PROPHECY INVISION Preoperative Navigation Alignment System

K162795 · Wrightmedicaltechnologyinc · HSN · Feb 22, 2017 · Orthopedic

Device Facts

• Record ID: K162795
• Device Name: PROPHECY INVISION Preoperative Navigation Alignment System
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HSN · Orthopedic
• Decision Date: Feb 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3110
• Device Class: Class 2

Intended Use

Wright's PROPHECY® Preoperative Navigation Alignment System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The PROPHECY® Preoperative Navigation Alignment Guides are intended for use with Wright's INBONE® and INFINITY® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Preoperative Navigation Alignment Guides are intended for single use only. The PROPHECY® Preoperative Reports are intended for use with Wright's INBONE", INFINITY" and INVISION® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

Device Story

System provides patient-specific surgical instrumentation and preoperative reports for total ankle replacement; utilizes patient imaging scans to generate templates of distal tibial and proximal talar anatomy; assists surgeons in intraoperative positioning of implants and bone marking; used in clinical settings by surgeons; reports serve as templates for traditional alignment; guides are single-use; system facilitates alignment for INBONE, INFINITY, and INVISION Total Ankle Systems; benefits include improved surgical planning and implant positioning accuracy.

Clinical Evidence

No clinical data. Bench testing only, including design repeatability and software validation.

Technological Characteristics

Patient-specific surgical instrumentation and preoperative reports. Materials and software identical to predicate devices. Single-use guides. Software-based preoperative navigation and alignment planning.

Indications for Use

Indicated for patients requiring total ankle replacement using INBONE, INFINITY, or INVISION systems where anatomic landmarks for alignment are identifiable on patient imaging scans.

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

• PROPHECY INBONE (K110306)
• PROPHECY INFINITY (K131283)
• INVISION Total Ankle System (K142117)
• INVISION Total Ankle System (K153008)

Submission Summary (Full Text)

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Image /page/0/Picture/1 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

February 22, 2017

Wright Medical Technology, Inc. Tara Conrad Regulatory Affairs Specialist II 1023 Cherry Road Memphis. Tennessee 37117

Re: K162795

Trade/Device Name: PROPHECY INVISION Preoperative Navigation Alignment System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN, OYK Dated: September 20, 2016 Received: October 4, 2016

Dear Tara Conrad:

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 devicerelated 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.

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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/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 at its toll-free number [phone] or [phone] or at its Internet address

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

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

510(k) Number (if known)

K162795

Device Name

PROPHECY® INVISION® Preoperative Navigation Alignment System

Indications for Use (Describe)

Wright's PROPHECY® Preoperative Navigation Alignment System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The PROPHECY® Preoperative Navigation Alignment Guides are intended for use with Wright's INBONE® and INFINITY® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Preoperative Navigation Alignment Guides are intended for single use only. The PROPHECY® Preoperative Reports are intended for use with Wright's INBONE", INFINITY" and INVISION® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

Type of Use (Select one or both, as applicable)

|×| 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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Headquarters Wright Medical Technology, Inc.

Memphis. TN 3811

901 867 9971
wtmt.com

Image /page/3/Picture/3 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.

## 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 PROPHECY® INVISION® Preoperative Navigation Alignment System.

| 1. | Submitted By: | Wright Medical Technology, Inc.<br>1023 Cherry Road<br>Memphis, TN 38117 |
|----|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | Date: | January 27, 2017 |
| | Contact Person: | Tara Conrad<br>Regulatory Affairs Specialist II<br>Office [phone]<br>Fax [phone] |
| 2. | Proprietary Name: | PROPHECY® INVISION® Preoperative<br>Navigation Alignment System |
| | Common Name: | Alignment Guide |
| | Classification Name and Reference: | 21 CFR 888.3110 - Class II |
| | Device Product Code, Device Panel: | HSN, OYK |
| 3. | Predicate Device: | K110306-PROPHECY® INBONE®<br>K131283-PROPHECY®INFINITY®<br>K142117-INVISION® Total Ankle System<br>K153008-INVISION® Total Ankle System |
| 4. | Device Description | |

PROPHECY® Preoperative Navigation Alignment System provides the surgeon a template of the patient's distal tibial and proximal talar anatomy. The PROPHECY® alignment report serves as a template for traditional alignmentation used with Wright's INBONE®, INFINITY , and INVISION® Total Ankle Systems.

#### ട. Intended Use and Indications for Use

Wright's PROPHECY® Preoperative Navigation Alignment System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the

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marking of bone before cutting. The PROPHECY® Preoperative Navigation Alignment Guides are intended for use with Wright's INBONE® and INFINITY® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Preoperative Navigation Alignment Guides are intended for single use only. The PROPHECY® Preoperative Reports are intended for use with Wright's INBONE®, INFINITY® and INVISION® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

#### 6. Technological Characteristics Comparison

The PROPHECY® Preoperative Navigation Alignment system has identical indications, is made from identical materials and software when compared to the legally marketed predicate devices.

#### 7. Substantial Equivalence- Non-Clinical Evidence

The main difference between the subject and predicate PROPHECY® systems is the addition of use with the INVISION® Total Ankle System. The following evaluations were conducted to support the safety and efficacy of the PROPHECY® INVISION® Alignment Report:

- Design repeatability across design engineers -
- -Software validation

These evaluations concluded the subject alignment guide is substantially equivalent to the predicates.

#### 8. Substantial Equivalence- Clinical Evidence

N/A

#### 9. Substantial Equivalence- Conclusions

The design characteristics of the subject devices 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 systems and are substantially equivalent.

b.