INVISION Total Ankle Revision System

K171067 · Wrightmedicaltechnologyinc · HSN · Sep 11, 2017 · Orthopedic

Device Facts

• Record ID: K171067
• Device Name: INVISION Total Ankle Revision System
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HSN · Orthopedic
• Decision Date: Sep 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

INVISION Total Ankle Revision System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

Device Story

Fixed-bearing ankle replacement prosthesis; restores mobility to failing ankle joints. System comprises multiple tibial and talar components assembled into a two-piece prosthesis; selected based on patient anatomy for optimal fit. Used by orthopedic surgeons in clinical settings to replace flexion/extension movement, reduce pain, and restore alignment in damaged ankle joints. Subject device features thicker talar domes and talar plates with additional peg sizes/orientations compared to predicates. Device is MR Conditional.

Clinical Evidence

No clinical data.

Technological Characteristics

Fixed-bearing ankle prosthesis; two-piece design with tibial and talar components. Materials, instrumentation, and sterilization methods are identical to predicate devices. Categorized as MR Conditional.

Indications for Use

Indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis, or patients with a failed previous ankle surgery. In the US, intended for cement use only.

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

• INVISION Total Ankle Revision System (K142117)
• INVISION Total Ankle Revision System (K153008)
• INBONE and INFINITY Total Ankle Systems (K141740)

Submission Summary (Full Text)

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Image /page/0/Picture/2 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 human profiles facing to the right, stacked on top of each other.

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

Wright Medical Technology, Inc. Val Myles Regulatory Affairs Specialist 1023 Cherry Road Memphis. Tennessee 38117

September 11, 2017

Re: K171067

Trade/Device Name: INVISION™ Total Ankle Revision 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: July 20, 2017 Received: July 25, 2017

Dear Ms. Myles:

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

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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 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K171067

Device Name

INVISION™ Total Ankle Revision System

#### Indications for Use (Describe)

The INVISION Total Ankle Revision System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.

The INVISION Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: In the United States, the ankle prosthesis is intended for cement 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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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Image /page/4/Picture/1 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, on the left side of the word "WRIGHT" in red, block letters. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray font.

1023 Cherry Road Memphis, TN 38117 wright.com

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the INVISION™ Total Ankle Revision System.

| (a)(1). Submitted By: | Wright Medical Technology, Inc.<br>1023 Cherry Road<br>Memphis, TN 38117 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Date: | March 31, 2017 |
| Contact Person: | Val Myles<br>Regulatory Affairs Specialist<br>Office [phone]<br>Fax [phone] |
| (a)(2). Proprietary Name: | INVISIONTM Total Ankle Revision System |
| Common Name: | Total Ankle Prosthesis |
| Classification Name and Reference: | 21 CFR 888.3110 - Class II |
| Device Product Code, Device Panel: | HSN - Orthopedic |
| (a)(3). Predicate Device: | K142117, K153008 - INVISION Total Ankle<br>Revision System<br>K141740 - INBONE and INFINITY Total Ankle<br>Systems |

#### (a)(4). Device Description

The INVISION Total Ankle Revision System is a fixed-bearing ankle replacement prosthesis that restores mobility to a failing ankle joint. The system includes multiple tibial and talar components that are assembled together to create the two-piece prosthesis. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

#### (a)(5). Intended Use

INVISION Total Ankle Revision System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

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## Indications for Use

previous ankle surgery.

The INVISION Total Ankle Revision System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The INVISION Total Ankle Revision System is additionally indicated for patients with a failed

CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

## (a)(6). Technological Characteristics Comparison

The subject INVISION Total Ankle System includes thicker talar domes and talar plates with additional peg sizes and orientations. The subject system has identical indications, utilizes similar instrumentation, is made from identical materials, and has identical sterilization methods when compared to the legally marketed predicate devices. Labeling modifications include a statement regarding the compatibility of the device with MR environments and contraindication updates.

## (b)(1). Substantial Equivalence- Non-Clinical Evidence

Engineering analysis and rationale was performed to demonstrate substantial equivalence in shear strength, fatigue strength, and torsional stability. MR testing and analysis related to displacement force, torque, artifact, RF heating testing were also used to demonstrate substantial equivalence. Pyrogenicity testing was also conducted.

#### (b)(2). Substantial Equivalence- Clinical Evidence

N/A

#### (b)(3). Substantial Equivalence- Conclusions

The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate devices. In addition, the subject device is expected to pose minimal risk to patients when place in an MR environment and is categorized as MR Conditional.