Implex Ceramic Head

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

510(k) Number

K955117 ↗

FDA Product Code

LZO

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• The Trabecular Metal Technology Acetabular Augment System, Models 4893-Xx-Yy (Zimmer), 02-212-05XX1 ( Implex)

  Class II

  FDA 510(k) K012507 Active Cleared 30 Aug 2001

• Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1

  Class II

  FDA 510(k) K051196 Active Cleared 17 Jun 2005

• Hydrocel Vertebral Body Replacement, Model 06-172-00XX1

  Class II

  FDA 510(k) K022563 Active Cleared 30 Aug 2002

• Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution

  Class II

  FDA 510(k) K031449 Active Cleared 23 Sep 2003

• Implex Continuum Porous Patellar

  Class II

  FDA 510(k) K971789 Active Cleared 24 Jul 1997

• Implex Hep Acetabular Revision Cup, Cemented or Cementless Model A-240 System

  Class II

  FDA 510(k) K980486 Active Cleared 14 Apr 1998

See all devices from Implex Corp. →

• What types of hip surgeries is the Implex Ceramic Head designed for, and how does it fit into the procedure?

  The Implex Ceramic Head is specifically designed for total hip replacement surgeries, where it serves as the femoral head component. It is intended to articulate with a femoral stem and acetabular cup to restore hip joint function. This device supports both cemented and uncemented fixation methods, allowing surgeons to choose based on patient-specific needs and clinical judgment.

• Is the Implex Ceramic Head meant for reuse, or is it a single-use component?

  The Implex Ceramic Head is explicitly supplied as a single-use component, meaning it is intended for one surgical procedure only. This aligns with standard practices for orthopedic implants to ensure patient safety and sterility.

• What materials is the Implex Ceramic Head made from, and how does that affect its use?

  The Implex Ceramic Head is made from zirconia ceramic, a durable material chosen for its strength and biocompatibility in reconstructive hip surgeries. Its spherical shape and tapered bore allow it to articulate smoothly with the acetabular cup, providing stability and restoring joint function in patients with severe hip degeneration.

• How is the Implex Ceramic Head regulated, and what does that mean for its use in the U.S.?

  The Implex Ceramic Head is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K955117. This classification means it has been determined to be substantially equivalent to a legally marketed device already on the market, allowing it to be legally sold in the U.S. for its intended use in total hip replacement procedures.