(93 days)
Spine Guidance 5.4 Software Indications for Use:
The Q Guidance System, when used with the Spine Guidance 5 Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients.
The system is indicated for orthopedic and neurological spine procedures in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative stereotaxic guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified.
The system assists in the positioning of instruments for surgical procedures on the spine and pelvis, including:
- Screw and Needle Placement in the spine or pelvis
- Bone resection in the spine
- Interbody device placement in the lumbar spine (adults only)
Elite Q Attachments and Cutting Accessories:
The Elite Q Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE™) 2 Console and the Pi Drive 2 Motor or the Pi Drive 2 Plus Motor.
The Elite Q Attachments, when used with a compatible motor and a stereotactic instrument tracker, are also indicated as an accessory to the Stryker Spine Guidance Software.
Specific applications include but are not limited to minimally invasive spine (MIS) Spine applications, such as foraminotomy, facetectomy; orthopedic and neurological spine applications, such as corpectomy, pedicle subtraction osteotomy; and laminotomy / laminectomy.
Maestro Air Motor:
The Stryker Consolidated Operating Room Equipment (CORE™) Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
The Maestro Air Motor, when used with a compatible Elite Q Attachment and a stereotactic instrument tracker, is also indicated as an accessory to the Stryker Spine Guidance Software.
The Spine Guidance 5.4 System is an image guided stereotaxic, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning manual and powered instruments and locating patient anatomy during spinal surgery.
The system is comprised of the Spine Guidance 5.4 Software, the Q Guidance System (computer platform), Mako Spine System, navigated accessories / instruments (e.g., powered drills, pointers), and various system components (e.g., calibration devices, navigation adapters, patient / instrument trackers, etc.). The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies.
The computer platform consists of a computer, camera, big touchscreen monitor, and a small touchscreen monitor. The Spine Guidance 5.4 Software functionality is described in terms of its capabilities that feature planning, registration, and navigation of medical devices.
The Spine Guidance 5.4 Software includes all the existing features from the Spine Guidance 5.3 Software described in K252871. Updates to the software include the integration of the Q Drill Tracker as a new system component, ability to navigate the Maestro Air Motor, integration of additional burs, and now allows the NavLock Adapter to be used with two additional trackers.
The Maestro Air Motor is intended to be used with a compatible attachment and cutting accessory for cutting, drilling, reaming, decorticating, shaping, and smoothing of bone and bone cement in a variety of surgical procedures. The motor is usable in placement or cutting of screws, metals, wires, pins, and other fixation devices. The motor can also be navigated when performing computer assisted surgery using Spine Guidance 5.4 Software.
The Elite Q Attachments serve as the interface between a compatible motor and a distally attached cutting accessory. The Elite Q Attachments provide a location for mounting a stereotactic instrument tracker and support navigation of a high-speed drill as well as the system's instrument tip proximity detection feature.
The Elite Cutting Accessories are used for cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement in a variety of surgical procedures. The cutting accessories can also be used in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The cutting accessories support navigation of a high-speed drill as well as the system's instrument tip proximity detection feature.
N/A
FDA 510(k) Clearance Letter - K253623
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.03
February 19, 2026
Stryker Leibinger GmbH & Co KG
Andrea Wallen-Gerding
Principal Regulatory Affairs Specialist
Bötzinger Straße 41
Freiburg Im Breisgau, D-79111
Germany
Re: K253623
Trade/Device Name: Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attachments; Elite Cutting Accessories; Maestro Air Motor
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: November 18, 2025
Received: November 18, 2025
Dear Andrea Wallen-Gerding:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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K253623 - Andrea Wallen-Gerding Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K253623 - Andrea Wallen-Gerding Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
Shumaya Ali, M.P.H.
Assistant Director
DHT6C: Division of Restorative,
Repair, and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Page 1 of 1.
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253623
Please provide the device trade name(s).
Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attachments; Elite Cutting Accessories; Maestro Air Motor.
Please provide your Indications for Use below.
Spine Guidance 5.4 Software Indications for Use:
The Q Guidance System, when used with the Spine Guidance 5 Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients.
