outcomes may still vary based on patient-specific factors and technique.