The Hintermann Series H2 Total Ankle Replacement (Hintermann Series H2) system is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, replacing flexion and extension movement in the ankle joint, and allowing for movement at the replaced joint.

The Hintermann Series H2 is indicated as a total ankle replacement in primary or revision surgery of ankle joints damaged by:

· Systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis)

· Primary arthritis (e.g., degenerative disease)

· Secondary arthritis (e.g., post-traumatic, avascular necrosis, provided enough of the talus is preserved to support the implant)

The Hintermann Series H2 is also indicated for patients with a failed previous ankle surgery and revision surgeries following failed total ankle replacement or non-union of the ankle arthrodesis, provided sufficient bone stock is present.

Note: In the United States, this device is intended for cemented use only.

Device Description

The Hintermann Series H2 Total Ankle System includes a metal tibial component, polyethylene inlay, and metal talar component. The tibial and talar components are coated with plasma spray titanium on the bone contacting surfaces. The system is a semiconstrained device used for the indications as follows.

AI/ML Overview

This document is a 510(k) summary for the Hintermann Series H2 Total Ankle System, asserting its substantial equivalence to previously marketed predicate devices. It focuses on the device's design, materials, and nonclinical testing to demonstrate safety and effectiveness.

Here's an analysis of the provided text in relation to your request about acceptance criteria and supportive studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a clear table of specific, quantitative acceptance criteria with corresponding reported device performance values. Instead, it lists types of non-clinical tests performed and states that the comparisons confirmed substantial equivalence to predicate devices. It implies that meeting the standards of ASTM F2665 and FDA guidance constitutes the acceptance criteria, but doesn't quantify results against specific thresholds.

Here's a conceptual representation, though explicit numeric values are missing from the text:

Acceptance Criterion (Implied Standard)	Reported Device Performance
Coating characterization per FDA Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants (Feb 2, 2000)	Testing conducted; confirmed substantial equivalence.
Range of motion analysis per ASTM F2665	Testing conducted; confirmed substantial equivalence.
Fatigue testing per ASTM F2665	Testing conducted; confirmed substantial equivalence.
Contact area/contact stress analysis per ASTM F2665	Testing conducted; confirmed substantial equivalence.
Constraint testing per ASTM F2665	Testing conducted; confirmed substantial equivalence.
Tibial Component locking mechanism testing	Testing conducted; confirmed substantial equivalence.
Wear testing per ASTM F2665	Testing conducted; confirmed substantial equivalence.
Endotoxin testing per FDA guidance	Testing conducted; confirmed substantial equivalence.
Overall safety, effectiveness, and performance compared to predicate devices, regarding intended use, product technical characteristics, and performance characteristics as defined by ASTM F2665.	"Confirmed that the Hintermann Series H2 Total Ankle System is substantially equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

The document details non-clinical testing, which refers to laboratory or bench testing, not human-subject clinical trials. Therefore, concepts like "test set" in the context of patient data, data provenance (e.g., country of origin), or retrospective/prospective studies are not applicable to the information provided. The "sample size" for the non-clinical tests would refer to the number of physical device units or components tested for each specific test (e.g., 5 units for fatigue testing), but this information is not specified in the provided text.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since this is a non-clinical device clearance based on substantial equivalence, there is no "test set" of patient data and therefore no experts used to establish ground truth in the way you might find in an AI/diagnostic device submission. The "ground truth" here is adherence to engineering standards and material specifications, verified through laboratory testing.

4. Adjudication Method for the Test Set

As there is no patient data test set or expert review, an adjudication method is not applicable to this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, often with and without AI assistance. The Hintermann Series H2 Total Ankle System is an implantable medical device, and its clearance is based on non-clinical engineering and material performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the Hintermann Series H2 Total Ankle System is a physical implant, not an algorithm or AI-powered device.

7. The Type of Ground Truth Used

For this non-clinical submission, the "ground truth" is defined by:

Established engineering standards: Specifically, ASTM F2665 ("Standard Specification for Total Ankle Replacement Prosthesis").
FDA guidance documents: Such as the "FDA Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements dated February 2, 2000" and general FDA guidance for endotoxin testing.
Material specifications: For titanium alloy, UHMWPE, and CoCr alloy.

The "ground truth" is that the device, when subjected to these tests, performs within the acceptable parameters defined by these standards and demonstrates properties comparable to legally marketed predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. The device is an implant and does not involve machine learning or AI, and therefore has no "training set."

9. How the Ground Truth for the Training Set was Established

This question is not applicable as no training set exists for this device.

Summary

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November 7, 2017

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

DT MedTech LLC % Marcos Velez-Duran President M Squared Associates, Inc 575 8th Avenue, Suite 1212 New York, New York 10018

Re: K171004

Trade/Device Name: Hintermann Series H2 Total Ankle System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN Dated: October 11, 2017 Received: October 12, 2017

Dear Marcos Velez-Duran:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K171004

Device Name Hintermann Series H2 Total Ankle System

Indications for Use (Describe)

The Hintermann Series H2 is indicated as a total ankle replacement in primary or revision surgery of ankle joints damaged by:

· Systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis)

· Primary arthritis (e.g., degenerative disease)

· Secondary arthritis (e.g., post-traumatic, avascular necrosis, provided enough of the talus is preserved to support the implant)

Note: In the United States, this device is intended for cemented use only.

