# K192487: EZ-TRAX Containment Device

- Pathway: 510(k) (Traditional)
- Applicant: K1 Medical, LLC
- Decided: Dec 23, 2019 after 103 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.
3 later devices descend from it; 1 cites 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)
- K152241: Medtronic Transportation/Sterilization Cassettes, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 5.

## Most influential descendants
- K202270: EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device (2020), 2 descendants of its own
- K211007: EZ-TRAXTM Persona Knee Containment Device (2021), 1 descendant of its own
- K213209: EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device (2021), 0 descendants of its own

## Indications for use
The EZ-TRAX™ Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store medical devices between surgical and other medical uses. The EZ-TRAX™ Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system. Validated Cycle Times for Dynamic Air Removal Steam Sterilization Cycles Cycle Temperature Exposure Time Drying Time Dynamic Air 10 minutes 270° F/ 132° C 4 minutes Removal Sterilization validations included a worst case EZ-TRAX™ Containment Device and a medical device challenge set comprising of: - Lumen dimensions (3) 1mm x 500mm - Conjoined/mated surfaces: forceps, clamps, bending pliers, ratchet handles, retractors - Cannulated: drill bits, taps, guides, screwdrivers, cannulated screws - A total weight of 42 lbs comprising of (EZ-TRAX™ Containment Device + sterile barrier system + medical device load) as a worst case challenge to the system. Healthcare facilities should not exceed 25 pounds (EZ-TRAX™ Containment Device + sterile barrier system + medical device load). The EZ-TRAX™ is offered in the following sizes: Brand Name Model Dimensions EZ-TRAX™ BASE.ASSY.AL.24.12.2 (L) 22.97” (W) 11.18” (H) 2.04” EZ-TRAX™ BASE.ASSY.AL.24.12.2.4 (L) 22.97” (W) 11.18” (H) 2.44”

Source page: https://510kreport.com/device/K192487
Methodology: https://510kreport.com/methodology