SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS

K130533 · Tornier S.A.S. · HSN · May 17, 2013 · Orthopedic

Device Facts

• Record ID: K130533
• Device Name: SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
• Applicant: Tornier S.A.S.
• Product Code: HSN · Orthopedic
• Decision Date: May 17, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Salto Talaris Total Ankle Prosthesis: The Salto Talaris Total Ankle Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. Components are intended for cemented use only. RHS: The RHS is intended for: 1) Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation visible on x-ray a. Resistance to conservative treatment b. 2) Primary replacement after fracture of the radial head 3) Symptomatic sequelae after radial head resection 4) Revision following failed radial head arthroplasty The long stem is for single cemented use only. The short stem coated with titanium plasma-spray is for single use with or without cement.

Device Story

Salto Talaris Total Ankle Prosthesis and RHS (Radial Head Prosthesis) are orthopedic joint replacement implants. Salto Talaris consists of a metal tibial base, polyethylene articulating insert, and metal talar resurfacing component; RHS consists of a metal radial stem and metal-polyethylene radial head. Devices are used by orthopedic surgeons in clinical settings to restore joint function and relieve pain. This submission introduces a new coating subcontractor (Eurocoating S.p.A) for titanium plasma-spray coating on cobalt chromium components. Implants are surgically implanted; fixation methods include cemented use (Salto Talaris, RHS long stem) or optional cementless use (RHS short stem).

Clinical Evidence

Bench testing only. Testing included shear fatigue strength, static shear strength, static tensile strength, abrasion, and coating characterization (thickness, pore size, and pore volume) to verify that the new coating subcontractor's process is equivalent to the predicate.

Technological Characteristics

Materials: Cobalt chromium alloy (ISO 5834-2, ISO 5832-7, ISO 5832-12) with titanium plasma-spray coating (ASTM F1580). Design: Semi-constrained anatomical. Fixation: Cemented or cementless (RHS short stem). Sterilization: Identical to predicate.

Indications for Use

Indicated for patients requiring total ankle replacement due to severe rheumatoid, posttraumatic, or degenerative arthritis (Salto Talaris). Indicated for patients requiring radial head replacement due to degenerative or post-traumatic disabilities (pain, crepitation, decreased motion), joint destruction/subluxation, fracture, sequelae after resection, or failed arthroplasty (RHS).

Regulatory Classification

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).

Predicate Devices

• Salto Talaris Total Ankle Prosthesis (K060544, K090076)
• Alvine Total Ankle Prosthesis (Agility) (K920802, K020541)
• Topez Total Ankle Replacement (K051023)
• Radial Head Prosthesis (K994041, K060438)
• Radial Head (Avanta) (K023604)
• Explor (Biomet) (K051385)

Submission Summary (Full Text)

{0}------------------------------------------------

# Implants Chirurg

MAY 1 7 2013

## Sto (K)Summary of Safety and Effectiveness information Special 510(k) Premarket Notification - Salto Talaris Total Ankle Prosthesis, RHS

Date prepared: May 17th 2013

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

#### 1) Device name

| Trade name: | Salto Talaris Total Ankle Prosthesis |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| Common name: | Total Ankle Prosthesis |
| Classification name: | Ankle joint metal/polymer semi-constrained cemented prosthesis |
| Trade name: | RHS |
| Common name: | Radial Head Prosthesis |
| Classification name: | Elbow joint radial (hemi-elbow) polymer prosthesis<br>Elbow joint metal/polymer semi-constrained cemented prosthesis |

### 2) Submitter

Tornier SAS 161, Rue Lavoisier 38330 Montbonnot Saint Martin - France

#### 3) Applicant

Tornier SAS 161, rue Lavoisier 38330 Montbonnot Saint Martin - France

#### 4) Company contact

Tornier SAS Mrs Séverine Bonneton Project Regulatory Affairs Coordinator 161, rue Lavoisier 38334 Montbonnot Cedex - France Tel: [phone] Fax: [phone] e-mail : severine.bonneton(a)tornier.com

TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : [phone] Fax : [phone]

Section 5 - Page 1/ page 4

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

{1}------------------------------------------------

#### 5) Classification

#### For the Salto Total Ankle Prosthesis:

Device class: Class II Classification panel: Orthopedic Product code: 87 HSN

#### For the RHS:

| Device class: | Class II |
|-----------------------|------------|
| Classification panel: | Orthopedic |
| Product code: | JDB & KWI |

#### 6) Equivalent / Predicate device

#### For the Salto Talaris Total Ankle Prosthesis:

Salto Talaris Total Ankle Prosthesis. Tornier, K060544, K090076 Alvine Total Ankle Prosthesis (Agility), DePuy, K920802, K020541 Topez Total Ankle Replacement, Topez Orthopedics, Inc., K051023

#### For the RHS:

Radial Head Prosthesis, Tornier, K994041, K060438 Radial Head, Avanta, K023604 Explor, Biomet, K051385

#### 7) Device description

#### For the Salto Talaris Total Ankle Prosthesis:

The goal of total ankle replacement is to restore function and relieve pain. The Salto Talaris Total Ankle Prosthesis is intended to accomplish these goals. The Salto Talaris Total Ankle Prosthesis is a semi-constrained anatomical design, which reproduces the kinematics of the ankle joint.

The Tornier Salto Talaris Total Ankle Prosthesis consists of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar resurfacing component.

