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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
510K
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.
Clinical Applications
Commonly used in patients with medial tibiofemoral arthrosis, particularly active middle-aged individuals who have not responded to conservative treatments. It serves as an alternative to delay traditional joint replacement.
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.
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.