COPAL exchange G Hip and Knee Spacers

Q: What is the product code of K191016?

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) K191016 · Heraeus Medical GmbH

Substantially Equivalent

510(k) numberK191016

Submission

Device name: COPAL exchange G Hip and Knee Spacers
Applicant: Heraeus Medical GmbH
Werheim, DE
Received: April 17, 2019
Decision date: November 1, 2019
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
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

510(k)	Device	Decision
K241674	Osteopal® VLOD · Traditional	12/05/2024SE
K234028	COPAL® exchange G hip spacer; COPAL® G+VKWL · Traditional	02/15/2024SE
K222570	COPAL knee mouldsJWH · Traditional	02/04/2023SE
K220492	COPAL exchange G hip spacerKWY · Special	03/23/2022SE
K213812	PALACOS MV proLOD · Traditional	02/02/2022SE
K210607	PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proLOD · Traditional	07/09/2021SE
K202475	PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GLOD · Traditional	11/23/2020SE
K190766	PALACOS fast R+GLOD · Traditional	05/31/2019SE
K182260	Palacos MVLOD · Special	09/17/2018SE
K153737	OSTEOPAL plusLOD · Special	04/22/2016SE

Questions and answers

When was COPAL exchange G Hip and Knee Spacers cleared by the FDA?

COPAL exchange G Hip and Knee Spacers (K191016) received a 510(k) decision of Substantially Equivalent on November 1, 2019, 198 days after the submission was received.

What is the product code of K191016?

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.