PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT

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

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Profix Flex Cruciate Retaining Articular Insert.

Pre-market Notification Details

• Device ID: K051229
• 510k Number: K051229
• Device Name: PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Jason Sells
• Correspondent: Jason Sells; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-05-13
• Decision Date: 2005-07-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03596010542977	K051229	000
03596010538826	K051229	000
03596010538833	K051229	000
03596010538840	K051229	000
03596010538857	K051229	000
03596010538864	K051229	000
03596010538871	K051229	000
03596010538888	K051229	000
03596010538895	K051229	000
03596010542908	K051229	000
03596010542915	K051229	000
03596010538819	K051229	000
03596010538802	K051229	000
03596010543059	K051229	000
03596010543103	K051229	000
03596010001511	K051229	000
03596010538734	K051229	000
03596010538741	K051229	000
03596010538758	K051229	000
03596010538765	K051229	000
03596010538772	K051229	000
03596010538789	K051229	000
03596010538796	K051229	000
03596010542922	K051229	000
03596010542939	K051229	000
03596010543080	K051229	000
03596010543097	K051229	000
03596010543110	K051229	000
03596010547156	K051229	000
03596010547163	K051229	000
03596010547170	K051229	000
03596010547187	K051229	000
03596010547194	K051229	000
03596010547200	K051229	000
03596010547217	K051229	000
03596010543073	K051229	000
03596010543066	K051229	000
03596010542946	K051229	000
03596010542953	K051229	000
03596010542960	K051229	000
03596010542984	K051229	000
03596010542991	K051229	000
03596010543004	K051229	000
03596010543011	K051229	000
03596010543028	K051229	000
03596010543035	K051229	000
03596010543042	K051229	000
03596010547224	K051229	000