Bipolar Femoral Head

Q: What is the product code of K981238?

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) K981238 · Whiteside Biomechanics, Inc.

Substantially Equivalent

510(k) numberK981238

Submission

Device name: Bipolar Femoral Head
Applicant: Whiteside Biomechanics, Inc.
Creve Coeur, MO, US
Received: April 3, 1998
Decision date: August 21, 1998
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
K243634	Maxx Libertas Bipolar Hip Head (Bipolar Hip)KWY · Traditional	Maxx Orthopedics, Inc.	08/25/2025SE
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

More from Theken Companies, LLC

510(k)	Device	Decision
K033313	Quatro M Femoral ComponentLWJ · Traditional	07/28/2004SE
K012800	Symmetric Unicompartmental Knee SystemHRY · Traditional	05/03/2002SE
K003618	Whiteside Biomechanics Low Profile Stainless Steel Cable System, Model BIO-1-1014NDD · Traditional	05/23/2001SE
K993903	Whiteside Biomechanics Titanium Low-Profile Cable, Model BIO-1-1013JDQ · Traditional	02/14/2000SE
K991678	Whiteside Biomechanics Spinal SystemKWQ · Traditional	08/12/1999SE
K973261	Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral HeadLZO · Traditional	11/24/1997SE
K964616	Quatroloc Plasma Sprayed Femoral ComponentLPH · Traditional	08/07/1997SE
K971721	Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral HeadLZO · Traditional	07/30/1997SE
K971718	Micro-Seal Acetabular SystemLPH · Traditional	07/23/1997SE
K964150	Whiteside Biomechanics Zirconia Ceramic Femoral HeadLZO · Traditional	12/27/1996SE

Questions and answers

When was Bipolar Femoral Head cleared by the FDA?

Bipolar Femoral Head (K981238) received a 510(k) decision of Substantially Equivalent on August 21, 1998, 140 days after the submission was received.

What is the product code of K981238?

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.