(91 days)
Not Found
No
The document describes a computer-assisted surgical navigation system that uses sensors and a computer module for positional information and calculations, but there is no mention of AI or ML technologies being used for these functions.
No
The device is a computer-assisted surgical navigation system that aids in determining anatomical alignment and positioning implants during orthopedic surgeries. It does not directly provide therapy but rather assists the surgeon in performing the procedure.
No
The device is a computer-assisted surgical navigation system designed to assist the surgeon in determining reference alignment axes and facilitating accurate implant positioning, rather than diagnosing a condition. It provides guidance during surgery, which is an interventional function, not a diagnostic one.
No
The device description explicitly states it utilizes a "palm-sized computer module and reference sensor" and the performance studies include "System hardware verification/validation testing". This indicates the device includes hardware components beyond just software.
Based on the provided information, the OrthAlign Plus® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- OrthAlign Plus® System Function: The OrthAlign Plus® System is a surgical navigation system used during orthopedic surgical procedures. It assists the surgeon in determining anatomical alignment and positioning implants. It does not analyze biological specimens.
The description clearly states its purpose is to assist the surgeon in vivo (within the living body) during surgery, not to perform tests on samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty.
Example orthopedic surgical procedures include but are not limited to:
- Total Knee Arthroplasty
- Total Hip Arthroplasty: Anterior/Posterior
- Unicompartmental Knee Arthroplasty: Tibial transverse resection
Product codes
OLO
Device Description
The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.
In knee arthroplasty procedures, the device assists the surgeon in:
- Establishing the mechanical axis of the femur. determining the varus/valgus and the flexion/extension angle of the cutting block relative to the femur.
- Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia.
In hip arthroplasty procedures, the device assists the surgeon in:
- Establishing the orientation of the anterior pelvic plane and determining the inclination angle and the anteversion angle of the shell impactor relative to the anterior pelvic plane, or to the anterior pelvic plane adjusted for pelvic tilt.
- Measuring the intraoperative change in leg length and offset.
In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:
- Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, Tibia, Pelvis, Hip, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, clinical staff
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
For simulated use testing, a prospective cadaver validation was done in a simulated operating room environment with a surgeon conducting the procedures.
Measurement of the intraoperative change in leg length and offset was validated for the anterior approach with 40 data points (on 5 hips), using radiographic evaluation of the leg length and offset changes.
Navigation of the acetabular shell insertion relative to the anterior pelvic plane adjusted for pelvic tilt was validated for the anterior approach with 38 data points (on 5 hips), using radiographic evaluation of the cup placement angles.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device performance testing confirms that the OrthAlign Plus® System can be used according to its intended use. The OrthAlign Plus® System has been verified and validated according to OrthAlign's procedures for product design and development. Performance testing addressed the new functionality and surgical procedure steps. Performance testing included:
- Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences.
- System hardware verification/validation testing to ensure the electronics hardware meets its mechanical requirements.
- Electrical safety testing to IEC 60601-1:2005 + Corr. 1 (2006) + Corr. 2 (2007) + AM1 (2012) or IEC 60601-1:2012.
- Electromagnetic compatibility testing to IEC 60601-1-2: 2015.
- Laser product safety verification to IEC 60825-1:2014.
- Instrumentation cleaning, sterilization and shipping validations for the specified processes.
- Navigation device sterilization, packaging, shelf life, environmental conditions and shipping validations for the specified ranges of conditions involved in each process. (Summary data for the identical predicate device is referenced for some validations.)
- System components biocompatibility assessment per ISO 10993-1 (2009).
- Customer requirements validation with an advising surgeon to validate the system meets design input requirements for its functions in a simulated use environment.
- System accuracy testing: bench testing with mechanical fixtures and foam models to verify leg length and offset and updated scale reader measurement accuracy.
- Simulated use testing in cadaver to validate system accuracy vs. the gold standard of radiographic measurement in a simulated use environment.
For simulated use testing, a prospective cadaver validation was done in a simulated operating room environment with a surgeon conducting the procedures.
Measurement of the intraoperative change in leg length and offset was validated for the anterior approach with 40 data points (on 5 hips), using radiographic evaluation of the leg length and offset changes.
Navigation of the acetabular shell insertion relative to the anterior pelvic plane adjusted for pelvic tilt was validated for the anterior approach with 38 data points (on 5 hips), using radiographic evaluation of the cup placement angles.
