# K012025: Macropore Surgiwrap (TS)

- Pathway: 510(k) (Traditional)
- Applicant: Macropore Biosurgery, Inc.
- Decided: Dec 3, 2001 after 158 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
No predicates in its family tree.
83 later devices descend from it; 5 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SupraFOIL: named in the summary without a submission number
- (no number) Dexon: named in the summary without a submission number
- (no number) Biosling: named in the summary without a submission number
- (no number) Vicryl Mesh: named in the summary without a submission number
- (no number) Vipro Mesh: named in the summary without a submission number

## Most influential descendants
- K031955: Macropore Surgi-Wrap Mast Bioresorbable Sheet (2003), 76 descendants of its own
- K050332: Surgi-Wrap Mast Bioresorbable Sheet (2005), 36 descendants of its own
- K042811: Vivosorb Sheet, Model FS01 (2004), 22 descendants of its own
- K062558: Mesosfol Surgical Film (2007), 21 descendants of its own
- K090160: Suprathel Wound and Burn Dressing (2009), 18 descendants of its own

## Indications for use
The MacroPore Surgi-Wrap (TS) is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.

Source page: https://510kreport.com/device/K012025
Methodology: https://510kreport.com/methodology