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FDA 510(k)

Maxx Libertas Bipolar Hip Head (Bipolar Hip)

K-Number: K243634 · 2025-08-25

ApplicantMaxx Orthopedics, Inc.
Decision Date2025-08-25
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Maxx Libertas Bipolar Hip Head (Bipolar Hip) is a medical device manufactured by Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2025-08-25 under approval number K243634. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Maxx Libertas Bipolar Hip Head (Bipolar Hip)?

Maxx Libertas Bipolar Hip Head (Bipolar Hip) is a medical device that received FDA 510(k) clearance on 2025-08-25. It is manufactured by Maxx Orthopedics, Inc.. The 510(k) number is K243634.

When was Maxx Libertas Bipolar Hip Head (Bipolar Hip) approved by the FDA?

Maxx Libertas Bipolar Hip Head (Bipolar Hip) received FDA 510(k) clearance on 2025-08-25, under approval number K243634.

What company makes Maxx Libertas Bipolar Hip Head (Bipolar Hip)?

Maxx Libertas Bipolar Hip Head (Bipolar Hip) is manufactured by Maxx Orthopedics, Inc..

What is the FDA product code for Maxx Libertas Bipolar Hip Head (Bipolar Hip)?

The FDA product code for Maxx Libertas Bipolar Hip Head (Bipolar Hip) is KWY.

Other Devices by Maxx Orthopedics, Inc.

K180973Libertas Hip Replacement System K192148Freedom Primary PCK K183684Libertas – Taper Uncemented Femoral Stem K183365Libertas Acetabular Hooded Liner K182574Freedom Ultra-Congruent CR Tibial Liner K200912Freedom(R) - TiNbN Coated Knee

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Related Devices (Code: KWY)

K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation K170072Fitmore® Hip StemZimmer GmbH K173455SurgTech Bipolar Head SystemSurgtech, Inc. K180130ELEOS™ Bipolar Acetabular SystemOnkos Surgical, Inc. K16308140-42mm BiPolar Head and 22mm Femoral HeadSignature Orthopaedics Pty, Ltd. K192236Fitmore Hip StemZimmer GmbH

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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