# K161638: SPEEDTRAP Graft Preparation System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Nov 7, 2016 after 146 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: 3 generations back to K010673 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040004: Orthocord Suture, Depuy Mitek (2004) Summary page 5.
- K043298: Blue Orthocord Suture, Depuy Mitek (2004) Summary page 5.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 5.

## Indications for use
The SPEEDTRAP suture construct is indicated for use in soft tissue approximation in orthopedic procedures.

Source page: https://510kreport.com/device/K161638
Methodology: https://510kreport.com/methodology