Latitude EV Total Elbow Arthroplasty

K171010 · Tornier, Inc. · JDB · Aug 31, 2017 · Orthopedic

Device Facts

• Record ID: K171010
• Device Name: Latitude EV Total Elbow Arthroplasty
• Applicant: Tornier, Inc.
• Product Code: JDB · Orthopedic
• Decision Date: Aug 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lattude EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where treatments or devices have failed; treatment of fractures that are unmanageable using other techniques. The Latitude EVIM Total Elbow Arthroplasty system is intended for cemented use only.

Device Story

Latitude EV Total Elbow Arthroplasty is a semi-constrained or constrained prosthetic system for total elbow replacement. It consists of humeral, ulnar, and optional radial implants. The device is implanted by orthopedic surgeons in a clinical/hospital setting. It functions by replacing the natural elbow joint to restore flexion/extension axis and kinematics. The system can be used as a 2-part (humeral/ulnar) or 3-part (humeral/ulnar/radial) construct; the radial component is optional. The device is intended for cemented fixation only. By replacing damaged joint surfaces, it aims to relieve pain, correct deformities, and restore function in patients with arthritis or complex fractures. Surgeons use the device to provide a stable, functional joint replacement.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including humeral and ulnar stem fatigue testing, ulnar cap modular connection static disassociation testing, and endotoxin testing (<20 EU/device).

Technological Characteristics

Metal/polymer semi-constrained cemented prosthesis. Components include humeral, ulnar, and optional radial implants. Humeral and ulnar stems feature plasma spray coating; radial implant is uncoated. Designed for cemented use only.

Indications for Use

Indicated for patients requiring total elbow arthroplasty to relieve severe pain or disability due to primary/secondary osteoarthritis, rheumatoid arthritis, functional deformities, failed prior treatments, or unmanageable fractures. Intended for cemented use only.

Regulatory Classification

Identification

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

Predicate Devices

• Latitude™ Elbow Prosthesis (K100562)
• Coonrad/Morrey Total Elbow (K053189)

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with a triple-line element above them, resembling a stylized caduceus without the snake.

Public Health Service

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

August 31, 2017

Tornier Inc. Renee Stoffel Sr. Regulatory Affairs Specialist 10801 Nesbitt Ave South Bloomington, Minnesota 55437

Re: K171010

Trade/Device Name: Latitude EVTM Total Elbow Arthroplasty Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDB, JDC Dated: August 2, 2017 Received: August 3, 2017

Dear Renee Stoffel:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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 (DICE) at its toll-free 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" (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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

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) K171010

Device Name Latitude EVTM Total Elbow Arthroplasty

### Indications for Use (Describe)

The Lattude EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The Latitude EVIM Total Elbow Arthroplasty system is 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) |

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# 510(k) Summary

Date Prepared: April 3, 2017

#### I. Administrative Information

| Name: | Tornier, Inc. |
|-----------------|---------------------------------------------------------------------------------|
| Address: | 10801 Nesbitt Avenue South<br>Bloomington, MN 55437<br>United States of America |
| Contact Person: | Renee Stoffel<br>Sr. Regulatory Affairs Specialist |
| Phone: | 952-683-7471 |
| Fax: | 952-426-7601 |

#### II. Device Information

| Name of Device: | Latitude EV TM Total Elbow Arthroplasty |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Elbow Prosthesis |
| Classification Name: | 21 CFR 888.3160, elbow joint metal/polymer semi-constrained cemented<br>prosthesis.<br>21 CFR 888.3150, elbow joint metal/polymer constrained cemented<br>prosthesis. |
| Regulatory Class: | Class II |
| Product Code: | JDB<br>JDC |

#### III. Predicate Device Information

Latitude™ Elbow Prosthesis, K100562 Primary Predicate: Additional Predicate: Coonrad/Morrey Total Elbow, K053189

#### IV. Device Description

The Latitude EV™ Total Elbow Arthroplasty system is a 2- or 3-part total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The Latitude EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the elbow. The prosthesis is a semi-constrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.

The Latitude EV™ humeral and ulnar stems are available in multiple sizes for primary and revision surgery and include a plasma spray coating. The optional radial implant is uncoated and is available in several sizes corresponding to the humeral and ulnar construct size selected.

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Image /page/4/Picture/1 description: The image shows the word "TORNIER" in a blue serif font. To the right of the word is a blue hexagon with a stylized letter "T" inside. The letter "T" is also blue and has a smaller hexagon around it.

#### V. Indications for Use

The Latitude EVTM Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The Latitude EVIM Total Elbow Arthroplasty system is intended for cemented use only.

#### VI. Comparison of Technological Characteristics with the Predicate Devices

The Latitude EVTM Total Elbow Arthroplasty system has the same intended use as the predicate devices. The humeral, ulnar, and optional radial implants are identical to those currently marketed in the Latitude EVTM Total Elbow Arthroplasty system (cleared as the Latitude™ Elbow Prosthesis, K100562). The purpose of this submission is to allow implantation of the Latitude EV prosthesis as a 2-part system consisting only of the humeral and ulnar implants. The radial implant will become optional. The two-part configuration is similar in function and design to the Coonrad/Morrey Total Elbow, K053189. The design differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or effectiveness.

#### VII. Performance Data

Non-clinical performance bench testing (mechanical testing) was performed to demonstrate substantial equivalence to the predicate device.

- . Humeral and Ulnar Stem Fatigue Testing
- Ulnar Cap Modular Connection Static Disassociation Testing
- Endotoxin (<20 EU/device)

#### VIII. Clinical Study

Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device.

#### IX. Conclusions

The Latitude EVTM system described in this section has the same intended use and the same fundamental scientific technology as the predicate devices. The testing presented for the technological differences between the subject and predicate devices demonstrate that the Latitude EV™ Total Elbow Arthroplasty system is substantially equivalent to the predicate devices.