CoreHip® System

Q: When was CoreHip® System cleared by the FDA?

CoreHip® System (K172235) received a 510(k) decision of Substantially Equivalent on March 28, 2018, 246 days after the submission was received.

Q: What is the product code of K172235?

The FDA product code is LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3353.

FDA 510(k) K172235 · Aesculap Implants Systems, LLC

Substantially Equivalent

510(k) numberK172235

Submission

Device name: CoreHip® System
Applicant: Aesculap Implants Systems, LLC
Center Valley, PA, US
Received: July 25, 2017
Decision date: March 28, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3353
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code LZO

510(k)	Device	Applicant	Decision
K253948	Momentum Acetabular Cup SystemLZO · Traditional	United Orthopedic Corporation	09/02/2026SE
K261009	MobileLink Acetabular Cup System 40mm ID Inserts (various)LZO · Traditional	Waldemar Link GmbH & Co. KG	07/06/2026SE
K260831	Z1 Hip SystemLZO · Traditional	Zimmer, Inc.	06/16/2026SE
K260182	Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional	Zimmer, Inc.	04/27/2026SE
K260037	implantcast Packaging System UpdateLZO · Traditional	Implantcast GmbH	03/30/2026SE
K252401	implaFit® short stemsLZO · Traditional	Implantcast GmbH	03/12/2026SE
K253171	Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)LZO · Traditional	Maxx Orthopedics, Inc.	01/15/2026SE
K250450	Coated hip implantsLZO · Traditional	Medacta International S.A.	09/19/2025SE
K243021	Longboard Revision Hip StemLZO · Traditional	Signature Orthopaedics Pty, Ltd.	08/07/2025SE
K251906	Z1 Hip SystemLZO · Special	Zimmer, Inc.	07/18/2025SE

More from Zimmer, Inc.

510(k)	Device	Decision
K231769	activL® Next Generation InstrumentationQLQ · Special	07/13/2023SE
K172032	Modulift Vertebral Body Replacement (VBR) SystemPLR · Traditional	11/20/2017SE
K143443	VEGA Knee System, Columbus Total Knee SystemJWH · Special	03/25/2015SE

Questions and answers

When was CoreHip® System cleared by the FDA?

CoreHip® System (K172235) received a 510(k) decision of Substantially Equivalent on March 28, 2018, 246 days after the submission was received.

What is the product code of K172235?

The FDA product code is LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3353.