This testing regime demonstrates that the subject device is as safe, as effective, and performs as well as or better than the predicate devices. This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate devices, for its intended use in facilitating the accurate measurement of intraoperative change in leg length and offset and navigation of the acetabular shell impactor relative to the anterior pelvic plane adjusted for pelvic tilt, in THA, anterior approach.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OrthAlign Plus® System (K153237), Stryker Navigation System - CT Based Hip Module (K050615)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2017
Orthalign, Inc. David Vancelette Director OA/RA 120 Columbia, Suite 500 Aliso Viejo. California 92656
Re: K162962
Trade/Device Name: Orthalign Plus System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 21, 2016 Received: October 24, 2016
Dear David Vancelette:
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
| 510(k) Number (if known) | K162962 |
|---|---|
| -------------------------- | --------- |
Device Name OrthAlign Plus System
Indications for Use (Describe)
The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty.
Example orthopedic surgical procedures include but are not limited to:
- · Total Knee Arthroplasty
- · Total Hip Arthroplasty: Anterior/Posterior
- · Unicompartmental Knee Arthroplasty: Tibial transverse resection
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
3
5. 510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).
| DATE | October 21, 2016 |
|---|---|
| APPLICANT | OrthAlign, Inc. |
| 120 Columbia | |
| Suite 500 | |
| Aliso Viejo, CA 92656 | |
| Tel: (949) 715-2424 | |
| Fax: (949) 831-9500 | |
| OFFICIAL | |
| CORRESPONDENT | David Vancelette |
| OrthAlign, Inc. | |
| 120 Columbia, | |
| Suite 500 | |
| Aliso Viejo, CA 92656 | |
| dvancelette@orthalign.com | |
| Tel: (858) 692-0335 | |
| Fax: (949) 831-9500 | |
| TRADE NAME | OrthAlign Plus® System |
| COMMON NAME | Stereotaxic Instrument |
| DEVICE | |
| CLASSIFICATION | Class II, 21 CFR §882.4560 |
| PRODUCT CODES | OLO: Orthopedic Stereotaxic Instrument |
| PREDICATE | |
| DEVICES | OrthAlign Plus® System (K153237) |
| Stryker Navigation System - CT Based Hip Module | |
| (K050615) | |
| SUBMISSION TYPE | Traditional 510(k). The subject device is a modification |
| to the previously cleared OrthAlign Plus® System | |
| (K153237). |
SUBSTANTIALLY EQUIVALENT TO:
The OrthAlign Plus® System is substantially equivalent to the previously cleared OrthAlign Plus® System (K153237) and Stryker Navigation System – CT Based Hip Module (K050615).
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to
4
detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.
In knee arthroplasty procedures, the device assists the surgeon in:
- Establishing the mechanical axis of the femur. determining the varus/valgus and ● the flexion/extension angle of the cutting block relative to the femur.
- Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia.
In hip arthroplasty procedures, the device assists the surgeon in:
- . Establishing the orientation of the anterior pelvic plane and determining the inclination angle and the anteversion angle of the shell impactor relative to the anterior pelvic plane, or to the anterior pelvic plane adjusted for pelvic tilt.
- Measuring the intraoperative change in leg length and offset.
In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:
- Establishing the mechanical axis of the tibia, determining the varus/valgus angle and ● the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.
INDICATIONS FOR USE:
The OrthAlign Plus® System has the same indications for use as the previously cleared OrthAlign Plus System (K153237). Additional functionality has been added to the predicate device to enable the measurement of intraoperative change in leg length and offset and navigation of the shell impactor to an alternate reference plane in total hip arthroplasty: anterior approach. Also, Indications for Use are common to the Stryker Navigation System - CT Based Hip Module (K050615). Thus, the Indications for Use are as follows:
OrthAlign Plus® System:
The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty.
Example orthopedic surgical procedures include but are not limited to:
5
- Total Knee Arthroplasty
- . Total Hip Arthroplasty: Anterior/Posterior
- Unicompartmental Knee Arthroplasty: Tibial transverse resection ●
TECHNICAL CHARACTERISTICS (COMPARED TO PREDICATE):
The OrthAlign Plus® System was cleared under K153237. The OrthAlign Plus® System comprises a single use computer module, a reusable reference sensor, a reusable femoral jig, a reusable tibial jig, a reusable posterior hip jig and a reusable anterior hip jig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical and numerical representation of instruments and anatomy on the user display screen. The OrthAlign Plus System is being updated for total hip arthroplasty: anterior approach to include navigation of the shell impactor to an alternate reference plane, as in the predicate device Stryker Navigation System - CT Based Hip Module (K050615), and enable the measurement of intraoperative change in leg length and offset using a laser to guide repositioning of the leg, as in the predicate device OrthAlign Plus® System (K153237). All other features and principles of operation remain unchanged.
