Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-constrained

FDA Premarket Approval P160036

Pre-market Approval Supplement Details

The hintermann series h3 total ankle replacement system is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease (e. G. Rheumatoid arthritis, hemochromatosis, etc. ). The device system is for prescription use.

• Device: Hintermann Series H3 Total Ankle Replacement System
• Classification Name: Prosthesis, Ankle, Uncemented, Non-constrained
• Generic Name: Prosthesis, Ankle, Uncemented, Non-constrained
• Applicant: DT MedTech LLC
• Date Received: 2016-08-24
• Decision Date: 2019-06-04
• PMA: P160036
• Supplement: S
• Product Code: NTG
• Advisory Committee: Orthopedic
• Expedited Review: No
• Combination Product: No
• Applicant Address: DT MedTech LLC 110 West Road suite 227 towson, MA 21204

Supplemental Filings

Supplement Number	Date	Supplement Type
P160036		Original Filing
S003	2021-09-10	Normal 180 Day Track No User Fee
S002	2021-02-26	30-day Notice
S001	2019-07-01	Normal 180 Day Track No User Fee

NIH GUDID Devices

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