đź“‹ FDA Reference
biodesign sling biodesign plastic surgery matrix biodesign anal fistula plug
Cook Biotech
Summary: The Biodesign Sling and Matrix by Cook Biotech are medical devices used in reconstructive surgeries, including plastic and colorectal procedures. They are typically utilized by surgeons in these specialties to support tissue repair and healing.
FDA Clearance Information
Pathway
510K
Number
K161221 ↗
Decision Date
May 26, 2016
Product Code
FTM
Device Class
Class 2
Evidence
0 studies
The Biodesign Sling and Matrix received FDA clearance via the 510(k) pathway on May 26, 2016. Manufactured by Cook Biotech, these devices are classified as Class II under product code FTM.
What It Is
The Biodesign Sling and Matrix are bioengineered devices designed to aid in tissue repair and regeneration. They are composed of biologically derived materials that integrate with the patient's tissue, promoting natural healing processes. These devices are used in various surgical applications to provide structural support and facilitate tissue reconstruction.
Clinical Applications
Commonly used in plastic and reconstructive surgery, the Biodesign Sling and Matrix are employed in procedures requiring soft tissue support, such as breast reconstruction or abdominal wall repair. In colorectal surgery, the Biodesign Anal Fistula Plug is used to treat anal fistulas by providing a scaffold for tissue growth, helping to close the fistula tract. These devices are suitable for use in both inpatient and outpatient surgical settings.
Indications for Use
The FDA indications for these devices include their use in surgeries where tissue reinforcement is needed. This includes patients undergoing reconstructive procedures or those with conditions like anal fistulas that require tissue support for healing.
Practical Considerations
The Biodesign devices come in various sizes to accommodate different surgical needs and anatomical variations. They are compatible with standard surgical techniques and instruments, making them versatile for use in multiple procedures. Surgeons should be familiar with the handling and placement techniques specific to these devices for optimal outcomes.
Frequently Asked Questions
What is Biodesign Sling & Matrix used for?
These devices are used for tissue reinforcement and regeneration in reconstructive surgeries, including plastic and colorectal procedures.
What specialties typically use this device?
Plastic surgeons and colorectal surgeons commonly use these devices in their respective reconstructive and repair procedures.
What are the FDA-cleared indications?
The devices are indicated for use in surgeries requiring tissue support and reinforcement, such as reconstructive and repair procedures.
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.