Maxx Libertas Bipolar Hip Head (Bipolar Hip)

Q: What is the product code of K243634?

The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.

FDA 510(k) K243634 · Maxx Orthopedics, Inc.

Substantially Equivalent

510(k) numberK243634

Submission

Device name: Maxx Libertas Bipolar Hip Head (Bipolar Hip)
Applicant: Maxx Orthopedics, Inc.
Norristown, PA, US
Received: November 25, 2024
Decision date: August 25, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3390
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code KWY

510(k)	Device	Applicant	Decision
K253357	b-ONE® Bipolar HeadKWY · Traditional	B-One Ortho, Corp.	04/13/2026SE
K231526	CORAIL Cemented Femoral StemKWY · Traditional	Depuy Ireland UC	12/19/2023SE
K223441	SpaceFlex Acetabular CupKWY · Traditional	G21, S.R.L.	03/23/2023SE
K221794	Vario-Cup SystemKWY · Special	Waldemar Link GmbH & Co. KG	07/20/2022SE
K220492	COPAL exchange G hip spacerKWY · Special	Heraeus Medical GmbH	03/23/2022SE
K200709	Kyocera Bipolar Hip SystemKWY · Special	Kyocera Medical Technologies, Inc.	04/17/2020SE
K192236	Fitmore Hip StemKWY · Special	Zimmer GmbH	11/05/2019SE
K191016	COPAL exchange G Hip and Knee SpacersKWY · Traditional	Heraeus Medical GmbH	11/01/2019SE
K191297	iNSitu Bipolar Hip SystemKWY · Traditional	Theken Companies, LLC	09/17/2019SE
K191569	Implantcast ic-Bipolar Head SystemKWY · Traditional	Implantcast GmbH	08/28/2019SE

More from Implantcast GmbH

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K253171	Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)LZO · Traditional	01/15/2026SE
K252777	Freedom Metaphyseal Cone Implants (Metaphyseal Cones)MBH · Traditional	10/31/2025SE
K253314	Freedom Infinia Total Knee SystemJWH · Special	10/29/2025SE
K253144	Freedom® Total Knee System Titan PCK ComponentsJWH · Special	10/22/2025SE
K251717	Freedom® Total Knee System Titanium Tibial Base PlateJWH · Special	06/26/2025SE
K250382	Freedom Total Knee System (All-poly Tibial Plate)JWH · Special	03/13/2025SE
K241597	Freedom® Total Knee System - Porous Tibial Base PlateMBH · Traditional	02/13/2025SE
K243277	Freedom® Medial Congruent LinerJWH · Special	11/19/2024SE

Questions and answers

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

Maxx Libertas Bipolar Hip Head (Bipolar Hip) (K243634) received a 510(k) decision of Substantially Equivalent on August 25, 2025, 273 days after the submission was received.

What is the product code of K243634?

The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.