PCA Solid Back Acetabular Shell

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

Full name

Pca(R) Solid Back Acetabula Shell

510(k) Number

K930833 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Howmedica Corp. →

• What types of hip procedures is the PCA Solid Back Acetabular Shell designed for, and how does it differ from other acetabular components?

  The PCA Solid Back Acetabular Shell is specifically designed for total hip arthroplasty (replacement surgery) to replace the natural acetabulum. It is a semi-constrained, metal cemented acetabular component, meaning it relies on bone cement for fixation and offers moderate stability to the femoral head. This design helps restore hip function and mobility by ensuring proper articulation with the femoral component. Unlike unconstrained shells, it provides additional stability for patients who may need it, while still allowing for natural movement.

• Is the PCA Solid Back Acetabular Shell intended for single-use or can it be reused in multiple procedures?

  The PCA Solid Back Acetabular Shell is explicitly described as a reusable surgical implant. It is intended for use in orthopedic procedures within a sterile operating environment, meaning it can be sterilized and used in multiple surgeries, provided proper sterilization protocols are followed.

• What are the key features of the PCA Solid Back Acetabular Shell that make it suitable for cemented fixation?

  The PCA Solid Back Acetabular Shell is designed as a cemented acetabular component, meaning it relies on bone cement to bond directly to the patient’s pelvic bone. This feature provides a stable foundation for the femoral head to articulate with, ensuring long-term fixation and durability in total hip arthroplasty. The solid back design enhances structural support, reducing the risk of loosening or displacement over time.

• How many variants or sizes of the PCA Solid Back Acetabular Shell are available, and how are they identified?

  The PCA Solid Back Acetabular Shell comes in multiple variants, each identified by unique registration numbers (e.g., 8043792, 3020282716, etc.) and associated FEI numbers. These variants likely correspond to different sizes or configurations to accommodate varying patient anatomies. The product code JDL categorizes this device under FDA regulations, and the manufacturer, Howmedica Corp., would provide specific sizing details for surgical planning.

• What storage and handling considerations should be taken into account for the PCA Solid Back Acetabular Shell?

  Since the PCA Solid Back Acetabular Shell is reusable, it must be stored in a clean, dry environment to prevent contamination. Before use, it must undergo proper sterilization (e.g., autoclaving or ethylene oxide) to ensure sterility in the operating room. Additionally, it should be handled with sterile instruments and packaging to maintain its integrity and prevent cross-contamination between procedures.