Cleared Traditional

K171004 - Hintermann Series H2 Total Ankle System

K171004 is an FDA 510(k) clearance for Hintermann Series H2 Total Ankle System, manufactured by Dt Medtech, LLC. The device is a Class 2 Orthopedic device with product code HSN cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K171004 · Dt Medtech, LLC · Orthopedic device
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Nov 2017
Decision
217d
Days
Class 2
Risk

K171004 is an FDA 510(k) clearance for the Hintermann Series H2 Total Ankle System. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Dt Medtech, LLC (Towson, US). The FDA issued a Cleared decision on November 7, 2017 after a review of 217 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3110 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Dt Medtech, LLC devices

FDA 510(k) Submission Details - K171004

510(k) Number K171004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2017
Decision Date November 07, 2017
Days to Decision 217 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 122d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSN Device Classification - Class 2, Special Controls

Product Code HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3110
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

All 62
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K171004.
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INVISION Total Ankle Revision System
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PROPHECY INVISION Preoperative Navigation Alignment System
K162795 · Wrightmedicaltechnologyinc · Feb 2017