INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM

K141740 · Wrightmedicaltechnologyinc · HSN · Mar 5, 2015 · Orthopedic

Device Facts

• Record ID: K141740
• Device Name: INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HSN · Orthopedic
• Decision Date: Mar 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inbone® and Infinity Total Ankle Systems are 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

The INBONE and INFINITY Total Ankle Systems are semi-constrained cemented ankle prostheses. The system comprises modular tibial trays (titanium alloy), talar domes (cobalt chrome), and tibial inserts (UHMWPE). The device is implanted by a surgeon to replace the ankle joint, aiming to reduce pain, restore alignment, and restore flexion/extension movement. The subject submission updates the Instructions for Use to include MR Conditional labeling based on non-clinical testing regarding radio frequency heating and magnetically induced displacement. No design modifications were made to the implants themselves.

Clinical Evidence

No clinical data provided (N/A).

Technological Characteristics

Semi-constrained cemented ankle prosthesis. Materials: Titanium alloy (tibial trays), cobalt chrome (talar domes), and UHMWPE (tibial inserts). Modular stem connections. 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. 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

• Inbone® II Total Ankle System (K123059)
• Infinity® Total Ankle System (K123954)
• Infinity® Total Ankle System (K140749)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

Wright Medical Technology, Incorporated Ms. Jeanine Redden Director, Regulatory Affairs 1023 Cherry Road Memphis, Tennessee 38117

March 5, 2015

Re: K141740

Trade/Device Name: INBONE and INFINITY Total Ankle 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: January 17, 2015 Received: February 3, 2015

Dear Ms. Redden:

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

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Page 2 - Ms. Jeanine Redden

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

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

Sincerely vours.

# 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

510(k) Number (if known)

K141740

Device Name INBONE and INFINITY Total Ankle System

Indications for Use (Describe)

The INBONE and INFINITY Total Ankle is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

The INBONE and INFINITY Total Ankle is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: 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)

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Image /page/4/Picture/0 description: The image shows the logo for Wright focused excellence. The logo has a geometric shape on the left, followed by the word "WRIGHT" in bold, uppercase letters. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in smaller, uppercase letters.

Wright Medical Technology, Inc.

1023 Cherry Road Memphis, TN 38117

www.wmt.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 INBONE® and INFINITY® Total Ankle Systems.

| (a)(1). Submitted By: | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
|------------------------------------|-----------------------------------------------------------------------------------------|
| Date: | March 4, 2015 |
| Contact Person: | Jeanine Redden Director, Regulatory Affairs Office [phone] Fax [phone] |
| (a)(2). Proprietary Name: | Inbone® Total Ankle System; Infinity® Total Ankle System |
| Common Name: | Total Ankle System |
| Classification Name and Reference: | 21 CFR 888.3110 - Class II |
| Device Product Code, Device Panel: | HSN - Orthopedic |
| (a)(3). Predicate Device: | K123059 Inbone® II Total Ankle System K123954 and K140749 Infinity® Total Ankle System |

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

The Inbone® and Infinity® Total Ankle Systems consist of tibial trays, talar domes and tibial inserts. The tibial trays and talar domes have modular stem connections. The tibial trays are manufactured from titanium alloy; the talar domes are manufactured from cobalt chrome; and the tibial inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE).

The Inbone® and Infinity® Total Ankle Systems are intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

The design features of the Inbone® and Infinity® Total Ankle Systems are substantially equivalent to the design features of other-devices previously cleared for market.

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## (a)(5). Intended Use

The Inbone® and Infinity Total Ankle Systems are intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

## Indications for Use

The Inbone and Infinity Total Ankle Systems are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

The Inbone® and Infinity® Total Ankle Systems are additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The ankle prosthesis is intended for cement use only.

The indications are similar to the legally marketed predicate device.

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

No design modifications are being made to the subject Inbone® and Infinity® Total Ankle Systems. Modification of the Instructions For Use (IFU) were made include a statement regarding the compatibility of the device with MR environments.

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

Testing in a MR environment has found that the subject device poses minimal risk under labeled conditions of use with regard to radio frequency heating or magnetically induced displacement.

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

N/A

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

As no design changes are being made to the subject device, the design characteristics of the subject device does not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k) regarding testing in a MR environment, the subject device is expected to pose minimal risk under labeled conditions of use to patients when place in an MR environment and is categorized as MR Conditional.