Salto XT, Salto Talaris

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing the department's mission to protect the health of all Americans and provide essential human services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 11, 2016 Tornier Sas Séverine BONNETON Regulatory Affairs Manager. Special Projects 161 rue Lavoisier 38330 Montbonnot Saint Martin FRANCE Re: K153452 Trade/Device Name: Salto XT, Salto Talaris Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSN Dated: July 11, 2016 Received: July 12, 2016 Dear Ms. BONNETON: 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # VincentJ. Devlin -S for - Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. # DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K153452 Device Name Salto Talaris Indications for Use (Describe) The Salto Talaris ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Components are intended for cemented use only. Type of Use (Select one or both, as applicable) [X] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. # DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K153452 Device Name Salto XT Indications for Use (Describe) The Salto XT ankle prosthesis is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Components are intended for cemented use only. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the word "TORNIER" in large, bold, blue font. Below that, in a smaller, bold, blue font, are the words "Implants Chirurgicaux". The text appears to be a logo or heading for a company or product related to surgical implants. # Summary of Safety and Effectiveness information Traditional 510(k) Premarket - Salto XT, Salto Talaris Regulatory authority: 21 CFR 807.92 Date prepared: 25 November 2015 | 1) Device name | | |----------------------|-------------------------------------------------------------------------| | Trade name: | Salto XT | | Common name: | Total-Ankle Prosthesis | | Classification name: | 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis | | Trade name: | Salto Talaris | | Common name: | Total-Ankle Prosthesis | | Classification name: | 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis | 2) Submitter : TORNIER SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin- France Registration Number: 3000931034 # 3) Company contact : Tornier Mrs Séverine BONNETON Regulatory Affairs Manager, Special Projects 161, rue Lavoisier 38334 Montbonnot Saint-Martin - FRANCE Tel: 00 33 4 76 61 35 51 Fax: 00 33 4 76 61 35 59 E-mail: severine.bonneton(a)tornier.com # 4) Classification | Device class: | Class II | |-----------------------|------------| | Classification panel: | Orthopedic | | Product code: | HSN | - 5) Equivalent / Predicate device : Primary predicate: Salto Talaris, TORNIER, K060544, K090076, K130533. Image /page/4/Picture/13 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is formed by two overlapping shapes, creating a three-dimensional effect. The color of the logo is a light shade of blue or purple. The logo appears to be simple and modern. TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE {5}------------------------------------------------ Reference predicates: Inbone II Total Ankle System, Wright Medical Technology, Inc, K100886, K103374, K133585. Infinity Total Ankle System, Wright Medical Technology, Inc, K123954, K140749 Agility Total Ankle Prosthesis. Depuy. Inc: K020541, K053569, K122395 #### 6) Device description : The cleared Salto Talaris and the new Salto XT are intended for total ankle replacement. Both are a semiconstrained anatomical design, which reproduces the kinematics of the ankle joint. And both consist of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar component. The submission seeks clearance for: - the addition of new components to the Salto XT (tibial and talar components). - the addition of a new size and new thicknesses to the cleared range of Salto Talaris tibial inserts. The tibial inserts are compatible with both Salto Talaris (K060544, K090076, K130533) and the new Salto XT. The new device Salto XT has been designed to be compatible with the cleared and the new Salto Talaris tibial inserts. All Salto XT components are compatible with cleared Salto Talaris components. ## 7) Materials : The Salto XT tibial base is manufactured from titanium alloy and the Salto XT talar component is manufactured from chromium cobalt alloy. The Salto XT tibial and talar components are coated with titanium plasma spray. The Salto Talaris tibial inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). #### 8) Indications : #### Salto XT: The Salto XT ankle prosthesis is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Components are intended for cemented use only. #### Salto Talaris: The Salto Talaris ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Components are intended for cemented use only. Image /page/5/Picture/18 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is rendered in a light blue color and appears to be composed of two overlapping 'T' shapes, one slightly smaller and nested within the larger one. The hexagon provides a clean, geometric border around the central 'T' design, giving the logo a modern and professional look. TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTN - FRANCE {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "TORNIER" in large, bold, blue