PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES

K110360 · Wrightmedicaltechnologyinc · HSN · Dec 16, 2011 · Orthopedic

Device Facts

• Record ID: K110360
• Device Name: PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HSN · Orthopedic
• Decision Date: Dec 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3110
• Device Class: Class 2

Intended Use

Wright's PROPHECY® INBONE® Pre-Operative 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 guiding the marking of bone before cutting. The PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are intended for use with Wright's INBONE® 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® INBONE® Pre-Operative Navigation Alignment Guides are intended for single use only.

Device Story

Patient-specific surgical guides designed from patient CT imaging data; manufactured from biocompatible nylon. Used intra-operatively by surgeons to assist in positioning total ankle replacement components and marking bone prior to cutting. Replaces traditional alignment instrumentation to reduce surgical steps. Guides fit distal tibial and proximal talar anatomy. Benefits include improved alignment accuracy and procedural efficiency. Output is physical guide used for bone marking and implant positioning.

Clinical Evidence

Bench testing only. Evidence includes repeatability testing across design engineers, guide placement repeatability testing, and cadaver testing by end users to analyze placement location and orientation.

Technological Characteristics

Patient-specific guides; material: biocompatible nylon; form factor: custom-fit to patient distal tibial and proximal talar anatomy; single-use; non-sterile (implied by surgical use context); design derived from CT imaging data via proprietary design algorithm.

Indications for Use

Indicated for patients undergoing total ankle replacement using the INBONE Total Ankle System, where anatomic landmarks for implant alignment are identifiable on patient 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

• INBONE® Total Ankle Replacement (K051023)

Submission Summary (Full Text)

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DEC 1 6 2011

K110360 '1/2

Create Motion.

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# 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 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides.

| Submitted By: | Wright Medical Technology, Inc.<br>5677 Airline Rd.<br>Arlington, TN 38002 |
|-------------------------------------|-----------------------------------------------------------------------------------------------|
| Date: | December 12, 2011 |
| Contact Person: | Sarah Holtgrewe<br>Manager, Regulatory Affairs<br>[phone] |
| Proprietary Name: | PROPHECY® INBONE® Pre-Operative<br>Navigation Alignment Guides |
| Common Name: | Alignment Guides |
| Classification Name and Reference: | 21 CFR 888.3110--Ankle joint metal/polymer semi-<br>constrained cemented prosthesis--Class II |
| Device Product Code and Panel Code: | Orthopedics/87/ HSN, OYK |
| Predicate Devices: | INBONE® Total Ankle Replacement (K051023) |

#### headquarters 5677 Airline Road Arlington, TN 38002 9901.867.9971 phone www.wmt.com Wright Medical Technology, Inc. international subsidiaries 011.33.1.45.13.24.40 France 011.49.211.862.9990 Germany 905.826.1600 Canada 011.32.3.378.39.05 Belgium 011.44.1483.721.404 UK 011.81.3.3538.0474 Japan 011.39.0260.678.227 Italy

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## DEVICE INFORMATION

## A. DEVICE DESCRIPTION

PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides 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® Total Ankle System, and thereby reduce the overall number of surgical steps required during total ankle arthroplasty. The guides serve to position and align the INBONE® implants in a comparable position to that attainable with traditional INBONE® instrumentation.

#### B. INTENDED USE

Wright's PROPHECY® INBONE® Pre-Operative 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 guiding the marking of bone before cutting. The PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are intended for use with Wright's INBONE® 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® INBONE® Pre-Operative Navigation Alignment Guides are intended for single use only.

## C. PERFORMANCE DATA

The following performance data was used to support the safety and efficacy of the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides:

- Repeatability testing across design engineers .
- Guide placement repeatability testing .
- . Cadaver testing by end users analyzing placement location and orientation
- Detailed software descriptions and documentation ●

### D. SUBSTANTIAL EQUIVALENCE INFORMATION

The main differences between the subject and predicate INBONE® system are in the patientspecific design and materials. The safety and efficacy of the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this 510(k), including the following: a device design algorithm to illustrate the PROPHECY® INBONE® design goal, a comparison with traditional surgical technique, and user repeatability testing and cadaver testing to ensure repeatability of design algorithm execution.

| headquarters<br>Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 | | 901.867.9971 phone | www.wmt.com | | |
|----------------------------------------------------------------------------------------------|-------------------------------------------------|--------------------|-------------------------------------------------------|-----------------------------|--|
| <i>international subsidiaries</i><br>011.32.3.378.39.05 Belgium<br>011.39.0250.678.227 Italy | 905.826.1600 Canada<br>011.81.3.3538.0474 Japan | | 011.33.1.45.13.24.40 France<br>011.44.1483.721.404 UK | 011.49.211.862.9990 Germany | |

K110360

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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 stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

2. Posted

. ... ..

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

Wright Medical Technology, Inc. % Ms. Sarah Holtgrewe 5677 Airline Road Arlington, TN 38002

DEC 1 6 2011

Re: K110360

K 10200
Trade/Device Name: PROPHECY INBONE Pre-Operative Navigation Alignment Guides Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HSN, OYK Dated: September 29, 2011 Received: September 30, 2011

Dear Ms. Holtgrewe:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 3 ro(t) premeine is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard management date of the Medical Device American Prus commence provision of May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices had have been roomstilled in approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The I ou may, incretore, market the device, babyer of the courements for annual registration, listing of general connois provisions of the field ing, and prohibitions against misbranding and ac vices, good manufacturing practice, and evaluate information related to contract liability adulteration. Tease note: ODTET assement 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 your device is classifica (300 above) interest major regulations affecting your device can be
it may be subject to additional controls. Existing major 1999 it may be subject to additional controlor simoning might of any of the 21, In addition, FDA may found in the Code of I caeral regarants in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuance of a bacevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that I DA has made a decertifications administered by other Federal agencies. You must of ally it ederal statures and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: registration an comply with an the Act 3 requirements, more and so the reporting (reporting of medical

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Page 2 - Ms. Sarah Holtgrewe

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin Keith

ForMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

# 510(k) Number (if known): |< \\0360

Device Name: PROPHECY® Pre-Operative Navigation Alignment Guides

Indications For Use:

Wright's PROPHECY® INBONE® Pre-Operative 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 guiding the marking of bone before cutting. The PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are intended for use with Wright's INBONE® 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® INBONE® Pre-Operative Navigation Alignment Guides are intended for single use only.

Prescription Use XXX (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)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K110360 510(k) Number_