# K163279: Medtronic Transportation/Sterilization Cassettes

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Feb 23, 2017 after 94 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: 7 generations back to K844002 (1984). 13 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152241: Medtronic Transportation/Sterilization Cassettes, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 4.

## Most influential descendants
- K173615: Stryker Universal Select Sterilization Tray System (2018), 2 descendants of its own
- K193066: Steripack cases and Tray Systems (2020), 0 descendants of its own
- 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 Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilization validations for the worst case Medtronic Transportation/Sterilization Cassette (22.75 x 11.26 x 5.5 inches) included implants and common surgical instruments such as rasps, drivers, trials, handles, inserters, probes, drills, etc. The validated total weight was 28.4lbs. The validated worst case loading configurations of the Medtronic Transportation/Sterilization Cassette included the following worst case lumen dimensions: - 363 x 1.575mm - 247.5 x 4.1mm

Source page: https://510kreport.com/device/K163279
Methodology: https://510kreport.com/methodology