# K053215: Surgical Mesh System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Jul 17, 2006 after 242 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.
13 later devices descend from it; 2 cite it directly.
0 of 14 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 no predicate by number.

## Most influential descendants
- K072370: Surgicraft Surgical Mesh System (2008), 11 descendants of its own
- K090288: Orthadapt PR (2009), 7 descendants of its own
- K112786: Proseries Bioimplants-Proankle/Procuff (2011), 5 descendants of its own
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own
- K251063: TekBrace Solo Soft Tissue Reinforcement Device (2025), 2 descendants of its own

## Indications for use
The Surgical Mesh System is intended to be implanted to reinforce soft tissue where weakness exists. The device is intended for one-time use.

Source page: https://510kreport.com/device/K053215
Methodology: https://510kreport.com/methodology