Howmedica Bipolar Prosthesis

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

510(k) Number

K855231 ↗

FDA Product Code

KWY

Device Class

Class II

Regulation

21 CFR Part 888.3390

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 primary purpose of the Howmedica Bipolar Prosthesis in hip surgery?

  The Howmedica Bipolar Prosthesis is designed to replace or augment the femoral head during hip hemi-arthroplasty. Its bipolar design allows the femoral head to articulate with a separate acetabular component, which helps reduce wear on the primary bearing surface compared to traditional single-component implants. This design is particularly useful in cases where preserving joint motion while minimizing wear is critical.

• Is the Howmedica Bipolar Prosthesis intended for cemented or uncemented fixation, and how should it be used?

  The prosthesis is engineered for flexibility in surgical technique—it can be used with either cemented or uncemented fixation, depending on the clinical requirements and surgeon preference. The choice between cemented and uncemented fixation is determined by factors such as patient bone quality, age, and overall health, rather than a restriction imposed by the device itself.

• How is the Howmedica Bipolar Prosthesis supplied, and what precautions should be taken during storage?

  The device is supplied as a sterile, single-use implant, meaning it is intended for one surgical procedure only. To maintain sterility and integrity before use, it must be stored and handled according to standard orthopedic implant protocols. This typically includes keeping the packaging sealed, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions.

• What materials are used in the construction of the Howmedica Bipolar Prosthesis, and how does this affect its function?

  The prosthesis is constructed from metal and polymer materials, combining durability with the ability to articulate smoothly. The metal component provides structural integrity and load-bearing capacity, while the polymer likely contributes to the bearing surface’s wear resistance and smooth articulation between the femoral head and acetabular component, reducing friction and extending the longevity of the implant.

• How is the regulatory status of the Howmedica Bipolar Prosthesis determined, and what does this mean for clinicians?

  The device holds FDA 510(k) clearance under the product code KWY, classified as Class II with special controls. This means it has undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets applicable safety and performance standards. Clinicians can rely on this clearance as evidence that the prosthesis has been evaluated for its intended use in hip hemi-arthroplasty, though individual surgical decisions should still align with clinical guidelines and patient-specific factors.