font. Below that, in a smaller, bold, blue font, are the words "Implants Chirurgicaux". The text appears to be a logo or brand name. # 9) Summary of technological characteristics | Main features or system<br>characteristics | | Salto XT | Salto Talaris | INBONE II | INFINITY | AGILITY | |--------------------------------------------|---------------------|------------------------------------------------|-------------------------------|------------------------------------------------------------|-----------------------------------------------------------|-------------------------------------------------| | Materials | Tibial<br>component | Titanium alloy | CoCr alloy | Titanium alloy | Titanium alloy | Titanium alloy | | | Tibial Insert | UHMWPE | UHMWPE | UHMWPE | UHMWPE | UHMWPE | | | Talar<br>component | CoCr alloy | CoCr alloy | CoCr alloy | Titanium alloy | CoCr alloy | | | Coating | Titanium<br>plasma spray | Titanium plasma<br>spray | Titanium plasma<br>spray | Commercially<br>pure Titanium | Commercially<br>pure Titanium | | Sizes | Tibial<br>component | 4 sizes | 4 sizes | 9 sizes<br>(right & left) | 8 sizes | 6 sizes<br>(right & left) | | | Tibial insert | 5 sizes cleared + 1 new size<br>(right & left) | | 10 sizes with<br>different<br>thicknesses for<br>each size | 8 sizes with<br>different<br>thicknesses for<br>each size | 6 sizes (insert /<br>revision /<br>revision +2) | | | Talar<br>component | 4 sizes<br>(right & left) | 4 sizes<br>(right & left) | 5 sizes<br>(right & left) | 5 sizes | 6 sizes (posterior<br>augmented /<br>revision) | | Indications for use | | Total ankle<br>replacement | Total ankle<br>replacement | Total ankle<br>replacement | Total ankle<br>replacement | Total ankle<br>replacement | | Method of fixation | | cemented | cemented | cemented | cemented | cemented | | Terminal sterilization | | Gamma | Gamma | Gamma | Gamma | Gamma | | Manufacturer | | Tornier | Tornier | Wright Medical<br>Technology, Inc | Wright Medical<br>Technology, Inc | Depuy, Inc | | K-number | | K153452 | K060544<br>K090076<br>K130533 | K100886<br>K103374<br>K123059 | K123954<br>K140749 | K020541<br>K053569<br>K122395 | The indications for use, materials, method of fixation processes for the Salto XT are identical or equivalent to the predicate devices. Image /page/6/Picture/4 description: The image shows a logo with a blue hexagon containing a stylized letter 'T'. The 'T' is formed by two overlapping shapes, creating a three-dimensional effect. The logo is simple and clean, with a focus on the geometric shapes and the color blue. TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN -FRANCE Image /page/6/Picture/10 description: The image is a solid black rectangle. The rectangle is oriented horizontally. The background is white. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "TORNIER" in large, bold, blue letters. Below the word "TORNIER" is the phrase "Implants Chirugicaux" in smaller, blue letters. The text appears to be a logo or heading for a company or product related to surgical implants. #### 10) Non-clinical testing The following non-clinical tests were performed: - Tibial fatigue The aim of the tibial fatigue test is to evaluate the fatigue strength of the Salto XT . tibial tray. - Insert locking mechanism The aim of the insert locking mechanism test is to measure the locking strength of insert and tray assembly. - Talar stability with bone: The aim of talar stability test is to check the talar connection to the bone of the Salto XT. - -Contact pressure - The aim of the contact pressurement test is to compare the contact pressure profile between the Salto XT talar component and its predicate device. - -Wear - The aim of the wear test is to check the resistance of the Salto XT and to compare it to the resistance of the predicate. The results of these tests demonstrate that the proposed new Salto Talaris tibial inserts are equivalent to the predicate devices. # 11) Substantial conclusion equivalence Based upon comparative analysis, substantial equivalence of the new Salto XT and the new Salto Talaris tibial inserts to the predicates can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision Making Process: - The Salto XT and Salto Talaris inserts are comparable to the predicate devices. ı - The Salto XT and Salto Talaris inserts have the same intended use as the cleared predicates and have same/similar indications for use. - -Major technological characteristics are equivalent between the Salto Talaris inserts and the predicate devices: - Equivalence of general features - - -Equivalent materials, - -Equivalent biomechanical features: mechanical characteristics, congruence of articular surfaces, - Equivalent means of fixation - - -Equivalent prosthetic dimensions Therefore, in light of the above information, the Salto Talaris inserts are found to be equivalent to the predicate devices. Image /page/7/Picture/20 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is rendered in a light blue color and appears to be constructed from geometric shapes, giving it a modern and somewhat abstract look. The hexagon provides a clear border around the 'T', making it stand out. The logo is simple, clean, and likely represents a company or organization whose name begins with the letter 'T'. TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTN - FRANCE