The system is indicated for orthopedic and neurological spine procedures in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative stereotaxic guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified.
The system assists in the positioning of instruments for surgical procedures on the spine and pelvis, including:
- Screw and Needle Placement in the spine or pelvis
- Bone resection in the spine
- Interbody device placement in the lumbar spine (adults only)
Elite Q Attachments and Cutting Accessories:
The Elite Q Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE™) 2 Console and the Pi Drive 2 Motor or the Pi Drive 2 Plus Motor.
The Elite Q Attachments, when used with a compatible motor and a stereotactic instrument tracker, are also indicated as an accessory to the Stryker Spine Guidance Software.
Specific applications include but are not limited to minimally invasive spine (MIS) Spine applications, such as foraminotomy, facetectomy; orthopedic and neurological spine applications, such as corpectomy, pedicle subtraction osteotomy; and laminotomy / laminectomy.
Maestro Air Motor:
The Stryker Consolidated Operating Room Equipment (CORE™) Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
The Maestro Air Motor, when used with a compatible Elite Q Attachment and a stereotactic instrument tracker, is also indicated as an accessory to the Stryker Spine Guidance Software.
Please select the types of uses (select one or both, as applicable). | ☒ Prescription Use (21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
Page 1 of 1.
Page 5
Stryker Leibinger GmbH & Co. KG. Section 6 – 510(k) Summary
Traditional 510(k) Page 1 of 7
6.0 Submitter Information
6.1 This Premarket Notification is submitted by:
Stryker Leibinger GmbH & Co. KG
Bötzinger Straße 41
79111 Freiburg, Germany
6.2 Contact Information
Primary Contact: Andrea N. Wallen-Gerding
Principal Regulatory Affairs Specialist
Telephone: (269) 491-9234
Email: andrea.wallengerding@stryker.com
Date Prepared: September 9, 2025
Alternate Contact: Mariah Knight
Principal Regulatory Affairs Specialist
Telephone: 971-294-0565
Email: mariah.knight@stryker.com
6.3 Device Name
Table 6-1: Device Name
| Subject (Modified) Device Information | |
|---|---|
| Trade/ Proprietary Name | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attachments; Elite Cutting Accessories; Maestro Air Motor |
| Common Name | Stereotaxic Instruments |
| Classification | Class II |
| Classification Product Code | OLO |
| Classification Name | Orthopedic Stereotaxic Instrument |
| Classification Regulation | 21 CFR 882.4560 |
| Review Panel | Orthopedic |
Page 6
K253623
Stryker Leibinger GmbH & Co. KG. Section 6 – 510(k) Summary
6.4 Predicate Devices
The following are the legally marketed predicate devices for the subject device included in this Traditional 510(k):
Table 6-2: Predicate Device List
| Subject Device | Predicate Device | Predicate Device 510(k) | Predicate Device Product Code | Manufacturer |
|---|---|---|---|---|
| Spine Guidance 5.4 Software | Spine Guidance 5.3 Software | K252871 | OLO | Stryker Leibinger GmbH & Co. KG |
| Maestro Air Motor | Maestro Air Motor | K150801 | HBB | Stryker Instruments |
| Elite Q Attachments | Elite Q Attachments | K252871 | OLO | Stryker Instruments |
| Elite Cutting Accessories | Elite Cutting Accessories | K252871 | OLO | Stryker Instruments |
6.5 Device Description
6.5.1 Spine Guidance 5.4 Software
The Spine Guidance 5.4 System is an image guided stereotaxic, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning manual and powered instruments and locating patient anatomy during spinal surgery.
The system is comprised of the Spine Guidance 5.4 Software, the Q Guidance System (computer platform), Mako Spine System, navigated accessories / instruments (e.g., powered drills, pointers), and various system components (e.g., calibration devices, navigation adapters, patient / instrument trackers, etc.). The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies.
The computer platform consists of a computer, camera, big touchscreen monitor, and a small touchscreen monitor. The Spine Guidance 5.4 Software functionality is described in terms of its capabilities that feature planning, registration, and navigation of medical devices.
