# K070671: Opus Smartstitch Suture Device

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Apr 6, 2007 after 25 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: 2 generations back to K030170 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062244: Opus Smartstich Suture Device with Perfectpasser Connector, Arthrocare Corp. (2006) Summary page 4.

## Recalls of this device
- Aug 8, 2011 · Not classified · Z-0612-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0613-2012: Product is being removed from the field due to an over-label issue.

## Indications for use
The Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector is indicated for use for placement of braided polyester and polyethylene suture through soft tissue in endoscopic and other limited access procedures.

Source page: https://510kreport.com/device/K070671
Methodology: https://510kreport.com/methodology