# K211007: EZ-TRAXTM Persona Knee Containment Device

- Pathway: 510(k) (Traditional)
- Applicant: K1 Medical, LLC
- Decided: Jul 1, 2021 after 90 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.
1 later device descends 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)
- K202270: EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device, K1 Medical, LLC (2020) Summary page 5.

## Most influential descendants
- 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™ Persona Knee Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Persona Knee devices between surgical uses. The EZ-TRAX™ Persona Knee 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 Temperature Exposure Time Drying Time Dynamic Air Removal 270 F/132 C 4 minutes 10 minutes Validations included the worst case load configurations of the EZ- TRAX™ Persona Knee Containment Devices. • Contents in the validated configuration include reusable surgical instruments (impactors, trials, cutting blocks, punches, ankle clamp, etc) • No lumened devices were validated within the tray system as part of the product load. The EZ- TRAX™ Persona Knee Containment Device does not have any lumen claims. • Healthcare facilities should not exceed 25 pounds (EZ-TRAXTM Containment Device + Sterile Barrier System + Persona Knee Devices). The EZ- TRAX™ Persona Knee Containment Device is offered in the following size: Brand Name Model Dimensions EZ-TRAX™ BASE.ASSY.AL.24.12.2.4 L) 22.97” (W) 11.18” (H) 2.44”

Source page: https://510kreport.com/device/K211007
Methodology: https://510kreport.com/methodology