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nelson resurfacing head
Biomet
Summary: The Nelson Resurfacing Head by Biomet is a device used for femoral head resurfacing, primarily in cases of osteonecrosis. Key evidence indicates a success rate of 82% in patients without sickle cell disease.
FDA Clearance Information
Pathway
510K
Number
K983452 ↗
Decision Date
December 3, 1998
Product Code
KXA
Device Class
Class 2
Evidence
0 studies
The Nelson Resurfacing Head was cleared by the FDA via the 510(k) pathway on December 3, 1998. It is manufactured by Biomet and classified as a Class 2 device.
What It Is
The Nelson Resurfacing Head is a medical device designed for the resurfacing of the femoral head. It is used in orthopedic procedures to treat conditions such as osteonecrosis, aiming to preserve bone and delay the need for total hip replacement.
Clinical Applications
This device is commonly used in young patients with osteonecrosis of the femoral head, particularly those with collapse or delamination. It serves as an alternative to more invasive procedures like total hip arthroplasty.
Evidence Summary
The literature includes a mix of case series and retrospective studies, with a total of 5 studies reviewed. The studies span from 1992 to 2021, focusing on the efficacy and safety of femoral head resurfacing.
Reported Outcomes
Published studies report an 82% success rate in patients without sickle cell disease undergoing femoral head resurfacing with the Nelson Resurfacing Head. The average Harris Hip Score among successful cases was 87, with long-term follow-up showing an average score of 94.
Safety Profile
Reported complications include a 100% failure rate in patients with sickle cell disease or trait. No evidence of loosening or osteolysis was found in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of randomized controlled trials. Further research is needed to explore long-term outcomes and the device's efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Nelson Resurfacing Head?
The device is indicated for femoral head resurfacing in patients with osteonecrosis, particularly in young patients with head collapse or delamination.
What outcomes have been reported in clinical studies?
Studies report an 82% success rate in patients without sickle cell disease, with an average Harris Hip Score of 87.
What complications have been reported?
Safety data indicates a 100% failure rate in patients with sickle cell disease or trait, but no evidence of loosening or osteolysis.
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.