Howmedica Alumina Femoral Head

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

510(k) Number

K915184 ↗

FDA Product Code

LZO

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Pfizer Hospital Products Group, Inc. →

• What types of hip replacement surgeries is the Howmedica Alumina Femoral Head designed for, and how is it fixed in place?

  The Howmedica Alumina Femoral Head is specifically designed for total hip arthroplasty procedures, where it serves as the femoral component of the prosthesis. It can be used with either cemented or non-porous/uncemented fixation methods, meaning it can be secured to the femur using bone cement or directly implanted without cement, depending on the surgeon’s preference and the patient’s clinical needs.

• Is this femoral head reusable or single-use, and how should it be handled to maintain sterility?

  The Howmedica Alumina Femoral Head is intended for reusable surgical use as a permanent implant. Since it is a sterile surgical implant, it must be handled, stored, and processed according to strict sterile surgical implant protocols to ensure no contamination occurs before, during, or after sterilization cycles. This includes proper packaging, sterilization validation, and adherence to facility-specific protocols for orthopedic implants.

• What materials is the femoral head made of, and how does it interact with the acetabular component?

  The femoral head is constructed from alumina ceramic, which articulates with a matching acetabular component (typically also ceramic or metal/polymer) to create a durable joint interface. This metal/ceramic/polymer combination is intended to reduce wear and friction, improving the longevity and performance of the hip prosthesis in total hip arthroplasty.

• What regulatory pathway was followed for FDA clearance of this device, and what class does it fall under?

  The Howmedica Alumina Femoral Head was cleared through the FDA 510(k) pathway with a traditional review process, specifically under Class II special controls for orthopedic applications. It was determined to be substantially equivalent to a predicate device and was reviewed by the Orthopedic (OR) Advisory Committee. The clearance numbers are K915184 and K945091, reflecting its regulatory history.