FPC/SFPC/RFPC Acetabular Component

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

510(k) Number

K915529 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Ufc Hip Stem Component

  Class II

  FDA 510(k) K924099 Active Cleared 30 Apr 1993

• Psk Posterior Stabilized Toatal Knee

  Class II

  FDA 510(k) K915798 Active Cleared 4 Mar 1993

• PPC Hip Stem Component

  Class II

  FDA 510(k) K915385 Active Cleared 17 May 1993

• Bhr Bipolar Femoral Head Component

  Class II

  FDA 510(k) K915528 Active Cleared 29 Jun 1993

• Crk Condylar Resurfacing Total Knee

  Class II

  FDA 510(k) K915584 Active Cleared 12 Feb 1993

• Fpc Hip Stem Component

  Class II

  FDA 510(k) K915391 Active Cleared 30 Apr 1993

See all devices from Implantology Corp. →

• What types of hip conditions is this acetabular component designed to address in surgical procedures?

  This FPC/SFPC/RFPC Acetabular Component is specifically designed for patients undergoing hip arthroplasty due to degenerative joint disease, fractures, or other conditions requiring replacement of the acetabular portion of the hip joint. It is intended to restore function and stability in these cases by serving as a metal cemented implant.

• Is this device single-use or reusable, and what are the sterilization requirements?

  The FPC/SFPC/RFPC Acetabular Component is a reusable surgical implant. Since it is intended for sterile operating environments, it must be handled and sterilized according to the manufacturer’s guidelines to ensure safety and efficacy before each use.

• How is this device regulated by the FDA, and what does the clearance status mean?

  This device holds an FDA 510(k) clearance (K915529) under the Traditional 510(k) Review pathway, with a decision date of July 13, 1993. The clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meaning it meets FDA standards for safety and effectiveness as a Class III medical device (regulated under 888.3320).

• Are there multiple sizes or models available for this acetabular component?

  While the provided data does not specify exact sizes or model variations in detail, the device is listed with multiple registration numbers (e.g., 3020282716, 3007923096, etc.), which may correspond to different sizes or configurations. Implantology Corp. likely offers a range of acetabular components to accommodate varying patient anatomies and surgical needs. For precise sizing options, refer to the manufacturer’s catalog or technical documentation.