Biometric Total Hip System
by Biomedics 510(k)
Active
510(k) K844787
Overview
The Biometric Total Hip System is a Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented (per FDA classification). It is designed as a replacement for the hip joint, providing structural support and restoring function in patients with degenerative joint disease, fractures, or other conditions requiring total hip arthroplasty. Constructed from metal and polymer materials, the system is intended for cemented fixation within the femoral shaft and acetabular components, ensuring stability and longevity in the treated joint.
This system is supplied as a modular orthopedic implant, comprising femoral and acetabular components, and is intended for use in surgical settings by trained orthopedic surgeons. It is classified as a Device Class II under FDA regulations and received FDA 510(k) clearance (K844787) in 1985 under the Traditional 510(k) Review Process. The device is not described as single-use or reusable in the available data, though its cemented design implies a permanent implant. No MRI safety or sterility specifications are provided in the submitted records.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844787 | Date19 Apr 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JDI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3350
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Biomedics
Questions
What conditions is the Biometric Total Hip System designed to treat?
The Biometric Total Hip System is specifically designed for patients requiring total hip arthroplasty due to degenerative joint disease, fractures, or other conditions causing severe hip joint dysfunction. It replaces the damaged joint to restore mobility, reduce pain, and provide long-term structural support by integrating with the existing bone via cemented fixation.
How is the Biometric Total Hip System supplied and what components does it include?
This system is supplied as a modular orthopedic implant kit, consisting of femoral and acetabular components. The modular design allows for customization during surgery to match the patient’s anatomy, ensuring a precise fit for stability and functionality. It is intended for use in surgical settings by trained orthopedic surgeons.
Is the Biometric Total Hip System intended for single-use or reusable applications?
The Biometric Total Hip System is not described as single-use or reusable in the available records. Given its cemented design and permanent implantation within the patient’s body, it is intended for one-time surgical use per patient. Reuse is not recommended due to the risk of contamination and compromise to sterility.
What materials are used in the construction of the Biometric Total Hip System?
The system is constructed from metal and polymer materials, combining durability with biocompatibility. The femoral and acetabular components are designed to integrate with bone cement for secure fixation, ensuring stability and longevity in the treated joint.
Are there any specific storage requirements for the Biometric Total Hip System?
The provided records do not specify detailed storage requirements for the Biometric Total Hip System. However, as with all orthopedic implants, it should be stored in a clean, dry environment protected from moisture, dust, and temperature extremes to maintain sterility and integrity until use. Follow manufacturer guidelines for packaging and handling to ensure optimal performance.