# K202270: EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device

- Pathway: 510(k) (Traditional)
- Applicant: K1 Medical, LLC
- Decided: Dec 2, 2020 after 113 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; 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)
- K192487: EZ-TRAX Containment Device, K1 Medical, LLC (2019) Summary page 4.

## Most influential descendants
- 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™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon 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. Cycle: Dynamic Air Removal Temperature: 270 F/132 C Exposure Time: 4 minutes Drying Time: 10 minutes Sterilization validations included the worst case load configurations of the EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device utilized the Stryker Mako Total Knee with Triathlon Devices required to perform an arthroplasty procedure. Contents in the validated configuration include: reusable surgical instruments (impactors, trials, , MICS, sagital saws,.arrays, etc.) No lumened devices were validated within the tray system as part of the product load. The EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device does not have any lumen claims Healthcare facilities should not exceed 25 pounds (EZ- TRAX™ Containment Device + sterile barrier system + Stryker Mako Total Knee with Triathlon Containment devices). The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is offered in the following sizes: Brand Name Model Dimensions EZ-TRAX™ BASE.ASSY.AL.24.12.2.4 L) 22.97” (W) 11.18” (H) 2.44” EZ-TRAX™ BASE.ASSY.AL.21.12.4 (L) 19.97” (W) 11.18” (H) 4.187”

Source page: https://510kreport.com/device/K202270
Methodology: https://510kreport.com/methodology