K Number
K103598
Device Name
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
Date Cleared
2011-10-17

(313 days)

Product Code
Regulation Number
888.3565
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wright's PROPHECY® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with Wright's ADVANCE® and EVOLUTION™ Total Knee 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® Pre-Operative Navigation Alignment Guides are intended for single use only.
Device Description
PROPHECY® Pre-Operative Navigation Alignment Guides are patient-specific guides created to fit the contours of the patient's distal femoral and tibial plateau anatomy. The guides are designed and manufactured from patient imaging data (MRI, CT), and are available in two versions: alignment and alignment and resection. The guides are made from biocompatible nylon, and the resection slots are biocompatible stainless steel. The PROPHECY® Guides serve as a alternative to traditional alignment instrumentation used with Wright's ADVANCE® and EVOLUTION™ Total Knee Systems, and thereby reduce the overall number of surgical steps required during total knee arthroplasty. The guides serve to position and align the ADVANCE® or EVOLUTION™ implants in a comparable position to traditional instrumentation.
More Information

Not Found

No
The description focuses on patient-specific guides created from imaging data (MRI, CT) and does not mention AI or ML in the design or function. The process described is based on anatomical landmarks and traditional alignment principles, not learning algorithms.

No
The device is described as surgical instrumentation/guides used to assist in the positioning of total knee replacement components and guiding the marking of bone before cutting. It is for intra-operative use and does not perform a therapeutic function on its own.

No

Explanation: The device is described as patient-specific surgical instrumentation intended to assist in the positioning of total knee replacement components and guiding the marking of bone before cutting. It is a tool for surgical alignment and resection, not for diagnosing a condition.

No

The device description explicitly states the guides are made from biocompatible nylon and stainless steel, indicating they are physical hardware components, not solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is used as "patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting." This describes a surgical tool used during a procedure, not a device used to perform tests on samples taken from the body to diagnose or monitor a condition.
  • Device Description: The description reinforces this by explaining that the guides are "patient-specific guides created to fit the contours of the patient's distal femoral and tibial plateau anatomy" and serve as an "alternative to traditional alignment instrumentation used with Wright's ADVANCE® and EVOLUTION™ Total Knee Systems." This further emphasizes its role as a surgical aid.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests to detect diseases or conditions, or providing diagnostic information based on laboratory analysis.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) during surgery.

N/A

Intended Use / Indications for Use

Wright's PROPHECY® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with Wright's ADVANCE® and EVOLUTION™ Total Knee 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® Pre-Operative Navigation Alignment Guides are intended for single use only.

Product codes (comma separated list FDA assigned to the subject device)

MBH, JWH, OOG

Device Description

PROPHECY® Pre-Operative Navigation Alignment Guides are patient-specific guides created to fit the contours of the patient's distal femoral and tibial plateau anatomy. The guides are designed and manufactured from patient imaging data (MRI, CT), and are available in two versions: alignment and alignment and resection. The guides are made from biocompatible nylon, and the resection slots are biocompatible stainless steel. The PROPHECY® Guides serve as a alternative to traditional alignment instrumentation used with Wright's ADVANCE® and EVOLUTION™ Total Knee Systems, and thereby reduce the overall number of surgical steps required during total knee arthroplasty. The guides serve to position and align the ADVANCE® or EVOLUTION™ implants in a comparable position to traditional instrumentation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MRI, CT

Anatomical Site

distal femoral and tibial plateau anatomy (for total knee replacement)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

surgeons (implied by "surgical instrumentation," "intra-operatively")

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

  • Cadaver testing by end users analyzing placement location and orientation .
  • . Repeatability testing across design engineers
  • Detailed software descriptions and documentation

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K093405

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

0

OCT 1 7 2011

Create Motion.+

Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized design that resembles a stylized "W". The design is composed of two diagonal lines that intersect in the middle, with a small dot below the intersection.

K10359B ( 1/2

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 PROPHECY® Pre-Operative Navigation Alignment Guides.

| Submitted By: | Wright Medical Technology, Inc.
5677 Airline Rd.
Arlington, TN 38002 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Date: | December 7, 2010 |
| Contact Person: | Sarah Holtgrewe
Manager, Regulatory Affairs |
| Proprietary Name: | PROPHECY® Pre-Operative Navigation
Alignment Guides |
| Common Name: | Alignment and Resection Guides |
| Classification Name and Reference: | 21 CFR 888.3565 --Knee joint patellofemorotibial
metal/polymer porous-coated uncemented
prosthesis--Class II |
| | 21 CFR 888.3560 --Knee joint patellofemorotibial
polymer/metal/polymer/semi-constrained cemented
prosthesis--Class II |
| Device Product Code and Panel Code: | Orthopedics/87/ MBH, JWH, OOG |
| Predicate Device | PROPHECY® Pre-Operative Navigation
Alignment Guides
(K093405) |

headquarters

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone

international subsidiaries 011.32.3.378.39.05 Belgium 011.39.0250.678.227 Italy

905.826.1600 Canada 011.81.3.3538.0474 Japan

011.33.1.45.13.24.40 France 011.44.1483.721.404 UK

www.wmt.com

011.49.211.862.9990 Germany

1

DEVICE INFORMATION

A. DEVICE DESCRIPTION

PROPHECY® Pre-Operative Navigation Alignment Guides are patient-specific guides created to fit the contours of the patient's distal femoral and tibial plateau anatomy. The guides are designed and manufactured from patient imaging data (MRI, CT), and are available in two versions: alignment and alignment and resection. The guides are made from biocompatible nylon, and the resection slots are biocompatible stainless steel. The PROPHECY® Guides serve as a alternative to traditional alignment instrumentation used with Wright's ADVANCE® and EVOLUTION™ Total Knee Systems, and thereby reduce the overall number of surgical steps required during total knee arthroplasty. The guides serve to position and align the ADVANCE® or EVOLUTION™ implants in a comparable position to traditional instrumentation.

B. INTENDED USE

Wright's PROPHECY® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with Wright's ADVANCE® and EVOLUTION™ Total Knee 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® 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® Pre-Operative Navigation Alignment Guides:

  • Cadaver testing by end users analyzing placement location and orientation .
  • . Repeatability testing across design engineers
  • Detailed software descriptions and documentation �

D. SUBSTANTIAL EQUIVALENCE INFORMATION

The main difference between the subject and predicate devices is in the addition of the EVOLUTION™ knee system to the indications for use. The safety and efficacy of the PROPHECY® Pre-Operative Navigation Alignment Guides are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this 510(k).

headquarters

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone

www.wmt.com

international subsidiaries 011.32.3.378.39.05 Belgium 011.39.0250.678.227 Italy

905.826.1600 Canada
011.81.3.3538.0474 Japan

011.33.1.45.13.24.40 France 11.44.1483,721.404 UK

011.49.211.862.9990 Germany

2

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

Wright Medical Technology, Inc. c/o Ms. Sarah Holtgrewe Regulatory Affairs Project Specialist 5677 Airline Road Arlington, Tennessee 38002

OCT 1 7 2011

Re: K103598

Trade/Device Name: Prophecy Pre-Operative Navigation Alignment Guides Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH, OOG 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 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.

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

3

Page 2 - Ms. Sarah Holtgrewe

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/CDRH/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Erin Keith

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

Enclosure

4

Indications for Use

510(k) Number (if known): K | 03598

Device Name: PROPHECY® Pre-Operative Navigation Alignment Guides

Indications For Use:

Wright's PROPHECY® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with Wright's ADVANCE® and EVOLUTION™ Total Knee 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® 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)

1 of 1

Michael Owens for MXM

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

510(k) Number K103598