đź“‹ FDA Reference
Acufex Mosaicplasty Comprehensive System
Smith & Nephew Endoscopy
Summary: The Acufex Mosaicplasty Comprehensive System is a surgical toolset used for cartilage repair procedures, primarily by orthopedic surgeons. It facilitates the transplantation of osteochondral autografts to treat cartilage defects.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K964215 ↗
Decision Date ?
December 20, 1996
Product Code ?
HRX
Device Class ?
Class 2
Evidence ?
0 studies
The Acufex Mosaicplasty Comprehensive System was cleared through the FDA 510(k) pathway on December 20, 1996. It is manufactured by Smith & Nephew Endoscopy and classified as a Class 2 device.
What It Is
The Acufex Mosaicplasty Comprehensive System is a specialized surgical instrument set designed for mosaicplasty procedures, which involve transplanting small plugs of bone and cartilage to repair damaged cartilage surfaces. This system includes various tools that allow precise harvesting and implantation of osteochondral grafts. It is particularly useful in orthopedic surgeries aimed at restoring joint function and alleviating pain in patients with focal cartilage defects.
FDA-Cleared Indications
- Use in osteochondral autograft transplantation for repair of localized articular cartilage defects.
- Use to harvest and implant osteochondral plugs during mosaicplasty procedures.
Clinical Applications
- Harvesting osteochondral autograft plugs from a donor area of a joint.
- Preparing a recipient site for osteochondral plug implantation.
- Implanting multiple osteochondral plugs to restore a focal cartilage defect.
- Orthopedic treatment of appropriately selected focal articular cartilage defects, including defects treated in the knee.
Practical Considerations
- The surgeon selects instrument and graft dimensions based on the location, depth and size of the cartilage defect.
- The system is used with standard orthopedic arthroscopic or open surgical techniques; appropriate training in osteochondral autograft transplantation is required.
- Patient selection is important because extensive cartilage loss, diffuse arthritis, infection or inadequate donor cartilage may make mosaicplasty unsuitable.
- This is a surgical instrument system rather than an implanted device. MRI safety generally applies to any retained implants or hardware, not to the instruments after they are removed from the patient.
- Instrument compatibility, sterilization, inspection and handling should follow the current manufacturer instructions for use.
Frequently Asked Questions
What is the Acufex Mosaicplasty Comprehensive System used for?
It is used for performing mosaicplasty procedures to repair cartilage defects by transplanting osteochondral autografts.
What specialties typically use this device?
Orthopedic surgeons specializing in joint repair and cartilage restoration commonly use this device.
What are the FDA-cleared indications?
The device is indicated for treating cartilage defects through osteochondral autograft transplantation, aimed at restoring joint surfaces.
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.