PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES

K103598 · Wrightmedicaltechnologyinc · MBH · Oct 17, 2011 · Orthopedic

Device Facts

Record IDK103598
Device NamePROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
ApplicantWrightmedicaltechnologyinc
Product CodeMBH · Orthopedic
Decision DateOct 17, 2011
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3565
Device ClassClass 2

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 Story

Patient-specific surgical guides; created from patient MRI/CT imaging data; designed to fit distal femoral and tibial plateau anatomy. Used intra-operatively by surgeons to assist in positioning total knee replacement components and marking bone for resection. Replaces traditional alignment instrumentation; reduces surgical steps. Guides manufactured from biocompatible nylon with stainless steel resection slots. Single-use device. Benefits include improved alignment accuracy and procedural efficiency for total knee arthroplasty.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including cadaver testing by end users to analyze placement location and orientation, and repeatability testing performed by design engineers.

Technological Characteristics

Patient-specific guides; materials: biocompatible nylon body with stainless steel resection slots. Single-use. Designed from patient MRI/CT imaging data. Provides mechanical alignment and resection guidance for total knee arthroplasty.

Indications for Use

Indicated for patients undergoing total knee arthroplasty requiring positioning of knee replacement components and bone marking; intended for use with Wright's ADVANCE® and EVOLUTION™ Total Knee Systems where anatomic landmarks are identifiable on imaging.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{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.<br>5677 Airline Rd.<br>Arlington, TN 38002 | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Date: | December 7, 2010 | | Contact Person: | Sarah Holtgrewe<br>Manager, Regulatory Affairs | | Proprietary Name: | PROPHECY® Pre-Operative Navigation<br>Alignment Guides | | Common Name: | Alignment and Resection Guides | | Classification Name and Reference: | 21 CFR 888.3565 --Knee joint patellofemorotibial<br>metal/polymer porous-coated uncemented<br>prosthesis--Class II | | | 21 CFR 888.3560 --Knee joint patellofemorotibial<br>polymer/metal/polymer/semi-constrained cemented<br>prosthesis--Class II | | Device Product Code and Panel Code: | Orthopedics/87/ MBH, JWH, OOG | | Predicate Device | PROPHECY® Pre-Operative Navigation<br>Alignment Guides<br>(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
Innolitics
510(k) Summary
Decision Summary
Classification Order
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