# K010533: Biosling - Bioabsorbable Polymer Sling & Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Injectx, Inc.
- Decided: May 24, 2001 after 90 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.
94 later devices descend from it; 5 cite it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020110: Modification to Trelex Mesh Surgical Mesh (2002), 38 descendants of its own
- K050332: Surgi-Wrap Mast Bioresorbable Sheet (2005), 36 descendants of its own
- K041632: Minimesh Polypropylene Mesh (2004), 27 descendants of its own
- K020652: Herniamesh T-Sling (2002), 19 descendants of its own
- K070894: Tephaflex Surgical Mesh (2007), 17 descendants of its own

Source page: https://510kreport.com/device/K010533
Methodology: https://510kreport.com/methodology