# K213209: EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device

- Pathway: 510(k) (Traditional)
- Applicant: K1 Medical, LLC
- Decided: Dec 28, 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: 10 generations back to K844002 (1984). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211007: EZ-TRAXTM Persona Knee Containment Device, K1 Medical, LLC (2021) Summary page 5.

## Indications for use
The EZ-TRAX ™ Zimmer G7 Acetabular System I Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Zimmer G7 Acetabular System I Taperloc Complete Hip System devices between surgical uses. The EZ-TRAX ™ Zimmer G7 Acetabular System I Taperloc Complete Hip System 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.

Source page: https://510kreport.com/device/K213209
Methodology: https://510kreport.com/methodology