# K181933: DePuy Synthes Sterilization Container System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
- Decided: May 9, 2019 after 294 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K844652 (1984). 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)
- K130720: Synthes Reusable Sterilization Container System, Synthes (USA) Products, LLC (2014) Summary page 7.

## Indications for use
The DePuy Synthes Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by healthcare facilities. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days. The containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use.

Source page: https://510kreport.com/device/K181933
Methodology: https://510kreport.com/methodology