Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-constrained

FDA Premarket Approval P160036 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

The post-approval study protocols for the two post-approval studies that dt medtech agreed to conduct as part of the conditions of approval for the hintermann series h3 total ankle replacement system pma (p160036), approved on may 4, 2019. The first post-approval study (pas 001) is designed to evaluate the long-term safety and effectiveness of the hintermann series h3 tar system among patients included in the primary safety and effectiveness (pse) cohort. The second post-approval study (pas 002) is designed to evaluate the trend in performance between each implant size and assess the outcomes of the primary surgeon of the pma study (he accounted for 80% of the pse registry cohort) compared to other surgeons that are less familiar with the device.

DeviceHintermann Series H3 Total Ankle Replacement System
Classification NameProsthesis, Ankle, Uncemented, Non-constrained
Generic NameProsthesis, Ankle, Uncemented, Non-constrained
ApplicantDT MedTech LLC
Date Received2019-07-01
Decision Date2019-11-29
PMAP160036
SupplementS001
Product CodeNTG
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address DT MedTech LLC 110 West Road suite 227 towson, MA 21204

Supplemental Filings

Supplement NumberDateSupplement Type
P160036Original Filing
S001 2019-07-01 Normal 180 Day Track No User Fee

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