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Hintermann Series H3 Total Ankle Replacement System

FDA PMA

Class III (US FDA PMA)

PMA P160036

by Dt Medtech, LLC

Identity

Trade Name
Hintermann Series H3 Total Ankle Replacement System FDA PMA
Generic Name
Prosthesis, ankle, uncemented, non-constrained FDA PMA

Identifiers

PMA Number
P160036 FDA PMA
FDA Product Code
NTG FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Orthopedic FDA PMA
FDA Decision
APPR Approved FDA PMA

The Hintermann Series H3 Total Ankle Replacement System is a Prosthesis, Ankle, Uncemented, Non-Constrained, designed as a three-component, mobile-bearing implant. It is intended for non-cemented placement to replace a painful arthritic ankle joint caused by primary osteoarthritis, post-traumatic osteoarthritis, or inflammatory arthritis (e.g., rheumatoid arthritis, hemochromatosis).

This system is supplied as a prescription-only device and is approved for use in the United States under an FDA PMA (P160036). The implant is intended for surgical use in orthopedic settings and is not intended for MRI compatibility. No specific sterility or single-use/reusable designation is stated in the data. The system includes multiple component sizes, as referenced by the associated UDI numbers, and must be handled and stored according to manufacturer instructions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: H3 ANKLE - DT MedTech, Hintermann Series H3® | DT MedTech, Vilex, Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected ..., Hintermann Series H3 Total Ankle Replacement System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Dt Medtech, LLC

Sources (1)

  • FDA PMA P160036 24 fields · synced Sep 18, 2026