PROPHECY INVISION Pre-operative Navigation System

K170968 · Wrightmedicaltechnologyinc · HSN · Aug 16, 2017 · Orthopedic

Device Facts

• Record ID: K170968
• Device Name: PROPHECY INVISION Pre-operative Navigation System
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HSN · Orthopedic
• Decision Date: Aug 16, 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™, 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. 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 uses patient imaging scans to create patient-specific surgical guides; guides fit anatomy of distal tibia and proximal talus; assists surgeons in positioning total ankle replacement components and marking bone for cutting; used intraoperatively; guides are single-use; reports provide preoperative planning data; system facilitates accurate implant alignment; benefits patient through improved surgical precision and implant placement.

Clinical Evidence

No clinical data provided. Evidence is based on non-clinical bench testing, including guide design process validation, designer repeatability, pre-operative vs. post-operative analysis of implant placement, and guide placement repeatability/inter-surgeon variability.

Technological Characteristics

Patient-specific guides constructed from Duraform Polyamide; accessory instruments made of stainless steel and Radel. System utilizes patient imaging for custom guide fabrication. Software-driven preoperative planning and navigation. Single-use guides.

Indications for Use

Indicated for patients undergoing total ankle replacement with INBONE, INFINITY, or INVISION systems where anatomic landmarks for implant 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 INVISION Pre-operative Navigation Alignment System (K162795)
• PROPHECY INFINITY Pre-operative Navigation Alignment System (K131283)
• PROPHECY INBONE Pre-operative Navigation Alignment System (K110360)

Reference Devices

• INVISION Total Ankle System (K142117, K153008)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

August 16, 2017

Re: K170968

Trade/Device Name: PROPHECY INVISION Pre-operative Navigation 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: March 24, 2017 Received: March 31, 2017

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 (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 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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# Indications for Use

510(k) Number (if known)

#### K170968

# Device Name

PROPHECY™ INVISION™ Preoperative Navigation 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™, 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. 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)

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

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#### K170968 Page 1 of 3

Headquarters Wright Medical Technology, Inc.

1023 Cherry Road Memphis, TN 38117

901 867 9971 vmt.com

Image /page/4/Picture/4 description: The image contains the logo for Wright National Flood Insurance Services, LLC. The logo consists of two overlapping trapezoids, one red and one orange, to the left of the word "WRIGHT" in red, block letters. Below the company name is the phrase "FOCUSED EXCELLENCE" in gray, sans-serif font.

#### 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 PROPHECY INVISION Pre-operative Navigation System.

## (a)(1) MANUFACTURER IDENTIFICATION

Submitted By:

Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117

Date:

March 24, 2017

Contact Person:

Alayne Melancon Regulatory Affairs Specialist Office: [phone] Fax: [phone]

# (a)(2) SUBJECT DEVICE INFORMATION

| Proprietary Name: | PROPHECY INVISION Pre-operative Navigation System |
|----------------------------------|---------------------------------------------------|
| Common Name: | Alignment Guide |
| Classification Name & Reference: | 21 CFR 888.3110 - Class II |
| Device Product Code & Panel: | HSN, OYK – Orthopedic |

# (a)(3) PREDICATE DEVICE INFORMATION

| PROPHECY INVISION Pre-operative Navigation Alignment System: | K162795 |
|--------------------------------------------------------------|------------------|
| PROPHECY INFINITY Pre-operative Navigation Alignment System: | K131283 |
| PROPHECY INBONE Pre-operative Navigation Alignment System: | K110360 |
| INVISION Total Ankle System: | K142117, K153008 |

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#### (a)(4) DEVICE DESCRIPTON

Wright Medical's PROPHECY INVISION Preoperative Navigation Alignment System (K162795) is being expanded to include patient-specific guides for the INVISION Total Ankle System. Like the predicates PROPHECY INFINITY and PROPHECY INBONE guides, the subject patient-specific guides are created to fit the anatomy of the patient's distal tibia and proximal talus, and when used in combination with the reusable instruments, facilitate positioning of INVISION Total Ankle Implants.

## (a)(5) 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™, 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. 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.

## (a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON

The subject PROPHECY INVISION Pre-operative Navigation System has identical indications and software components. The materials and design are substantially equivalent to the predicate devices and are summarized in the table below.

| | SUBJECT | PREDICATES | |
|----------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| | PROPHECY INVISION | PROPHECY INFINITY<br>(K131283) | PROPHECY INBONE<br>(K110360) |
| Patient-Specific<br>Guides | -Tibia Alignment -Guide<br>-Tibia Spacer Guide<br>-Talus Spacer Guide<br>-Tibia Stem Guide | -Tibia Alignment Guide<br>-Talus Alignment Guide | -Tibia Alignment Guide<br>-Talus Alignment Guide<br>-Tibia Stem Guide |
| Materials | Patient-specific guides:<br>Duraform Polyamide<br>Accessory instrument:<br>stainless steel, Radel | Patient-specific guides:<br>Duraform Polyamide<br>Accessory instrument:<br>stainless steel | Patient-specific guides:<br>Duraform Polyamide<br>Accessory instrument:<br>stainless steel |

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

The following evaluations were conducted to support the safety and efficacy of the PROPHECY INVISION Pre-operative Navigation System:

- Guide Design Process Validation Designer Repeatability

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- -Pre-operative vs Post-operative Analysis of Implant Placement
- Guide Placement Repeatability Inter-surgeon Variability -

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

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

The design characteristics of the subject device 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.