# K173615: Stryker Universal Select Sterilization Tray System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Medical
- Decided: Apr 18, 2018 after 147 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: 8 generations back to K844002 (1984). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163279: Medtronic Transportation/Sterilization Cassettes, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 5.

## Most influential descendants
- K181845: Pivot System Sterilization case (2019), 0 descendants of its own
- K183701: Stryker ChestShield Sterilization Tray System (2019), 0 descendants of its own

## Indications for use
The Stryker Universal Select 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 Universal Select Sterilization Tray System has been validated for use in the following sterilization cycles: Pre-vacuum Steam Enclosure Rigid Container Rigid Container Temperature 132°C (270°F) 135°C (275°F) Sterilization Time 4 minutes 3 minutes Minimum Dry Time 30 minutes 30 minutes Maximum Weight 25 lbs / 11.36 kg 25 lbs / 11.36 kg The maximum validated product loads for the trays in containers are as follows: Configuration Maximum Validated Load Set Contents 3-Level Rack – Qty. 2 (29-13910) in a Full DIN Rigid Sterilization Container 29-12900 1.2 Upper-Face Plates/Screws Module with Lid (29-13941) 29-12901 1.2 Orbital Plates/Mesh Module with Lid (29-13941) 29-17900 1.7 Mid-Face Plates/Screws Module with Lid (29-13941) 29-17901 1.7 Mid-Face Plates Module with Lid (29-13941) 29-17903 1.7 Orthognathic Plates Inlay 29-13901 Upper-/Mid-Face Instrument Tray with Lid (29-13921) 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921) 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941) 29-23901 2.0/2.3 Mandible Plates Module with Lid (29-13941) 29-23905 2.0/2.3 Mini Plates Inlay, Large 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921) 29-13905 Trocar Instrument Tray with Lid (29-13921) 3-Level Rack – Qty. 1 (29-13910) in a ½ DIN Rigid Sterilization Container 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941) 29-23903 2.0/2.3 Mandible Recon Plates Module with Lid (29-13941) 29-23904 2.0/2.3 Mandible Recon Primary Plates Inlay 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921) 29-13905 Trocar Instrument Tray with Lid (29-13921) 29-13906 Mandible Reconstruction Instrument Tray with Lid (29-13921) 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921)

Source page: https://510kreport.com/device/K173615
Methodology: https://510kreport.com/methodology