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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
510K
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.
Clinical Applications
This device is commonly used in orthopedic settings, particularly in procedures addressing knee cartilage defects. It is suitable for use in both hospital and outpatient surgical centers. The primary patient population includes individuals with localized cartilage damage due to trauma or degenerative conditions, often young to middle-aged adults who are active and seek to maintain joint function.
Indications for Use
The FDA-cleared indications for this device involve the treatment of cartilage defects through osteochondral autograft transplantation. It is intended for patients with specific areas of cartilage damage, where the goal is to restore the joint surface and improve mobility.
Practical Considerations
When using the Acufex Mosaicplasty Comprehensive System, surgeons should consider the size of the cartilage defect to determine the appropriate graft size. Compatibility with existing surgical tools and techniques is generally high, but familiarity with mosaicplasty procedures is essential for optimal outcomes.
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.