PROFIX POSTERIOR-STABILIZED KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

SMITH & NEPHEW RICHARDS, INC.

The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Profix Posterior-stabilized Knee System.

Pre-market Notification Details

• Device ID: K954909
• 510k Number: K954909
• Device Name: PROFIX POSTERIOR-STABILIZED KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Thomas L Craig
• Correspondent: Thomas L Craig; SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-10-25
• Decision Date: 1996-01-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03596010222237	K954909	000
03596010222039	K954909	000
03596010222022	K954909	000
03596010221964	K954909	000
03596010221957	K954909	000
03596010221940	K954909	000
03596010221933	K954909	000
03596010221926	K954909	000
03596010221919	K954909	000
03596010221872	K954909	000
03596010221865	K954909	000
03596010221858	K954909	000
03596010222046	K954909	000
03596010222053	K954909	000
03596010222220	K954909	000
03596010222213	K954909	000
03596010222206	K954909	000
03596010222190	K954909	000
03596010222183	K954909	000
03596010222145	K954909	000
03596010222138	K954909	000
03596010222121	K954909	000
03596010222114	K954909	000
03596010222107	K954909	000
03596010222091	K954909	000
03596010221841	K954909	000
03596010221834	K954909	000
03596010221827	K954909	000
03596010228635	K954909	000
03596010228529	K954909	000
03596010228499	K954909	000
03596010222480	K954909	000
03596010222459	K954909	000
03596010222411	K954909	000
03596010222015	K954909	000
03596010222008	K954909	000
03596010221773	K954909	000
03596010221674	K954909	000
03596010221667	K954909	000
03596010228703	K954909	000
03596010415073	K954909	000
03596010221780	K954909	000
03596010221766	K954909	000
03596010221759	K954909	000
03596010221742	K954909	000
03596010221735	K954909	000
03596010221698	K954909	000
03596010221681	K954909	000
03596010221643	K954909	000
03596010449153	K954909	000
03596010419408	K954909	000
03596010419354	K954909	000
03596010221650	K954909	000
03596010449276	K954909	000
03596010416674	K954909	000
03596010416667	K954909	000
03596010415066	K954909	000
03596010415059	K954909	000
03596010228833	K954909	000
03596010228826	K954909	000
03596010228796	K954909	000
03596010228789	K954909	000
03596010228758	K954909	000
03596010228741	K954909	000
03596010228710	K954909	000
03596010416681	K954909	000
03596010419361	K954909	000
03596010449245	K954909	000
03596010449221	K954909	000
03596010449207	K954909	000
03596010449184	K954909	000
03596010449160	K954909	000
03596010449122	K954909	000
03596010449108	K954909	000
03596010435750	K954909	000
03596010419392	K954909	000
03596010419385	K954909	000
03596010419378	K954909	000
03596010228673	K954909	000
03596010228666	K954909	000
03596010228628	K954909	000
03596010222466	K954909	000
03596010222404	K954909	000
03596010222398	K954909	000
03596010222381	K954909	000
03596010222374	K954909	000
03596010222367	K954909	000
03596010222329	K954909	000
03596010222312	K954909	000
03596010222305	K954909	000
03596010222299	K954909	000
03596010222282	K954909	000
03596010222473	K954909	000
03596010222497	K954909	000
03596010228574	K954909	000
03596010228567	K954909	000
03596010228536	K954909	000
03596010228482	K954909	000
03596010228451	K954909	000
03596010228444	K954909	000
03596010228413	K954909	000
03596010228406	K954909	000
03596010228376	K954909	000
03596010228369	K954909	000
03596010222503	K954909	000
03596010222275	K954909	000