# K970561: Graft Patch

- Pathway: 510(k) (Traditional)
- Applicant: Organogenesis, Inc.
- Decided: Aug 1, 1997 after 169 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923657 (1992). 1 ancestor in all.
285 later devices descend from it; 5 cite it directly.
0 of 287 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923657: Supple Peri-Guard, Bio-Vascular, Inc. (1992) Summary page 2.

## Cited in the summary but kept off the family tree
- K810218: Prefilled Nebulizer, Corpak Co. (1981). Our OCR of the scanned summary read K810218, FDA’s number for Prefilled Nebulizer (Corpak Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Vicryl surgical mesh”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K980431: Surgisis (1998), 284 descendants of its own
- K992159: Surgisis Sling (1999), 204 descendants of its own
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant (2000), 173 descendants of its own
- K020049: Fortaflex Surgical Mesh (2002), 102 descendants of its own
- K034039: Sis Plastic Surgery Matrix (2004), 93 descendants of its own

## Indications for use
The GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

Source page: https://510kreport.com/device/K970561
Methodology: https://510kreport.com/methodology