MUTARS Proximal Femur Replacement System

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

Implantcast GmbH

The following data is part of a premarket notification filed by Implantcast Gmbh with the FDA for Mutars Proximal Femur Replacement System.

Pre-market Notification Details

• Device ID: K181778
• 510k Number: K181778
• Device Name: MUTARS Proximal Femur Replacement System
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• Applicant: implantcast GmbH Lueneburger Schanze 26 Buxtehude, DE 21614
• Contact: Juliane Hoppner
• Correspondent: Dave Mcgurl; Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001
• Product Code: MEH
• Subsequent Product Code: KWY
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-03
• Decision Date: 2019-03-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048844428549	K181778	000
04048844050788	K181778	000
04048844050795	K181778	000
04048844050801	K181778	000
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04048844146382	K181778	000
04048844065515	K181778	000
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04048844124939	K181778	000