đź“Š Evidence-Based Reference
Unicap Unicompartmental Knee Resurfacing Prosthesis
Arthrosurface
Summary: The UniCAP unicompartmental knee resurfacing prosthesis is designed for knee joint resurfacing in patients with unicompartmental arthritis. Key evidence suggests it offers long-term treatment benefits for middle-aged patients.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K050373 ↗
Decision Date ?
October 11, 2005
Product Code ?
HSX
Device Class ?
Class 2
Evidence ?
0 studies
The UniCAP prosthesis was cleared by the FDA via the 510k pathway on October 11, 2005. Manufactured by Arthrosurface, it is classified as a Class 2 device under product code HSX.
What It Is
The UniCAP is a unicompartmental knee resurfacing prosthesis intended for patients with unicompartmental arthritis. It utilizes intraoperative, 3-dimensional joint surface mapping to fit and implant defect-sized components.
FDA-Cleared Indications
- Resurfacing of a damaged or arthritic area of the knee joint in patients with unicompartmental arthritis.
- Use in patients with disease limited primarily to one compartment of the knee who are appropriate candidates for partial knee resurfacing.
Clinical Applications
- Partial resurfacing of the medial tibiofemoral compartment of the knee.
- Treatment of localized femoral condyle cartilage and bone defects associated with unicompartmental arthrosis.
- Use in patients whose symptoms have not improved adequately with nonsurgical treatment.
- Implantation of a defect-sized component using intraoperative joint-surface preparation and sizing.
Evidence Summary
The available literature includes two studies published between 2014 and 2019. These studies encompass various designs, including retrospective and prospective analyses, focusing on the device's long-term outcomes and revision rates.
Reported Outcomes
Published studies report that the UniCAP prosthesis provides a long-term treatment option for middle-aged patients, with favorable outcomes in terms of revision and survival rates over a 9-year period. It is considered an effective alternative for managing unicompartmental arthritis.
Safety Profile
Reported complications include typical risks associated with knee resurfacing, though specific adverse events are not detailed in the provided studies. Further research is needed to comprehensively assess safety profiles.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety data. Further research is needed to validate long-term outcomes and safety across diverse patient populations.
Practical Considerations
- The implant is intended for a single knee compartment; disease involving multiple compartments may require a different treatment, such as total knee replacement.
- Component sizing and bone preparation are performed during surgery using the patient's joint-surface anatomy.
- The implant is placed through a surgical approach with anesthesia; it is not a catheter-based or percutaneous device.
- MRI safety depends on the specific implant materials and the conditions listed in the current device labeling. The implant card and manufacturer’s MRI information should be reviewed before scanning.
- Contraindications and precautions may include infection, inadequate bone quality, ligament instability, severe malalignment, or arthritis outside the treated compartment.
Frequently Asked Questions
What are the clinical indications for UniCAP?
The UniCAP is indicated for patients with unicompartmental arthritis, particularly those who have not responded to conservative treatments.
What outcomes have been reported in clinical studies?
Studies report favorable long-term outcomes, including low revision rates and effective management of unicompartmental arthritis.
What complications have been reported?
Specific complications are not detailed in the provided studies, indicating a need for further safety data.
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.