(204 days)
Not Found
No
The description focuses on patient-specific guides created from imaging data (MRI, CT) and manufactured using traditional methods. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The process described is based on direct anatomical mapping from imaging to guide design.
No
This device is identified as surgical instrumentation intended to assist in the positioning of total knee replacement components and guide bone marking, not to directly treat or prevent a disease or condition.
No
Explanation: The device is described as patient-specific surgical instrumentation intended to assist in the positioning of total knee replacement components and guiding bone marking, not for diagnosing a condition.
No
The device description explicitly states the guides are made from biocompatible nylon and stainless steel, indicating physical hardware components.
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 "intra-operatively" to assist in the positioning of total knee replacement components and guiding bone marking. This is a surgical aid used during a procedure on the patient's body.
- Device Description: The description reinforces this by stating the guides are "patient-specific guides created to fit the contours of the patient's distal femoral and tibial plateau anatomy" and are used as an "alternative to traditional alignment instrumentation used with Wright's ADVANCE® Total Knee System." This describes a surgical instrument.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing on biological samples.
The device is a surgical planning and guidance tool used directly on the patient during surgery, not a diagnostic test performed on a sample outside the body.
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® Total Knee System and its 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® Total Knee System, and thereby reduce the overall number of surgical steps required during total knee arthroplasty. The guides serve to position and align the ADVANCE® implants in a comparable position to traditional ADVANCE® instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, CT
Anatomical Site
Knee joint (distal femoral and tibial plateau anatomy)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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 .
- Biocompatibility testing .
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.
ADVANCE® Total Knee System (K061223, K972626)
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
K093405 (1 of 2)
Create Motion."
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
MAY 2 5 2010
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® Pre-Operative Navigation Alignment Guides.
| Submitted By: | Wright Medical Technology, Inc.
5677 Airline Rd.
Arlington, TN 38002 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 21, 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 | ADVANCE® Total Knee System
(K061223, K972626) |
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 905.826.1600 Canada 011.33.1.45.13.24.40 France 011.49.211.862.9990 Germany 011.39.0250.678.227 Italy 011.81.3.3538.0474 Japan 011.44.1483.721.404 UK
1
K093405(2 of 2)
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® Total Knee System, and thereby reduce the overall number of surgical steps required during total knee arthroplasty. The guides serve to position and align the ADVANCE® implants in a comparable position to traditional ADVANCE® instruments.
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® Total Knee System and its 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
011.39.0250.678.227 It
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 .
- Biocompatibility testing .
D. SUBSTANTIAL EQUIVALENCE INFORMATION
011 81 3 3538 0474 Japa
The main differences between the subject and predicate devices are in the patient-specific The safety and efficacy of the PROPHECY® Pre-Operative design and materials. 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® design goal, a comparison with traditional surgical technique, user repeatability testing and cadaver testing to ensure repeatability of design algorithm execution, a battery of biocompatibility tests to address material safety, and evidence that the material is sterilizable and its performance is unchanged by the sterilization process.
headquarters Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone www.wmt.com international subsidianes 011.32.3.378.39.05 Belgis 011.33.1.45.13.24.40 France
011 44 1483 721 404 UK
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Ms. Sarah Holtgrewe Manager, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002
MAY 2 5 2010
Re: K093405
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: II Product Code: MBH, JWH, OOG Dated: May 14, 2010 Received: May 17, 2010
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. 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Sarah Holtgrewe
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 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/ucm11.5809.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,
for
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):
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® Total Knee System and its 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 Eva
1 of 1
Snatic for nxm
(Division Signer)
Division of Surgic and Restorative D
510(k) Number K093405