# K163142: SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader

- Pathway: 510(k) (Special)
- Applicant: ArthroCare Corporation
- Decided: Jan 6, 2017 after 58 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
Longest line of descent: 3 generations back to K030170 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042031: Opus Speedstitch Suture Device, Opus Medical, Inc. (2004) Summary page 4.
- K121306: Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device Handle, Arthocare Corporation (2012) Summary page 4.

## Recalls of this device
- Aug 17, 2020 · Class II · Z-2999-2020: Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does no

## Indications for use
The SpeedStitch 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/K163142
Methodology: https://510kreport.com/methodology