Klassic HD® Hip System

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

Total Joint Othopedics, Inc.

The following data is part of a premarket notification filed by Total Joint Othopedics, Inc. with the FDA for Klassic Hd® Hip System.

Pre-market Notification Details

• Device ID: K171962
• 510k Number: K171962
• Device Name: Klassic HD® Hip System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: Total Joint Othopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106
• Contact: Chris Weaber
• Correspondent: Chris Weaber; Total Joint Othopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106
• Product Code: LPH
• Subsequent Product Code: LZO
• Subsequent Product Code: MBL
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-06-30
• Decision Date: 2017-07-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00814703013607	K171962	000
00814703013591	K171962	000
00814703013584	K171962	000
00814703013577	K171962	000
00814703013560	K171962	000
00814703013553	K171962	000