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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 ?
510(k)
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.
FDA-Cleared Indications
- Partial resurfacing of the humeral head.
- Treatment of selected defects involving the humeral head.
- Use in patients for whom treatment of the humeral head does not require complete shoulder arthroplasty.
Clinical Applications
- Partial resurfacing of a damaged humeral head.
- Treatment of selected humeral head defects associated with recurrent shoulder instability.
- Humeral-sided treatment during shoulder surgery when the glenoid and remaining shoulder structures do not require total shoulder arthroplasty.
- Bone-preserving reconstruction of the humeral head using an implanted resurfacing component.
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.
Practical Considerations
- The implant must be selected to match the patient's humeral head anatomy; available sizes and sizing methods depend on the manufacturer's current system documentation.
- It is intended for the humeral head and is not a complete replacement for the glenoid or a total shoulder arthroplasty system.
- Surgical placement requires preparation of the humeral head and accurate positioning to restore shoulder-joint mechanics.
- MRI safety and conditional-use requirements must be confirmed in the current device labeling and implant documentation before scanning.
- Contraindications and precautions may include infection, inadequate bone quality, severe bone loss, or shoulder conditions that require a different reconstruction; the operating surgeon determines suitability.
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.