The Spine Guidance 5.4 Software includes all the existing features from the Spine Guidance 5.3 Software described in K252871. Updates to the software include the integration of the Q Drill Tracker as a new system component, ability to navigate the Maestro Air Motor, integration of additional burs, and now allows the NavLock Adapter to be used with two additional trackers.
6.5.2 Maestro Air Motor
The Maestro Air Motor is intended to be used with a compatible attachment and cutting accessory for cutting, drilling, reaming, decorticating, shaping, and smoothing of bone and bone cement in a variety of surgical procedures. The motor is usable in placement or cutting of screws, metals, wires, pins, and other fixation devices. The motor can also be navigated when performing computer assisted surgery using Spine Guidance 5.4 Software.
Page 7
Stryker Leibinger GmbH & Co. KG. Section 6 – 510(k) Summary
Traditional 510(k) K253623, Page 2 of 7.
6.5.3 Elite Q Attachments
The Elite Q Attachments serve as the interface between a compatible motor and a distally attached cutting accessory. The Elite Q Attachments provide a location for mounting a stereotactic instrument tracker and support navigation of a high-speed drill as well as the system's instrument tip proximity detection feature.
6.5.4 Elite Cutting Accessories
The Elite Cutting Accessories are used for cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement in a variety of surgical procedures. The cutting accessories can also be used in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The cutting accessories support navigation of a high-speed drill as well as the system's instrument tip proximity detection feature.
6.6 Indications for Use
6.6.1 Spine Guidance 5.4 Software
The Q Guidance System, when used with the Spine Guidance 5 Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients.
The system is indicated for orthopedic and neurological spine procedures in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative stereotaxic guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified.
The system assists in the positioning of instruments for surgical procedures on the spine and pelvis, including:
- Screw and Needle Placement in the spine or pelvis
- Bone resection in the spine
- Interbody device placement in the lumbar spine (adults only)
6.6.2 Maestro Air Motor
The Stryker Consolidated Operating Room Equipment (CORE™) Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
The Maestro Air Motor, when used with a compatible Elite Q Attachment and a stereotactic instrument tracker, is also indicated as an accessory to the Stryker Spine Guidance Software.
6.6.3 Elite Q Attachments and Cutting Accessories
The Elite Q Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE™) 2 Console or CORE Maestro Air Pneumatic System and a compatible motor.
The Elite Q Attachments, when used with a compatible motor and a stereotactic instrument tracker, are also indicated as an accessory to the Stryker Spine Guidance Software.
K253623, Page 3 of 7.
Page 8
Stryker Leibinger GmbH & Co. KG. Section 6 – 510(k) Summary
Traditional 510(k)
Specific applications include but are not limited to minimally invasive spine (MIS) Spine applications, such as foraminotomy, facetectomy; orthopedic and neurological spine applications, such as corpectomy, pedicle subtraction osteotomy; and laminotomy / laminectomy.
6.7 Comparison of Technological Characteristics
A comparison of the technological characteristics of the subject devices included in the scope of this Traditional 510(k) is included in the tables below.
6.7.1 Technological Comparison between the Spine Guidance 5.4 Software and the Spine Guidance 5.3 Software
The technological comparison between the subject device (Spine Guidance 5.4 Software) and the predicate device (Spine Guidance 5.3 Software) is included in Table 6-3 below. The Spine Guidance 5.3 software application received 510(k) clearance per 510(k) number K252871.
Table 6-3: Technological Comparison between Spine Guidance 5.3 Software (Subject Device) and the Predicate Device
| Item | Subject Device: Spine Guidance 5.4 Software | Predicate Device: Spine Guidance 5.3 Software (K252871) |
|---|---|---|
| Indications for Use | The Q Guidance System, when used with the Spine Guidance 5 Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients.The system is indicated for orthopedic and neurological spine procedures in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative stereotaxic guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified.The system assists in the positioning of instruments for surgical procedures on the spine and pelvis, including:• Screw and Needle Placement in the spine or pelvis• Bone resection in the spine• Interbody device placement in the lumbar spine (adults only) | The Q Guidance System, when used with the Spine Guidance 5 Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients.The system is indicated for orthopedic and neurological spine procedures in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative stereotaxic guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified.The system assists in the positioning of instruments for surgical procedures on the spine and pelvis, including:• Screw and Needle Placement in the spine or pelvis• Bone resection in the spine• Interbody device placement in the lumbar spine (adults only) |
| Main System Components | • Q Guidance System• Mako Spine System• Various reusable and single use instruments for use with the SG5.4 Software | • Q Guidance System• Mako Spine System• Various reusable and single use instruments for use with the SG5.3 Software |
K253623, Page 4 of 7.
