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Press-Fit Head Resurfacing Device
Summary: The press-fit head resurfacing device by Biomet Orthopedics is used primarily in hip arthroplasty. Key evidence highlights its role in improving hip stability with large-diameter bearings, though initial press-fit stability can be challenging.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K023188 ↗
Decision Date ?
December 11, 2002
Product Code ?
KXA
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on December 11, 2002. Manufactured by Biomet Orthopedics, it is classified as a Class 2 medical device.
What It Is
The press-fit head resurfacing device is designed for hip arthroplasty, providing a bone-preserving alternative to total hip replacement. It utilizes a press-fit mechanism to secure the implant without cement, aiming to improve joint stability.
FDA-Cleared Indications
- Hip joint resurfacing arthroplasty for patients requiring treatment of a diseased or damaged hip joint.
Clinical Applications
- Femoral head resurfacing as part of hip arthroplasty.
- Treatment of selected patients with painful or functionally limiting hip joint disease when hip resurfacing is appropriate.
- Use with a compatible acetabular component in a hip resurfacing construct, according to the device labeling.
Evidence Summary
The literature includes 10 studies, ranging from case series to randomized controlled trials, published between 2018 and 2024. These studies explore various aspects of hip resurfacing, including fixation, wear rates, and bone changes.
Reported Outcomes
Published studies report that the device improves hip stability, particularly with large-diameter bearings. It is associated with lower wear rates in young, active patients, and may reduce dislocation risk compared to total hip replacement.
Safety Profile
Reported complications include challenges in achieving initial press-fit stability, metal debris-related issues, and potential metal hypersensitivity. These complications are primarily associated with metal-on-metal designs.
Evidence Limitations
The evidence is limited by the variability in study designs and the focus on specific patient populations. Further research is needed to explore long-term outcomes and the impact of different bearing materials.
Practical Considerations
- The implant must be matched with compatible components and selected in the appropriate size for the patient’s anatomy.
- Press-fit fixation depends on adequate bone quality, accurate preparation and stable initial seating; poor bone stock may make this approach unsuitable.
- The device is intended for use by orthopedic specialists with experience in hip resurfacing and the associated instrumentation.
- MRI safety and conditional-use information must be confirmed in the current manufacturer labeling; do not assume the implant is universally MRI safe.
- Contraindications and precautions may include infection, inadequate bone quality, severe bone loss, metal sensitivity and patient factors that increase the risk of implant failure.
Frequently Asked Questions
What are the clinical indications for the press-fit head resurfacing device?
The device is indicated for use in hip arthroplasty, particularly in patients with atypical acetabula requiring joint resurfacing.
What outcomes have been reported in clinical studies?
Studies report improved hip stability and reduced dislocation risk, with lower wear rates in young, active patients.
What complications have been reported?
Safety data indicate challenges with initial press-fit stability, metal debris issues, and potential metal hypersensitivity.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.