Hintermann Series H3 Total Ankle Replacement System

FDA Premarket Approval P160036 S003

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 second post-approval study (pas002, hintermann series h3 tar performance study) is designed to evaluate the trend in performance between each implant size and assess the outcomes of the primary surgeon of the study (accounting for approximately 80% of the registry) compared to other surgeons that are less familiar with the device. You agree to use a prospective, multicenter, single arm study design, and hypothesis testing to evaluate the performance of the different implant sizes of the hintermann series h3 tar system compared to the hintermann series h3 tar system performance in the pse cohort. Multiple investigators unfamiliar with the device will be recruited so that one surgeon does not conduct the majority of the cases and to evaluate the impact of experience on overall outcomes. You have agreed to enroll 232 new study subjects at up to 10 us sites and to follow these subjects for 5 years. Study subjects will undergo clinical and radiographic evaluation postoperatively at 6 weeks, 6 months, and yearly afterwards. You have agreed to take reasonable measures to avoid loss to follow-up. A follow-up rate of 85% is expected at each timepoint. You have agreed to collect and analyze information about safety, including any reoperation, revisions or removals of the hintermann ankle device, and effectiveness endpoints, including the american orthopaedic foot and ankle society at 2 years or more, the survivorship (absence of removal/revisions to include polyethylene revision) within 5 years, the percentage of subjects with a serious device-related adverse event other than a revision or removal within 2 years, as well as vas score, patient satisfaction, and sf-36 for general well-being. You will also collect information about all adverse events reported for these patients, including details of the nature, onset, duration, severity, relationship to the device, and relationship to the operative procedure and outcome. Additionally, you have agreed to provide radiographic assessments of all enrolled subjects as well as a detailed explant analysis of any explanted devices during the pas.

DeviceHintermann Series H3 Total Ankle Replacement System
Generic NameProsthesis, Ankle, Uncemented, Non-constrained
ApplicantDT MedTech LLC
Date Received2021-09-10
Decision Date2021-10-15
PMAP160036
SupplementS003
Product CodeNTG 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination Product No
Applicant Address DT MedTech LLC 110 West Road suite 227 towson, MD 21204

Supplemental Filings

Supplement NumberDateSupplement Type
P160036Original 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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