# K063009: Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes)

- Pathway: 510(k) (Traditional)
- Applicant: Praesidia S.R.L.
- Decided: Dec 27, 2006 after 86 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K875156 (1988). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974016: Cerclage Cable with Hex Button, Pioneer Surgical Technology (1997) Summary page 1.
- K050041: Synthes (Usa) Sterile Sternal Fixation System, Synthes (Usa) (2005) Summary page 1.
- K030256: Iso-Elastic Cerclage System, Kinamed, Inc. (2003) Summary page 1.
- K983976: Metagen Activelock Wire Cerclage System, Metagen, LLC (1998) Summary page 1.
- (no number) Standard sternal wires: named in the summary without a submission number

## Most influential descendants
- K090686: Sic Brevetti S.R.L. Device for Sternal Synthesis (2009), 0 descendants of its own

## Indications for use
The Flexigrip Sternal Closure System is intended for use in closure or repair of the sternum after strenotomy, fracture or dehiscence.

Source page: https://510kreport.com/device/K063009
Methodology: https://510kreport.com/methodology