# K121306: Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device Handle

- Pathway: 510(k) (Traditional)
- Applicant: Arthocare Corporation
- Decided: Jul 12, 2012 after 72 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K030170 (2003). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023843: Smartstitch M-Connector, Model OM-8005; Smartstitch Actuation Handle, Model OM-8500; and Smartstitch Suture Cartridge, Opus Medical, Inc. (2003) Summary page 1.
- K033317: Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System Instrument Set, OM-9070, Opus Medical, Inc. (2003) Summary page 1.
- K062244: Opus Smartstich Suture Device with Perfectpasser Connector, Arthrocare Corp. (2006) Summary page 1.

## Most influential descendants
- K163142: SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader (2017), 0 descendants of its own

## Indications for use
The SmartStitch® M-Connector Ultra 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/K121306
Methodology: https://510kreport.com/methodology