INSitu Total Hip System

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

Theken Companies, LLC

The following data is part of a premarket notification filed by Theken Companies, Llc with the FDA for Insitu Total Hip System.

Pre-market Notification Details

• Device ID: K161184
• 510k Number: K161184
• Device Name: INSitu Total Hip System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: Theken Companies, LLC 1800 Triplett Blvd. Akron, OH 44306
• Contact: Dale Davison
• Correspondent: Hollace Saas Rhodes; Musculosketal Clinical Regulatory Advisors, LLC (MCRA) 1331 H Street NW, 12th Floor Washington, DC 20005
• Product Code: LPH
• Subsequent Product Code: LZO
• Subsequent Product Code: OQG
• Subsequent Product Code: OQI
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-27
• Decision Date: 2016-10-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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