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biocore9 humeral resurfacing system
Biocore9
Summary: The biocore9 humeral resurfacing system is designed for partial resurfacing of the humeral head. It is primarily used in cases of shoulder instability and humeral head defects. Key evidence highlights its role in reducing complications associated with traditional shoulder arthroplasty.
FDA Clearance Information
Pathway
510K
Number
K193122 ↗
Decision Date
May 15, 2020
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The biocore9 humeral resurfacing system was cleared by the FDA via the 510(k) pathway on May 15, 2020. It is manufactured by Biocore9 and classified as a Class 2 device under product code HSD.
What It Is
The biocore9 humeral resurfacing system is a medical device used for partial resurfacing of the humeral head. It is intended for patients with humeral head defects, providing a less invasive alternative to total shoulder arthroplasty.
Clinical Applications
This device is commonly used in clinical scenarios involving recurrent shoulder instability and humeral head defects. It offers a treatment option for patients who may not require full shoulder arthroplasty.
Evidence Summary
The available literature includes 10 peer-reviewed studies, primarily focusing on the outcomes and safety of humeral resurfacing. These studies span from 2016 to 2021, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the biocore9 humeral resurfacing system is effective in managing humeral head defects, with outcomes showing reduced complications compared to traditional shoulder arthroplasty. Patient satisfaction and implant longevity are noted as positive outcomes in several studies.
Safety Profile
Reported complications include risks associated with hardware, potential loss of motion, and the need for bone or soft tissue healing. However, the device is generally associated with a low incidence of severe complications.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up durations in some studies. Further research is needed to evaluate long-term outcomes and to compare the device directly with other treatment options.
Frequently Asked Questions
What are the clinical indications for biocore9 humeral resurfacing system?
The device is indicated for partial resurfacing of the humeral head in cases of shoulder instability and humeral head defects.
What outcomes have been reported in clinical studies?
Studies report reduced complications, high patient satisfaction, and good implant longevity compared to traditional shoulder arthroplasty.
What complications have been reported?
Safety data indicate risks such as hardware-related complications, loss of motion, and the need for bone or soft tissue healing.
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.