U.S. Food & Drug Administration 10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 1 . 9 7 Silver Spring, MD 20993 www.fda.gov

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 - Marcos Velez-Duran K171004

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,

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

Radiological Health

Enclosure

Katherine D. Kavlock -S

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K171004

510(k) Summary Hintermann Series H2 Total Ankle System 

K171004 

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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 

 DatePrepared:  November 1, 2017  TradeName:  Hintermann Series H2™ Total Ankle System  CommonName:   Total ankle prosthesis  Classification:  888.3110 Ankle joint metal/polymer semi‐constrained cemented 

prosthesis.  ProductCode:   HSN  PredicateDevices:  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  

 DescriptionofDevice:

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  semi‐

constrained device used for the indications as follows.  

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

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IndicationsforUse:

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. 

ComparisonofTechnologicalCharacteristicswiththePredicateDevice:

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 

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

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  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  SubstantialEquivalence:

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  

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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. 

  

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