# K072370: Surgicraft Surgical Mesh System

- Pathway: 510(k) (Traditional)
- Applicant: Surgicraft, Ltd.
- Decided: Jul 24, 2008 after 336 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: 9 generations back to K921895 (1992). 50 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053215: Surgical Mesh System, Nuvasive, Inc. (2006) Summary page 1.
- K070961: Biomerix Surgical Mesh, Model: RCR-01, Biomerix Corporation (2008). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- 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
- K211563: Pitch-Patchs (2021), 2 descendants of its own

## Indications for use
The Surgcmft Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuffrepair surgery. The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.

Source page: https://510kreport.com/device/K072370
Methodology: https://510kreport.com/methodology