# K183701: Stryker ChestShield Sterilization Tray System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Medical
- Decided: May 7, 2019 after 127 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: 9 generations back to K844002 (1984). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173615: Stryker Universal Select Sterilization Tray System, Paragon Medical (2018) Summary page 4.

## Indications for use
The Stryker ChestShield Sterilization Tray System is intended to organize, enclose, sterilize, transport, and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated, FDA cleared rigid sterilization container in order to maintain sterility of the enclosed devices. The Stryker ChestShield Sterilization Tray System has been validated for use in the following sterilization cycle: Pre-vacuum Steam Enclosure Rigid Container Temperature 132°C (270°F) Sterilization Time 4 minutes Minimum Dry Time 30 minutes Maximum Weight1 19.23 lb. / 8.72 kg 1 The validated load configuration for the Stryker ChestShield Sterilization Tray System included single-use implants (plates, bone screws, etc.), single-use instruments (drills), reusable surgical instruments (benders, forceps, drivers, etc.) and lumened instruments.

Source page: https://510kreport.com/device/K183701
Methodology: https://510kreport.com/methodology