ITotal® Hip Replacement System

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

ConforMIS, Inc.

The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Itotal® Hip Replacement System.

Pre-market Notification Details

• Device ID: K162719
• 510k Number: K162719
• Device Name: ITotal® Hip Replacement System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: ConforMIS, Inc. 28 Crosby Drive Bedford, MA 01730
• Contact: Amita Shah
• Correspondent: Emmanuel Nyakako; ConforMIS, Inc. 600 Technology Park Drive Billerica, MA 01821
• Product Code: LPH
• Subsequent Product Code: LZO
• Subsequent Product Code: MEH
• Subsequent Product Code: OQG
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-29
• Decision Date: 2017-06-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M572HDL060C10F011	K162719	000
M572HAR000S256011	K162719	000
M572HAR000S255011	K162719	000
M572HAR000S254011	K162719	000
M572HAR000S253011	K162719	000
M572HAR000S252011	K162719	000
M572HAR000S251011	K162719	000
M572HAR000S250011	K162719	000
M572HAR000S249011	K162719	000
M572HAR000S248011	K162719	000
M572HAR000S247011	K162719	000
M572HAR000S246011	K162719	000
M572HAR000S245011	K162719	000
M572HAR000S165011	K162719	000
M572HAR000S164011	K162719	000
M572HAR000S257011	K162719	000
M572HAR000S258011	K162719	000
M572HDL060B14S011	K162719	000
M572HDL060B12S011	K162719	000
M572HDL060B12L011	K162719	000
M572HDL060B12F011	K162719	000
M572HDL060B00S011	K162719	000
M572HDL060B00L011	K162719	000
M572HDL060B00F011	K162719	000
M572HAR000S265011	K162719	000
M572HAR000S264011	K162719	000
M572HAR000S263011	K162719	000
M572HAR000S262011	K162719	000
M572HAR000S261011	K162719	000
M572HAR000S260011	K162719	000
M572HAR000S259011	K162719	000
M572HAR000S163011	K162719	000
M572HAR000S162011	K162719	000
M572HAR000S161011	K162719	000
M572HAA0300640011	K162719	000
M572HAA0300635011	K162719	000
M572HAA0300630011	K162719	000
M572HAA0300625011	K162719	000
M572HAA0300620011	K162719	000
M572HAA0300615011	K162719	000
M572HCC0320000011	K162719	000
M572HAA050D001011	K162719	000
M572HDL060D20F011	K162719	000
M572HDL060C24S011	K162719	000
M572HDL060C22S011	K162719	000
M572HDL060C22L011	K162719	000
M572HDL060C22F011	K162719	000
M572HDL060C10S011	K162719	000
M572HAA0300645011	K162719	000
M572HAA0300650011	K162719	000
M572HAR000S160011	K162719	000
M572HAR000S159011	K162719	000
M572HAR000S157011	K162719	000
M572HAR000S156011	K162719	000
M572HAR000S155011	K162719	000
M572HAR000S154011	K162719	000
M572HAR000S153011	K162719	000
M572HAR000S152011	K162719	000
M572HAR000S151011	K162719	000
M572HAR000S150011	K162719	000
M572HAR000S149011	K162719	000
M572HAR000S147011	K162719	000
M572HAR000S146011	K162719	000
M572HAR000S145011	K162719	000
M572HBS0330000011	K162719	000
M572HDL060C10L011	K162719	000
M572HAH01036XL011	K162719	000
M572HAH04036SH011	K162719	000
M572HAH04036MD011	K162719	000
M572HAH04036LG011	K162719	000
M572HAH04032XL011	K162719	000
M572HAH04032SH011	K162719	000
M572HAH04032MD011	K162719	000
M572HAH04032LG011	K162719	000
M572HAH04028SH011	K162719	000
M572HAH04028MD011	K162719	000
M572HAH04028LG011	K162719	000
M572HDL060F34S011	K162719	000
M572HDL060F32S011	K162719	000
M572HDL060F32L011	K162719	000
M572HDL060F32F011	K162719	000
M572HAH04036XL011	K162719	000
M572HAH04040LG011	K162719	000
M572HAH01036SH011	K162719	000
M572HAH01036MD011	K162719	000
M572HAH01036LG011	K162719	000
M572HAH01032XL011	K162719	000
M572HAH01032SH011	K162719	000
M572HAH01032MD011	K162719	000
M572HAH01032LG011	K162719	000
M572HAH01028XL011	K162719	000
M572HAH01028SH011	K162719	000
M572HAH01028MD011	K162719	000
M572HAH01028LG011	K162719	000
M572HAH04040XL011	K162719	000
M572HAH04040SH011	K162719	000
M572HAH04040MD011	K162719	000
M572HDL060F30S011	K162719	000
M572HDL060F30L011	K162719	000
M572HDL060F30F011	K162719	000
M572HDL060E22L011	K162719	000
M572HDL060E22F011	K162719	000
M572HDL060E20S011	K162719	000
M572HDL060E20L011	K162719	000
M572HDL060E20F011	K162719	000
M572HDL060D34S011	K162719	000
M572HDL060D32S011	K162719	000
M572HDL060D32L011	K162719	000
M572HDL060D32F011	K162719	000
M572HDL060D24S011	K162719	000
M572HDL060D22S011	K162719	000
M572HDL060D22L011	K162719	000
M572HDL060D22F011	K162719	000
M572HDL060D20S011	K162719	000
M572HDL060E22S011	K162719	000
M572HDL060E24S011	K162719	000
M572HDL060F24S011	K162719	000
M572HDL060F22S011	K162719	000
M572HDL060F22L011	K162719	000
M572HDL060F22F011	K162719	000
M572HDL060F20S011	K162719	000
M572HDL060F20L011	K162719	000
M572HDL060F20F011	K162719	000
M572HDL060E34S011	K162719	000
M572HDL060E32S011	K162719	000
M572HDL060E32L011	K162719	000
M572HDL060E32F011	K162719	000
M572HDL060E30S011	K162719	000
M572HDL060E30L011	K162719	000
M572HDL060E30F011	K162719	000
M572HDL060D20L011	K162719	000