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FDA 510(k)

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

K-Number: K213209 · 2021-12-28

ApplicantK1 Medical, LLC
Decision Date2021-12-28
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is a medical device manufactured by K1 Medical, LLC. It received FDA 510(k) clearance on 2021-12-28 under approval number K213209. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device?

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is a medical device that received FDA 510(k) clearance on 2021-12-28. It is manufactured by K1 Medical, LLC. The 510(k) number is K213209.

When was EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device approved by the FDA?

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device received FDA 510(k) clearance on 2021-12-28, under approval number K213209.

What company makes EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device?

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is manufactured by K1 Medical, LLC.

What is the FDA product code for EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device?

The FDA product code for EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is KCT.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by K1 Medical, LLC

K192487EZ-TRAX Containment Device K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device K211007EZ-TRAXTM Persona Knee Containment Device

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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