Type of Use ( Select one or both, as applicable )
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Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Hintermann Series H2 Total Ankle System K171004

Sponsor:	DT MedTech, LLC.110 West RoadSuite 227Towson, MD 21204
Contact:	Shawn T. HuxelExecutive Vice PresidentPhone: 410-427-0003Fax: 410-494-0515
Date Prepared:	November 1, 2017
Trade Name:	Hintermann Series H2™ Total Ankle System
Common Name:	Total ankle prosthesis
Classification:	888.3110 Ankle joint metal/polymer semi-constrained cementedprosthesis.
Product Code:	HSN
Predicate Devices:	Integra (Cadence) Total Ankle Replacement System, IntegraLifeSciences, Inc., K151459
	INBONE I and II Total Ankle Replacement, Wright MedicalTechnologies, K051023, K100886, K123059, K133585
	Salto Talaris Total Ankle Prosthesis, Integra LifeSciences, Inc.,K060544, K090076, K130533, K153452
	Exactech Vantage Total Ankle System, Exactech Inc., K152217

Description of Device:

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Indications for Use:

The Hintermann Series H2 is indicated as a total ankle replacement in primary or revision surgery of ankle joints damaged by:

. Systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis)
Primary arthritis (e.g., degenerative disease)
Secondary arthritis (e.g., post-traumatic, avascular necrosis, provided enough of the talus is preserved to support the implant)

The Hintermann Series H2 is also indicated for patients with a failed previous ankle surgery and revision surgeries following failed total ankle replacement or non-union/mal-union of the ankle arthrodesis, provided sufficient bone stock is present. Note: In the United States, this device is intended for cemented use only.

Comparison of Technological Characteristics with the Predicate Device:

The technological characteristics for the Hintermann Series H2 Total Ankle System are the similar to, or the same as, the characteristics of the predicate devices as outlined in the table that follows.

	HintermannSeries H2	Vantage	Cadence	Inbone II	Salto Talaris
Manufacturer	DT MedTech	Exactech	Integra LifeSciences	Wright MedicalTechnology, Inc	Tornier
Submissionnumber	K171004	K152217	K151459	K051023 K100886 K123059 K133585	K060544 K090076 K130533 K153452
Indications foruse	Total anklereplacement	Total anklereplacement	Total anklereplacement	Total anklereplacement	Total anklereplacement
Method offixation	Cemented	Cemented	Cemented	Cemented	Cemented
Sterilizationmethod	Gamma	Gamma	Gamma	Gamma	Gamma

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Hintermann Series H2 Total Ankle System K171004 510(k) Summary

	HintermannSeries H2	Vantage	Cadence	Inbone II	Salto Talaris
Materials
Tibialcomponent	Titanium Alloy	Titanium Alloy	Titanium Alloy	Titanium Alloy	CoCr alloy
Poly insert	UHMWPE	UHMWPE	UHMWPE	UHMWPE	UHMWPE
Talar component	CoCr alloy	CoCr alloy	CoCr alloy	CoCr alloy	CoCr alloy
Coating	Titaniumplasma spray	Porous titaniumcoating	Porous titaniumcoating	Titaniumplasma spray	Titaniumplasma spray
Sizes
Tibialcomponent	5 sizes (2, 3, 4,5, 6)	Not reported	9 sizes (1, 1X, 2,2X, 3, 3X, 4, 4X,5)	9 sizes (size 2,2L, 3, 3L, 4, 4L,5, 5L, 6)	4 sizes (0, 1, 2,3)
Poly insert	6 sizes (1, 2, 3,4, 5, 6)	Not reported	5 sizes (1, 2, 3,4, 5)	5 sizes (1+, 2, 3,4, 5)	5 sizes (size 00,0, 1, 2, 3)
Talar component	Std: 6 sizes (1,2, 3, 4, 5, 6)Flat cut: 5 sizes(1, 2, 3, 4, 5)	Not reported	5 sizes (1, 2, 3,4, 5)	5 sizes (1, 2, 3,4, 5)	4 sizes (0, 1, 2,3)

Nonclinical Testing Summary:

Following is a summary of the non-clinical testing that was conducted:

. Coating characterization per FDA Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements dated February 2, 2000
. Range of motion analysis per ASTM F2665
Fatigue testing per ASTM F2665
Contact area/contact stress analysis per ASTM F2665
Constraint testing per ASTM F2665
Tibial Component locking mechanism testing
Wear testing per ASTM F2665
Endotoxin testing per FDA guidance

Substantial Equivalence:

The design features of the Hintermann Series H2 Total Ankle System are substantially equivalent to the design features of other predicate devices previously cleared for market. The methods used to establish equivalence are based on the comparison of the intended use, product technical characteristics and performance characteristics as defined by ASTM F2665 Standard Specification for Total Ankle Replacement Prosthesis. All comparisons

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Hintermann Series H2 Total Ankle System K171004 510(k) Summary

confirmed that the Hintermann Series H2 Total Ankle System is substantially equivalent to the predicate devices. The safety, effectiveness, and performance of the Hintermann Series H2 Total Ankle System are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification. Therefore, it is concluded that the Hintermann Series H2 Total Ankle System is substantially equivalent to the noted predicate devices.

Conclusions:

While the Hintermann Series H2 Total Ankle System is not identical to the predicate devices, any differences that may exist do not significantly affect device safety and effectiveness. In addition, the differences do not add new or increased risks and complications. Therefore, it is concluded that the Hintermann Series H2 Total Ankle System is substantially equivalent to the predicate devices as outlined previously.

Regulation Number and Section

§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.