#### For the RHS:

The RHS has been designed in order to provide surgeons and patients with a joint prosthesis to restore function and relieve pain of the radial part of the elbow joint. The RHS has an anatomical design, which reproduces the kinematics of the radial joint. The RHS consists of two components: a metal radial stem and a metal-polyethylene radial head.

Image /page/1/Picture/18 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is composed of thick, bold lines, with the top bar of the "T" being slightly wider than the vertical stem. The hexagon provides a clear, geometric border around the central letter, making the logo distinct and recognizable. The logo is black and white.

TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : [phone] Fax : [phone]

Section 5 - Page 2/ page 4

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

{2}------------------------------------------------

# Implants Chirurgicau

The present submission corresponds to the following modification:

- Addition of a new coating subcontractor (titanium coating): Eurocoating S.p.A on cobalt chromium components.
All the prostheses of this application are strictly identical to the previously cleared devices except for the coating supplier. The indications for use of each device are not modified.

#### 8) Materials (modified components)

#### For the Salto Talaris Total Ankle Prosthesis:

The tibial and the talar components are manufactured from cobalt chromium alloy (CoCr) according to ISO standard 5834-2.

The titanium coating conforms to the ASTM standard F1580.

#### For the RHS:

The short stem is manufactured from cobalt chromium alloy (CoCr) according to ISO standard 5832-7 or ISO 5832-12.

The titanium coating conforms to the ASTM standard F1580.

#### 9) Indications

#### Salto Talaris Total Ankle Prosthesis:

The Salto Talaris Total Ankle Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.

Components are intended for cemented use only.

#### RHS:

The RHS is intended for:

1) Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

- Joint destruction and/or subluxation visible on x-ray a.
- Resistance to conservative treatment b.

2) Primary replacement after fracture of the radial head

3) Symptomatic sequelae after radial head resection

4) Revision following failed radial head arthroplasty

The long stem is for single cemented use only. The short stem coated with titanium plasma-spray is for single use with or without cement.

Image /page/2/Picture/25 description: The image shows a logo with a stylized letter "T" inside of a hexagon. The "T" is bold and has a unique design, with the top part of the "T" appearing to be a separate, smaller "T" placed above the main stem. The logo is black and white, with the "T" being the most prominent feature within the hexagonal border.

TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : [phone] Fax : [phone] Section 5 - Page 3/ page 4

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

{3}------------------------------------------------

#### 10) Summary of technological characteristics

The only change to the cleared devices of the Salto Talaris Total Ankle Prosthesis and the RHS is the addition of a new coating subcontractor: Eurocoating S.p.A

The Eurocoating S.p.A coating has the same specifications currently requested from BioCoat Company: coating specification drawings as well as the intended use of the implants concerned are not modified compared to the already cleared devices.

Process specifications for the application of titanium coating have been provided in Eurocoating S.p.A Master File MAF 1989.

The indications for use, the other technical characteristics (design, materials, manufacturing, sizing, method of fixation) of the Sulto Talaris Total Ankle Prosthesis and the RHS are identical to the predicate devices. The covered zones of the implants concerned remain the same ones

### 11) Non-clinical testing & Substantial equivalence conclusion

Non-clinical testing (shear fatigue strength, static shear strength test, static tensile strength and abrasion) and coating characterization (thickness, pore size and pore volume) were performed to determinate substantial equivalence.

The design, the material, the sizes, the method of fixation and the sterilization process are identical for both devices whatever the coating subcontractor is.

The results of this evaluation allow us to conclude that the proposed new coating subcontractor Eurocoating S.p.A described in this submission does not induce any new or higher risk compared to the predicate coating subcontractor BioCoat Company and therefore both coating subcontractors (proposed and predicate) are substantially equivalent.

Image /page/3/Picture/11 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is composed of thick lines and has a slightly ornate design. The hexagon provides a clear, geometric border around the letter, making it stand out.

TORNIER S.A.S. 161. rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : [phone] Fax : [phone]

Section 5 - Page 4/ page 4 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

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Letter dated: May 17, 2013

Tornier SAS % Ms. Séverine Bonneton Project Regulatory Affairs Coordinator 161, Rue Lavoisier 38330 Montbonnot Saint Martin France

Re: K130533

Trade/Device Name: Salto Talaris Total Ankle Prosthesis RHS Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSN, JDB, KWI Dated: April 18, 2013 Received: April 19, 2013

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 Part 801); medical device reporting (reporting of medical

{5}------------------------------------------------

Page 2 - Ms. Severine Bonneton

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark Newlelkerson -S

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

Enclosure

{6}------------------------------------------------

## Indications for Use

### 510(k) Number (if known): K130533

Device Name: Salto Talaris Total Ankle Prosthesis RHS

#### Indications For Use:

#### Salto Talaris Total Ankle Prosthesis:

The Salto Talaris Total Ankle Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.

Components are intended for cemented use only.

#### RHS:

The RHS is intended for:

l) Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with:

Joint destruction and/or subluxation visible on x-ray a.

b. Resistance to conservative treatment

2) Primary replacement after fracture of the radial head

3) Symptomatic sequelae after radial head resection

4) Revision following failed radial head arthroplasty

The long stem is for single cemented use only. The short stem coated with titanium plasma-spray is for single use with or without cement.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/6/Picture/22 description: The image contains the text "Casey L. Hanley, Ph.D." above a horizontal line. Below the line, the text "Division of Orthopedic Devices" is present. There is also a logo above the text, which appears to be a stylized design.