PERFORMANCE DATA:
Device performance testing confirms that the OrthAlign Plus® System can be used according to its intended use. The OrthAlign Plus® System has been verified and validated according to OrthAlign's procedures for product design and development. Performance testing addressed the new functionality and surgical procedure steps. Performance testing included:
- . Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences.
- System hardware verification/validation testing to ensure the electronics hardware meets its mechanical requirements.
- Electrical safety testing to IEC 60601-1:2005 + Corr. 1 (2006) + Corr. 2 (2007) + AM1 (2012) or IEC 60601-1:2012.
- Electromagnetic compatibility testing to IEC 60601-1-2: 2015.
- Laser product safety verification to IEC 60825-1:2014.
- Instrumentation cleaning, sterilization and shipping validations for the specified processes.
- Navigation device sterilization, packaging, shelf life, environmental conditions and shipping validations for the specified ranges of conditions involved in each process. (Summary data for the identical predicate device is referenced for some validations.)
- System components biocompatibility assessment per ISO 10993-1 (2009). ●
- Customer requirements validation with an advising surgeon to validate the system . meets design input requirements for its functions in a simulated use environment.
- System accuracy testing: bench testing with mechanical fixtures and foam models to
6
verify leg length and offset and updated scale reader measurement accuracy.
- . Simulated use testing in cadaver to validate system accuracy vs. the gold standard of radiographic measurement in a simulated use environment (see discussion below).
For simulated use testing, a prospective cadaver validation was done in a simulated operating room environment with a surgeon conducting the procedures.
Measurement of the intraoperative change in leg length and offset was validated for the anterior approach with 40 data points (on 5 hips), using radiographic evaluation of the leg length and offset changes.
Navigation of the acetabular shell insertion relative to the anterior pelvic plane adjusted for pelvic tilt was validated for the anterior approach with 38 data points (on 5 hips), using radiographic evaluation of the cup placement angles.
This testing regime demonstrates that the subject device is as safe, as effective, and performs as well as or better than the predicate devices. This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate devices, for its intended use in facilitating the accurate measurement of intraoperative change in leg length and offset and navigation of the acetabular shell impactor relative to the anterior pelvic plane adjusted for pelvic tilt, in THA, anterior approach.
The information provided by OrthAlign in this 510(k) application confirms that the OrthAlign Plus® System is substantially equivalent to predicate devices such as the OrthAlign Plus® System (K153237) and Stryker Navigation System - CT Based Hip Module (K050615).
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
A technological comparison and bench and cadaver testing demonstrate the substantial equivalence of the OrthAlign Plus® System to the predicate devices.
The subject device is identical to the predicate OrthAlign Plus® System (K153237), with the following exceptions:
- The subject device allows for the measurement of intraoperative changes in leg length and joint offset in THA, anterior approach.
- The subject device uses a laser to facilitate repositioning of the leg for the ● measurement of intraoperative changes in leg length and joint offset in THA, anterior approach.
- . The subject device allows for the navigation of the acetabular shell impactor relative to the anterior pelvic plane adjusted for pelvic tilt, in THA, anterior approach.
The table below summarizes the features of the subject device as compared to the predicate devices.
7
Table 1. OrthAlign Plus® System Components, Classes & Clearances – Summary
| Property | SUBJECT DEVICE
ORTHALIGN PLUS® SYSTEM | PREDICATE 1
ORTHALIGN PLUS® SYSTEM (K153237) | PREDICATE 2
Stryker Navigation System – CT
Based Hip Module (K050615) |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Total Knee Arthroplasty / Total Hip
Arthroplasty:
The OrthAlign Plus® System is a
computer-controlled system intended to
assist the surgeon in determining
reference alignment axes in relation to
anatomical and instrumentation structures
during stereotactic orthopedic surgical
procedures. The OrthAlign Plus®
System facilitates the accurate positioning
of implants, relative to these alignment
axes. The system aids the surgeon in
controlling leg length and offset
discrepancies in Total Hip Arthroplasty.
