# K090470: Autosuture Protack; Tacker System; Absorbatack Fixation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: May 14, 2009 after 80 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K951658 (1995). 6 ancestors in all.
12 later devices descend from it; 6 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963999: Auto Suture* Modified Endoscopic Fascia Stapler** Device, United States Surgical, A Division of Tyco Healthc (1996) Summary page 1.
- K944415: Origin Tacker System, Origin Medsystems, Inc. (1994) Summary page 1.
- K071920: Autosuture Absorbable Tack and Applicator, United States Surgical, A Division of Tyco Healthc (2007) Summary page 1.

## Most influential descendants
- K123109: Absorbatack 5MM Single Use Absorbable Fixation Device (2012), 4 descendants of its own
- K170278: OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners (2017), 1 descendant of its own
- K142808: CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners (2015), 1 descendant of its own
- K140609: Reliatack Articulating Reloadable Fixation Device with Standard Purchase Absorble Tacks (2014), 1 descendant of its own
- K110728: Imesh Tacker (2011), 1 descendant of its own

## Recalls of this device
- Nov 16, 2023 · Class II · Z-0986-2024: Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
- Feb 8, 2010 · Not classified · Z-1157-2010: Fixation device may fail to fire and staple.

## Indications for use
AutosutureTM Protack: The Auto SutureTM ProtackTM 5mm instrument has application in endoscopic surgery procedures for fixation of prosthetic material and approximation of tissue in various surgical specialties, such as the repair of hernial defects. AutosutureTM TACKER TM System: The Auto Suture TM TACKER TM System is indicated to affix prosthetic material or approximate tissue in a variety of endoscopic or other surgical procedures. Absorbatack T M Absorbable Fixation Devices: The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair.

Source page: https://510kreport.com/device/K090470
Methodology: https://510kreport.com/methodology