Biolox Delta Ceramic Femoral Head

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

Full name

Consensus Biolox Delta Ceramic Femoral Head

510(k) Number

K110542 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Consensus® Hip System 0016-0-0001

  Class II

  GUDID on market

• Consensus Knee System

  Class II

  FDA 510(k) K102927 Active Cleared 26 Jan 2011

• PS2 Knee System

  Class II

  FDA 510(k) K160515 Active Cleared 19 Dec 2016

• Consensus Knee System Modular Tibial Baseplate

  Class II

  FDA 510(k) K143725 Active Cleared 4 Mar 2015

• Tahoe Uni Knee System

  Class II

  FDA 510(k) K170344 Active Cleared 5 Oct 2017

• Consensus CS2 Plus Acetabular Insert

  Class II

  FDA 510(k) K100933 Active Cleared 6 Oct 2010

See all devices from Consensus Orthopedics, Inc. →

• What types of hip conditions is the Biolox Delta Ceramic Femoral Head intended to address in total hip replacement surgeries?

  The Biolox Delta Ceramic Femoral Head is designed to replace the femoral head in total hip arthroplasty procedures, primarily to restore function and relieve pain caused by degenerative joint conditions such as osteoarthritis or severe arthritis. It is not intended for acute fractures or infections but rather for chronic joint deterioration where a durable, biocompatible replacement is needed.

• Is the Biolox Delta Ceramic Femoral Head reusable or single-use, and how is it sterilized before surgery?

  The Biolox Delta Ceramic Femoral Head is explicitly supplied as a single-use implant, meaning it is intended for one surgical procedure only. It is sterilized prior to use, adhering to strict manufacturing and quality control standards to ensure safety and reliability for clinical applications.

• What sizes are available for the Biolox Delta Ceramic Femoral Head, and how does this affect its compatibility with other components?

  The femoral head is available in standard sizes, though the exact range of sizes is not specified in the provided data. These sizes are designed to match common femoral head diameters used in total hip arthroplasty, ensuring compatibility with other orthopedic implants from the manufacturer. Compatibility should be confirmed with the surgical planning system or the manufacturer’s sizing guidelines.

• How is the Biolox Delta Ceramic Femoral Head regulated, and what does its FDA clearance status mean for clinicians?

  The Biolox Delta Ceramic Femoral Head is cleared under the FDA’s 510(k) pathway (K110542) as substantially equivalent to predicate devices like the Aesculap hip systems. This means it meets regulatory standards for safety and effectiveness as determined by the FDA, and it is classified as a Class II medical device, indicating moderate regulatory oversight. Clinicians can rely on this clearance as evidence of its compliance with U.S. medical device regulations.

• What storage requirements should be followed for the Biolox Delta Ceramic Femoral Head before surgical use?

  While specific storage instructions are not detailed in the provided data, as a sterile, single-use implant, the Biolox Delta Ceramic Femoral Head should be stored in its original packaging in a clean, dry environment protected from moisture, extreme temperatures, and physical damage. Always follow the manufacturer’s packaging guidelines to maintain sterility until immediate preoperative use.