(311 days)
No
The description focuses on patient-specific guides created from CT data, serving as an alternative to traditional instrumentation. There is no mention of AI or ML in the device description, intended use, or performance studies. The process appears to be based on direct anatomical mapping from imaging data to guide design.
No.
The device is a surgical alignment guide, not an implant or treatment device, therefore it is not a therapeutic device.
No
This device is a surgical guide used to assist in the positioning of total ankle replacement components intra-operatively, not to diagnose a medical condition.
No
The device description explicitly states the guides are "designed and manufactured from patient imaging data (CT), and are made from biocompatible nylon." This indicates a physical, manufactured component, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Wright's PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are surgical instruments used intra-operatively to assist in the positioning of total ankle replacement components and guide bone marking. They are patient-specific guides based on imaging data, designed to fit the patient's anatomy.
- Lack of Biological Sample Testing: The device does not involve testing any biological samples from the patient. Its function is purely mechanical and related to surgical guidance based on anatomical structure.
Therefore, the device falls under the category of surgical instrumentation rather than in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
HSN, OYK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
distal tibial and proximal talar anatomy (for total ankle replacement components)
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® 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 ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
INBONE® Total Ankle Replacement (K051023)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.
0
DEC 1 6 2011
K110360 '1/2
Create Motion.
Image /page/0/Picture/3 description: The image shows the word "WRIGHT." in bold, sans-serif font. Below the word is a stylized graphic that resembles a "W" shape, created with thick, black lines. The overall impression is of a logo or branding element, with a clean and modern design.
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.
5677 Airline Rd.
Arlington, TN 38002 |
|-------------------------------------|-----------------------------------------------------------------------------------------------|
| Date: | December 12, 2011 |
| Contact Person: | Sarah Holtgrewe
Manager, Regulatory Affairs
(901) 867-4476 |
| Proprietary Name: | PROPHECY® INBONE® Pre-Operative
Navigation Alignment Guides |
| Common Name: | Alignment Guides |
| Classification Name and Reference: | 21 CFR 888.3110--Ankle joint metal/polymer semi-
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
| 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 | ||||
| 011.44.1483.721.404 UK | 011.49.211.862.9990 Germany |
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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.
- 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 (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
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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