INVISION Total Ankle Revision System

K180730 · Wrightmedicaltechnologyinc · HSN · Jul 11, 2018 · Orthopedic

Device Facts

• Record ID: K180730
• Device Name: INVISION Total Ankle Revision System
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HSN · Orthopedic
• Decision Date: Jul 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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

INVISION Total Ankle Revision System is a fixed-bearing ankle replacement prosthesis designed to restore mobility to failing ankle joints. The system consists of modular components including a tibial tray, talar domes, talar plates, and a poly insert, which are assembled into a two-piece prosthesis. Surgeons select component sizes and configurations based on patient anatomy. The device is implanted in a clinical setting by a surgeon to replace the flexion and extension movement of the ankle joint, reduce pain, and restore alignment. It serves as a revision system for patients with previous failed ankle surgeries or severe arthritis.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including fatigue, shear, and torsion testing, as well as pyrogen testing and MR safety labeling.

Technological Characteristics

Fixed-bearing ankle prosthesis. Materials: Plate (ASTM F136, ASTM F1580), Central/Locking Peg/Plug (ASTM F136). Peg head includes TiN coating. Modular design with multiple sizes and lengths. Cemented fixation.

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 (K171067)
• INVISION Total Ankle Revision System (K153008)
• INBONE Total Ankle System (K103374)
• INBONE Total Ankle System (K133585)

Reference Devices

• INBONE Total Ankle System (K10086)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Wright Medical Technology, Inc. Alayne Melancon Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

Re: K180730

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: May 25, 2018 Received: June 1, 2018

Dear Alayne Melancon:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

July 11, 2018

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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 comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

#### K180730

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, post-traumatic, or degenerative arthritis.

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

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

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> 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."

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# K180730 Page 1 of 2

Headquarters Wright Medical Technology, Inc.

1023 Cherry Road Memphis, TN 38117

901 867 9971
wmt.com

#### 510(k) SUMMARY

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) MANUFACTURER IDENTIFICATION

| Submitted By: | Wright Medical Technology, Inc.<br>1023 Cherry Road<br>Memphis, TN 38117 |
|-----------------|----------------------------------------------------------------------------------------------------|
| Date: | March 19, 2018 |
| Contact Person: | Alayne Melancon<br>Regulatory Affairs Specialist II<br>Office: [phone]<br>Fax: [phone] |

(a)(2) SUBJECT DEVICE INFORMATION

| Proprietary Name: | INVISION™ Total Ankle Revision System |
|----------------------------------|-------------------------------------------------------------------|
| Common Name: | Ankle Joint metal/polymer semi-constrained<br>cemented prosthesis |
| Classification Name & Reference: | 21 CFR 888.3110 - Class II |
| Device Product Code & Panel: | HSN - Orthopedic |

(a)(3) PREDICATE DEVICE INFORMATION

| INVISION Total Ankle Revision System – Primary Predicate | K171067 |
|----------------------------------------------------------|------------------|
| INVISION Total Ankle Revision System | K153008 |
| INBONE Total Ankle System | K103374, K133585 |

## (a)(4) DEVICE DESCRIPTON

The INVISION Total Ankle Revision System is a fixed-bearing ankle replacement prosthesis that restores mobility to a failing ankle joint. This modular system is comprised of a tibial tray, talar domes, talar plates, and a poly insert. These components are assembled together to create the two-piece prosthesis. Based on patient anatomy, a number of component sizes and design configurations can be selected.

# (a)(5) INTENDED USE

The 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

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 previous ankle surgery.

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

#### (a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON

The subject devices are talar fixation line extension components for the talar construct intended to be used with the existing INVISION Total Ankle Revision System talar domes. As such, the subject devices have identical intended use, indications for use, size offerings, and principles of operation to the predicates to maintain the modularity of the system. Table 1 below shows a comparison of technological characteristics.

| | SUBJECT | PREDICATES | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------|
| | INVISION Total Ankle<br>Revision System | INVISION Total Ankle<br>Revision System<br>- K171067, K153008 - | INBONE Total Ankle System<br>- K10086, K103374,<br>K133585 - |
| Material | Plate: ASTM F136, ASTM F1580<br>Central Peg/Plug: ASTM F136<br>Locking Peg/Plug: ASTM F136<br>+TiN ( <i>peg head only</i> ) | Plate: ASTM F136, ASTM<br>F1580 | Dome: ASTM F1537,<br>ASTMF1580<br>Central Stem: ASTM F136 |
| Plate Sizes | 1, 2, 3, 4, 5 | Identical | 1, 2, 3, 4, 5, 6 |
| Plate Length<br>Options | Standard and Long | Identical | N/A |
| Orientation | Left and Right | Identical | Universal |

#### Table 1 Subject vs Predicate Technological Comparison

### (b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE

The following evaluations were conducted to support the safety and efficacy of the INVISION Total Ankle Revision System:

- -Fatigue Testing
--

- Shear Testing
- Torsion Testing
- -Pyrogen
-
- MR Safety Labeling ।

(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A

#### (b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS

The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness and testing shows no new worst case. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.