CPS Acetabular Component

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

510(k) Number

K915527 ↗

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

• FPC/SFPC/RFPC Acetabular Component

  Class III

  FDA 510(k) K915529 Active Cleared 13 Jul 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

See all devices from Implantology Corp. →

• What types of hip surgeries is the CPS Acetabular Component designed for, and how does its semi-constrained design benefit patients?

  The CPS Acetabular Component is specifically designed for use in total hip arthroplasty procedures where a metal acetabular cup is required. Its semi-constrained design provides a stable interface to support femoral components while allowing controlled movement, which can help reduce dislocation risks and improve joint stability for patients. This is particularly useful in cases where additional stability is needed beyond a conventional hip replacement.

• Is the CPS Acetabular Component reusable or intended for single-use, and how is it supplied?

  The CPS Acetabular Component is intended for single-use only in orthopedic surgical procedures. It is supplied sterile, ensuring it meets surgical standards without requiring additional sterilization in the operating room. This design aligns with best practices for orthopedic implants to minimize infection risks and ensure patient safety.

• How many sizes or variants of the CPS Acetabular Component are available, and how do I determine the correct size for a patient?

  The CPS Acetabular Component comes in multiple sizes and variants, as indicated by the listed registration numbers (e.g., 3020282716, 3007923096, etc.). The correct size is typically determined by preoperative imaging and measurements of the patient’s pelvic acetabulum, often guided by the surgeon’s assessment. Implantology Corp. provides sizing tools or references to assist in selection, ensuring proper fit and fixation during cemented placement.

• What storage requirements should be followed for the CPS Acetabular Component to maintain its sterility and integrity?

  The CPS Acetabular Component is supplied sterile, so it should be stored in its original, unopened packaging in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight. Follow the manufacturer’s instructions for shelf life and storage conditions, which are typically printed on the packaging. Avoid exposing the device to contaminants or physical damage before use to preserve sterility and functionality.

• What regulatory pathway was followed for FDA clearance of the CPS Acetabular Component, and how does this affect its use in clinical practice?

  The CPS Acetabular Component received FDA 510K clearance under the Traditional 510(k) Review pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously cleared device, ensuring it meets FDA safety and effectiveness standards. Clinically, this clearance confirms its compliance with U.S. regulations for use in total hip arthroplasty, though surgeons should always follow evidence-based protocols and manufacturer guidelines for optimal outcomes.