# K123268: Smartstitch Perfectpasser System

- Pathway: 510(k) (Special)
- Applicant: Arthocare Corporation
- Decided: Nov 7, 2012 after 19 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Feb 21, 2019 · Class II · Z-3000-2020: The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.

## Indications for use
The SmartStitch® PerfectPasser® System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.

Source page: https://510kreport.com/device/K123268
Methodology: https://510kreport.com/methodology