# K032093: Pariefix

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: Oct 22, 2003 after 107 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913469 (1991). 2 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913469: Endopath Disposable Endoscopic Multifeed Stapler, ETHICON, Inc. (1991) Summary page 1.
- K944415: Origin Tacker System, Origin Medsystems, Inc. (1994) Summary page 1.

## Most influential descendants
- K060494: Easytac Anchor.  Easytac Delivery System (2006), 14 descendants of its own
- K082396: Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 (2009), 13 descendants of its own
- K092483: Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018 (2009), 6 descendants of its own
- K132134: Optifix Absorbable Fixation System (2013), 4 descendants of its own
- K142873: OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners (2015), 3 descendants of its own

## Indications for use
The PARIEFIX Endoscopic Stapler is indicated for approximation of soft tissues and fixation of surgical mesh to tissues during laparoscopic surgical procedures such as hernia repair.

Source page: https://510kreport.com/device/K032093
Methodology: https://510kreport.com/methodology