POLARCUP DUAL MOBILITY SYSTEM

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

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Polarcup Dual Mobility System.

Pre-market Notification Details

• Device ID: K122244
• 510k Number: K122244
• Device Name: POLARCUP DUAL MOBILITY SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: John Connor
• Correspondent: John Connor; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: KWY
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-07-27
• Decision Date: 2012-08-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07611996118391	K122244	000
07611996118285	K122244	000
07611996118292	K122244	000
07611996118308	K122244	000
07611996118315	K122244	000
07611996118322	K122244	000
07611996118339	K122244	000
07611996118346	K122244	000
07611996118353	K122244	000
07611996118360	K122244	000
07611996118377	K122244	000
07611996118384	K122244	000
07611996118278	K122244	000