Delta Hip Prosthesis

Q: What is the product code of K961378?

The FDA product code is LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3360.

FDA 510(k) K961378 · Zimmer, Inc.

Substantially Equivalent

510(k) numberK961378

Submission

Device name: Delta Hip Prosthesis
Applicant: Zimmer, Inc.
Warsaw, IN, US
Received: April 10, 1996
Decision date: October 8, 1996
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3360
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code LWJ

510(k)	Device	Applicant	Decision
K120595	Unisyn Plus Hip StemLWJ · Traditional	Consensus Orthopedics, Inc.	10/12/2012SE
K103518	Trinity Acetabular SystemLWJ · Traditional	Corin USA	03/09/2011SE
K090764	Novation CFS Press-Fit and Cemented StemsLWJ · Special	Exactech, Inc.	04/21/2009SE
K082146	Metha Short Stem Hip System XL Femoral HeadLWJ · Special	Aesculap Implant Systems, Inc.	09/09/2008SE
K070061	36MM Cocr Femoral Head and 36MM Acetabular InsertLWJ · Special	Hayes Medical, Inc.	01/31/2007SE
K062978	U2 Hip Stem, Ti Plasma SprayLWJ · Traditional	United Orthopedic Corp.	01/16/2007SE
K062383	Unisyn Ha Plasma Modular HipLWJ · Special	Hayes Medical, Inc.	12/21/2006SE
K061699	ExciaLWJ · Special	Aesculap, Inc.	08/18/2006SE
K051826	Betacone Hip Prosthesis SystemLWJ · Traditional	Waldemar Link GmbH & Co. KG	11/18/2005SE
K050262	U2 Acetabular ComponentLWJ · Traditional	United Orthopedic Corp.	08/15/2005SE

More from United Orthopedic Corp.

510(k)	Device	Decision
K261683	Augment Off-Axis Instrument SystemPHX · Special	06/16/2026SE
K260831	Z1 Hip SystemLZO · Traditional	06/16/2026SE
K251840	Zimmer® Persona® Personalized Knee SystemMBH · Traditional	05/28/2026SE
K260182	Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional	04/27/2026SE
K253592	Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…MBF · Traditional	04/13/2026SE
K253566	Affixus Retrograde Femoral Nailing SystemHSB · Traditional	03/12/2026SE
K253189	Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional	03/09/2026SE
K252623	G7® Revision Acetabular SystemLPH · Traditional	02/04/2026SE
K251098	Identity Revision Humeral StemsMBF · Traditional	08/11/2025SE
K251906	Z1 Hip SystemLZO · Special	07/18/2025SE

Questions and answers

When was Delta Hip Prosthesis cleared by the FDA?

Delta Hip Prosthesis (K961378) received a 510(k) decision of Substantially Equivalent on October 8, 1996, 181 days after the submission was received.

What is the product code of K961378?

The FDA product code is LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3360.