đź“Š Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For use in osteochondral autograft transplantation procedures.
- For harvesting and preparing osteochondral grafts for transfer to articular cartilage defects.
- Intended for orthopedic surgical use, including arthroscopic procedures, as specified by the device labeling.
Clinical Applications
- Harvesting cylindrical osteochondral plugs from a donor area of the joint.
- Preparing recipient sites for osteochondral graft implantation.
- Transplanting multiple osteochondral autografts in a mosaicplasty procedure.
- Repairing focal articular cartilage defects when osteochondral autograft transplantation is selected by the treating orthopedic surgeon.
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.
Practical Considerations
- The system is a manual surgical instrument kit; the surgeon selects graft diameter, number and placement according to the defect and available donor cartilage.
- It is used with compatible orthopedic surgical instruments and arthroscopic equipment; the specific configuration should be confirmed before the procedure.
- The system does not replace treatment decisions about nonoperative care, cartilage restoration alternatives, osteochondral allograft transplantation or arthroplasty.
- MRI safety depends on the individual instrument materials and whether any component remains in the patient. Instruments are removed after surgery, so patients should provide the implant or operative information before MRI if permanent hardware was also used.
- Contraindications and precautions depend on the procedure, patient anatomy, infection risk, bone quality, cartilage-defect characteristics and the device's current labeling.
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.