Example orthopedic surgical procedures
include but are not limited to:
Total Knee Arthroplasty Total Hip Arthroplasty:
Anterior/Posterior Unicompartmental Knee
Arthroplasty: Tibial transverse
resection | Total Knee Arthroplasty /Total Hip
Arthroplasty:
The OrthAlign Plus® System is a
computer-controlled system intended to
assist the surgeon in determining
reference alignment axes in relation to
anatomical and instrumentation structures
during stereotactic orthopedic surgical
procedures. The OrthAlign Plus®
System facilitates the accurate positioning
of implants, relative to these alignment
axes. The system aids the surgeon in
controlling leg length and offset
discrepancies in Total Hip Arthroplasty:
Posterior.
Example orthopedic surgical procedures
include but are not limited to:
Total Knee Arthroplasty Total Hip Arthroplasty:
Anterior/Posterior Unicompartmental Knee
Arthroplasty: Tibial transverse
resection | Total Hip Arthroplasty:
The Navitrack Stryker Navigation
System - CT Based Hip Module is
intended as a planning and
intraoperative guidance system to
enable open or percutaneous computer
assisted surgery. The system is
indicated for any medical condition in
which the use of computer assisted
surgery may be appropriate, and where a
reference to a rigid anatomical structure
such as but not limited to the pelvis, or
femur, can be identified.
The system shall be operated only by
trained personnel such as orthopedic
surgeons and clinical staff.
The Stryker Navigation System - Hip
Module supports, but is not limited to
the following surgical procedures Any form of Total Hip
Arthroplasty (THA), e.g. open or
minimally invasive Precisely position instruments,
implants and bony tissue during
orthopedic surgery, such as
operations performed with Hip
and bones in the upper extremities Revisions |
| Property | SUBJECT DEVICE
ORTHALIGN PLUS® SYSTEM | PREDICATE 1
ORTHALIGN PLUS® SYSTEM (K153237) | PREDICATE 2
Stryker Navigation System – CT
Based Hip Module (K050615) |
| Technological Principles | | | |
| Computer generation of
positional information | Uses inertial sensors, microcontroller and
digital signal processor to generate
positional information, based on physical
positions of registration instruments. | Identical | Similar. Uses stereoscopic camera,
reflective trackers and computer to
generate positional information, based
on physical positions of registration
instruments. |
| Registration of anatomy | Ipsilateral ASIS, contralateral ASIS and
pubic symphysis are registered to
establish a pelvic reference frame, which
can be rotated normal to the gravity
vector, to adjust for pelvic tilt. | Similar. Identical registrations and
anterior pelvic reference frame. | Similar. Optical registration of identical
indicated anatomic points. Computer
generation of identical anterior pelvic
reference frame. Similar adjustment for
pelvic tilt. |
| Navigation of acetabular
shell impactor | With anteversion and abduction angles | Identical | Identical |
| Measurement of
intraoperative changes in
leg length and offset | For total hip arthroplasty: posterior and
anterior approaches | Similar: for total hip arthroplasty:
posterior approach | Identical |
| Surgical work flow | ● Patient preparation
● Instrument setup
● Instrument attachment to patient
● Anatomic registrations
● Joint preparation
● Implant navigation
● Measurement of changes in leg
position | Identical | Identical |
| Design Elements | | | |
| Property | SUBJECT DEVICE
ORTHALIGN PLUS® SYSTEM | PREDICATE 1
ORTHALIGN PLUS® SYSTEM (K153237) | PREDICATE 2
Stryker Navigation System – CT
Based Hip Module (K050615) |
| Main System
Components | Single-use computer unit
Navigation software
Reusable instrument set
Registration instruments
Acetabular Shell Impactor | Identical | Similar: reusable computer console
instead of single-use unit. Other
elements identical. |
| ser Interface | Integrated graphical user interface, on
single-use unit that attached to
instrumentation. | Identical. | Similar: graphical user interface on
reusable console screen outside the
sterile field. |
| Femur registration | Physically registers a fiduciary point:
instrument attaches to the femur. | Similar: physically registers a fiduciary
plate: instrument temporarily attaches to
the femur. | Similar: optically registers a fiduciary
element: instrument attaches to the
femur. |
| Leg positioning | Laser crosshair pattern used to locate leg. | Similar: visual positioning and
registration of a reference plane used to
locate leg. | Similar: visual positioning and
registration of a reference plane used to
locate leg. |
8
9