PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES

K131283 · Wrightmedicaltechnologyinc · HSN · Jul 5, 2013 · Orthopedic

Device Facts

• Record ID: K131283
• Device Name: PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HSN · Orthopedic
• Decision Date: Jul 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3110
• Device Class: Class 2

Intended Use

Wright's PROPHECY® Preoperative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intra-operatively and in quiding 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.

Device Story

Patient-specific surgical guides; manufactured from preoperative CT imaging data; designed to fit distal tibial and proximal talar anatomy. Used intra-operatively by surgeons to assist in positioning total ankle replacement components and marking bone for cutting. Serves as alternative to traditional alignment instrumentation; reduces surgical steps. Biocompatible nylon construction. Single-use. Benefit: improved implant alignment and procedural efficiency.

Clinical Evidence

No clinical data. Evidence consists of bench testing: guide design repeatability, guide placement repeatability, and cadaver evaluation by end users to analyze placement location and orientation, plus software validation.

Technological Characteristics

Patient-specific guides; biocompatible nylon; manufactured from CT imaging data. Single-use. Software-driven design process. No active energy source.

Indications for Use

Indicated for patients undergoing total ankle replacement using Wright's INBONE® or INFINITY™ Total Ankle Systems, where anatomic landmarks for implant positioning are identifiable on preoperative CT 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® Preoperative Alignment Guides (K110360)
• INFINITY™ Total Ankle System (K123954)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in all capital letters. Below the word is a stylized graphic that resembles a "W". The graphic is black and has a textured appearance.

#### JUL 0 5 2013 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® INFINITY™ Preoperative Navigation Alignment Guides.

| Submitted By: | Wright Medical Technology, Inc.<br>5677 Airline Rd, Arlington TN, 38002<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Date: | May 3, 2013 |
| Contact Person: | Danielle Mueller<br>Project Manager Regulatory Affairs |
| Proprietary Name: | PROPHECY® INFINITY™ Preoperative Navigation<br>Alignment Guides |
| Common Name: | Alignment Guides |
| Classification Name and Reference: | 21 CFR 888.3110 Ankle joint metal/polymer<br>semi-constrained cemented prosthesis Class II |
| Subject Product Code and Panel Code: | Orthopedics/87/ HSN, OYK |
| Predicate Devices: | PROPHECY® INBONE® Preoperative Alignment<br>Guides [K110360]<br>INFINITY™ Total Ankle System [K123954] |

## DEVICE INFORMATION

## A. Intended Use

Wright's PROPHECY® Preoperative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intra-operatively and in quiding 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.

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## B. Device Description

PROPHECY® Preoperative Navigation Alignment Guides are patient-specific quides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The quides are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The PROPHECY® Guides serve as an alternative to traditional alignment instrumentation used with Wright's INBONE® and INFINITY™ Total Ankle Systems, and thereby reduce the overall number of surgical steps reguired during total ankle arthroplasty. The quides serve to position and align the implants comparable to that attainable with traditional instrumentation.

The following evaluations were conducted to support the safety and efficacy of the PROPHECY® INFINITY™ quides:

- Guide design repeatability across design engineers ।
- -Guide placement repeatability
- . Cadaver evaluation by end users analyzing placement location and orientation
- Software validation

These evaluations concluded the subject alignment quides are substantially equivalent to the predicates.

# C. Substantial Equivalence Information

The main difference between the subject and predicate PROPHECY® guides is the addition of use with the INFINITY™ Total Ankle System. The design features and materials of the subject devices are substantially equivalent to those of the predicates. The fundamental scientific technology has not changed relative to the predicate devices. The safety and efficacy of the PROPHECY® quides are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification.

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Image /page/2/Picture/0 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

July 5, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

Wright Medical Technology, Incorporated % Ms. Danielle Mueller Project Manager, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002

Re: K131283

Trade/Device Name: PROPHECY® INFINITY™ Preoperative Navigation Alignment Guides 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: May 3, 2013 Received: May 6, 2013

Dear Ms. Mueller:

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. Iisting 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

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### Page 2 - Ms. Danielle Mueller

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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, plcase 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/Safcty/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.htm.

Sincerely yours,

# 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): K131283

Device Name: PROPHECY® INFINITY™ Preoperative Navigation Alignment Guides

Indications For Use:

Wright's PROPHECY® Preoperative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in quiding 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.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

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