Absorbable Foam Buttress
by J&J Corporate Biomaterials Center 510(k)
Active
510(k) K014183
Overview
The Absorbable Foam Buttress is a surgical mesh device classified as a polymeric surgical mesh, intended to reinforce tissue during anastomotic procedures. It provides structural support to areas where tissue integrity may be compromised, such as in gastrointestinal or vascular repairs. Constructed from an absorbable foam material, it integrates with biological tissue over time and degrades naturally without requiring removal.
Supplied as a sterile, single-use system, the Absorbable Foam Buttress consists of a cartridge and anvil carrier with attached buttressing material. It is integrated with endoscopic and open linear cutting/transecting staplers for precise tissue approximation and reinforcement. Regulated under FDA 510(k) clearance (K014183) and designated for general and plastic surgery applications, it must be stored and handled under sterile conditions to maintain its integrity.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK014183 | Date12 Jun 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Afb (Absorbable Foam Buttress)
- 510(k) Number
- FDA Product Code
- FTL
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Questions
What types of surgical procedures is the Absorbable Foam Buttress designed to support, and how does it integrate with existing tools?
The Absorbable Foam Buttress is designed to reinforce tissue during anastomotic procedures, particularly in gastrointestinal or vascular repairs where tissue integrity may be compromised. It is integrated with endoscopic and open linear cutting/transecting staplers, allowing for precise tissue approximation and reinforcement. This ensures the buttress can be placed accurately during stapling to provide structural support.
Is the Absorbable Foam Buttress intended for single-use only, and if so, why?
Yes, the Absorbable Foam Buttress is supplied as a sterile, single-use system. This is because it is designed to degrade naturally over time after integrating with biological tissue, and reusing it could compromise sterility, integrity, and patient safety. Single-use also aligns with its absorbable nature, ensuring it does not remain in the body long-term.
How should the Absorbable Foam Buttress be stored to maintain its integrity, and why is this important?
The Absorbable Foam Buttress must be stored and handled under sterile conditions to preserve its integrity. Since it is a sterile, single-use device, exposure to non-sterile environments could introduce contaminants, compromise its absorbable properties, or damage the material before use. Proper sterile storage ensures the device remains safe and effective for its intended surgical application.
What regulatory pathway was followed for the FDA clearance of the Absorbable Foam Buttress, and what does this mean for its use?
The Absorbable Foam Buttress received FDA clearance through a 510(k) pathway, specifically designated as *Substantially Equivalent* (SESE) under the General, Plastic Surgery advisory committee. This means the device was determined to be as safe and effective as a legally marketed predicate device, allowing it to be marketed for use in general and plastic surgery applications as described in its labeling. The clearance does not imply any specific clinical indication beyond its intended use in anastomotic reinforcement.
What is the composition of the Absorbable Foam Buttress, and how does this affect its function in the body?
The Absorbable Foam Buttress is constructed from an absorbable foam material, which is designed to integrate with biological tissue over time. Unlike permanent meshes, this material degrades naturally without requiring surgical removal, providing temporary structural support during tissue healing. Its absorbable nature ensures it eventually dissolves, reducing the risk of long-term complications.