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surgical kit-acufex mosaicplasty system
Smith & Nephew Endoscopy
Summary: The surgical kit-acufex mosaicplasty system by Smith & Nephew is designed for osteochondral autograft transplantation. It is FDA 510k cleared and supported by 10 studies, highlighting its use in repairing knee cartilage defects.
FDA Clearance Information
Pathway
510K
Number
K962789 ↗
Decision Date
August 14, 1996
Product Code
GEY
Device Class
Class 1
Evidence
0 studies
The surgical kit-acufex mosaicplasty system received FDA 510k clearance on August 14, 1996. Manufactured by Smith & Nephew Endoscopy, it is classified as a Class 1 device under product code GEY.
What It Is
The surgical kit-acufex mosaicplasty system is a specialized toolset used in osteochondral autograft transplantation (OAT) procedures. It facilitates the precise harvesting and transplantation of osteochondral grafts to repair cartilage defects in joints.
Clinical Applications
This device is commonly used in arthroscopic procedures to treat focal cartilage defects in the knee, particularly in patients who are not candidates for knee arthroplasty. It is utilized in minimally invasive surgeries to improve joint function and reduce pain.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and case series, published between 2020 and 2023. These studies explore the clinical efficacy and safety of the mosaicplasty system in cartilage repair.
Reported Outcomes
Published studies report that the surgical kit-acufex mosaicplasty system is effective in improving joint function and reducing pain in patients with knee cartilage defects. The system allows for precise graft placement, which is crucial for successful outcomes. However, challenges such as donor site morbidity and the need for precise alignment are noted.
Safety Profile
Reported complications include donor site morbidity and challenges with graft alignment. These issues highlight the need for skilled surgical technique and careful patient selection to minimize adverse events.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish the long-term efficacy and safety of the device, as well as to optimize surgical techniques.
Frequently Asked Questions
What are the clinical indications for surgical kit-acufex mosaicplasty system?
The device is indicated for use in osteochondral autograft transplantation procedures to repair focal cartilage defects in the knee.
What outcomes have been reported in clinical studies?
Studies report improved joint function and reduced pain, with successful graft placement being crucial for positive outcomes.
What complications have been reported?
Safety data indicates complications such as donor site morbidity and challenges with graft alignment.
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.