K Number
K171004
Device Name
Hintermann Series H2 Total Ankle System
Manufacturer
Date Cleared
2017-11-07

(217 days)

Product Code
Regulation Number
888.3110
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The document describes a mechanical implant for ankle replacement and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are focused on mechanical and material properties.

Yes
The device is a total ankle replacement system designed to treat ankle arthritis by replacing the ankle joint, which directly addresses a medical condition and aims to restore function and reduce pain.

No

This device is a total ankle replacement system, which is a prosthesis used to treat ankle arthritis by replacing the damaged joint, not a device that diagnoses a condition.

No

The device description explicitly states that the system includes metal and polyethylene components, indicating it is a physical implant, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a surgical implant designed to replace the ankle joint to treat arthritis. This is a therapeutic device, not a diagnostic one.
  • Device Description: The description details the physical components of the implant (metal tibial component, polyethylene inlay, metal talar component). This aligns with a surgical implant, not a device used to perform tests on biological samples.
  • Performance Studies: The non-clinical testing summary focuses on the mechanical and material properties of the implant (coating characterization, range of motion, fatigue, wear, etc.). These are relevant tests for a surgical implant, not for evaluating the performance of a diagnostic test.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.

In summary, the Hintermann Series H2 Total Ankle Replacement system is a surgical implant intended for therapeutic use, not a device used for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

HSN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ankle joint

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Integra (Cadence) Total Ankle Replacement System, Integra LifeSciences, Inc., K151459, INBONE I and II Total Ankle Replacement, Wright Medical Technologies, K051023, K100886, K123059, K133585, Salto Talaris Total Ankle Prosthesis, Integra LifeSciences, Inc., K060544, K090076, K130533, K153452, Exactech Vantage Total Ankle System, Exactech Inc., K152217

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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.

1

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

2

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 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.

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

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3

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

| Sponsor: | DT MedTech, LLC.
110 West Road
Suite 227
Towson, MD 21204 |
|--------------------|-------------------------------------------------------------------------------------------------------------|
| Contact: | Shawn T. Huxel
Executive Vice President
Phone: 410-427-0003
Fax: 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 cemented
prosthesis. |
| Product Code: | HSN |
| Predicate Devices: | Integra (Cadence) Total Ankle Replacement System, Integra
LifeSciences, Inc., K151459 |
| | INBONE I and II Total Ankle Replacement, Wright Medical
Technologies, 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:

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.

4

Indications for Use:

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/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.

| | Hintermann
Series H2 | Vantage | Cadence | Inbone II | Salto Talaris |
|-------------------------|----------------------------|----------------------------|----------------------------|------------------------------------------|------------------------------------------|
| Manufacturer | DT MedTech | Exactech | Integra Life
Sciences | Wright Medical
Technology, Inc | Tornier |
| Submission
number | K171004 | K152217 | K151459 | K051023
K100886
K123059
K133585 | K060544
K090076
K130533
K153452 |
| Indications for
use | Total ankle
replacement | Total ankle
replacement | Total ankle
replacement | Total ankle
replacement | Total ankle
replacement |
| Method of
fixation | Cemented | Cemented | Cemented | Cemented | Cemented |
| Sterilization
method | Gamma | Gamma | Gamma | Gamma | Gamma |

5

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

| | Hintermann
Series H2 | Vantage | Cadence | Inbone II | Salto Talaris |
|---------------------|--------------------------------------------------------------------------------|----------------------------|-----------------------------------------------|----------------------------------------------------|----------------------------------|
| Materials | | | | | |
| Tibial
component | 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 | Titanium
plasma spray | Porous titanium
coating | Porous titanium
coating | Titanium
plasma spray | Titanium
plasma spray |
| Sizes | | | | | |
| Tibial
component | 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

6

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.