Page 9
Stryker Leibinger GmbH & Co. KG. Section 6 – 510(k) Summary
Traditional 510(k)
| Item | Subject Device: Spine Guidance 5.4 Software | Predicate Device: Spine Guidance 5.3 Software (K252871) |
|---|---|---|
| Modes of Operation | • Mako Robotic Arm pre-surgery check• Patient preparation• System set-up• Image import• Planning• Patient registration• Mako Robotic Arm setup• Navigation including trajectory guidance for screw placement | • Mako Robotic Arm pre-surgery check• Patient preparation• System set-up• Image import• Planning• Patient registration• Mako Robotic Arm setup• Navigation including trajectory guidance for screw placement |
| Operating Principle | • The software is installed on the computer that is part of the platform• Images are imported in DICOM format• The software displays the images and planned items with navigational information on a monitor | • The software is installed on the computer that is part of the platform• Images are imported in DICOM format• The software displays the images and planned items with navigational information on a monitor |
| Planning Navigation Features | • Screws (including Screw Placement Suggestion)• Measurements• Segmentations (Manual and automatic)• Local correlation (merge regions)• Planes• Smart Zones | • Screws (including Screw Placement Suggestion)• Measurements• Segmentations (Manual and automatic)• Local correlation (merge regions)• Planes• Smart Zones |
| Navigation implant Features | • Screw Placement• Interbody/Cage Placement | • Screw Placement• Interbody/Cage Placement |
| Localizing and Tracking Technology | Infrared Optical Active and Passive Tracking | Infrared Optical Active and Passive Tracking |
| System Accuracy | The system has a mean accuracy of 2 mm for positional displacement and 2° for trajectory angle displacement. Accuracy values apply to tracking in the workspace. | The system has a mean accuracy of 2 mm for positional displacement and 2° for trajectory angle displacement. Accuracy values apply to tracking in the workspace. |
| Supported Imaging Modalities | • Computed Tomography (CT)• Magnetic Resonance (MR)• Position emission tomography (PET)• 2D DICOM images (SCOUT only) | • Computed Tomography (CT)• Magnetic Resonance (MR)• Position emission tomography (PET)• 2D DICOM images (SCOUT only) |
| Intended Use Environment | Operating Room | Operating Room |
Traditional 510(k) K253623, Page 4 of 7.
Page 10
Stryker Leibinger GmbH & Co. KG. Section 6 – 510(k) Summary
Traditional 510(k)
6.7.2 Technological Comparison between the Maestro Air Motor and its Predicate Device
There have been no changes to the intended use, design, materials, or fundamental scientific technology between the subject and predicate devices. The only change is an update to the indications for use reflecting its use as an accessory with Spine Guidance 5.4 Software.
6.7.3 Technological Comparison between the subject and Predicate Elite Q Attachments
There have been no changes to the intended use, design, materials, or fundamental scientific technology between the subject and predicate devices. The only change is an update to their indications reflecting use with the CORE Maestro Air Pneumatic System.
6.7.4 Technological Comparison between the subject and Predicate Elite Cutting Accessories
There have been no changes to the intended use, design, materials, or fundamental scientific technology between the subject and predicate devices. The only change is an update to their indications reflecting use with the CORE Maestro Air Pneumatic System.
6.8 Summary of Non-Clinical Testing
The function and performance of the subject devices (Spine Guidance 5.4 Software, Maestro Air Motor, Elite Q Attachments, and Elite Cutting Accessories) have been evaluated through non-clinical design verification and validation testing. The results of the evaluation tests demonstrate that the subject devices successfully meet the requirements of their intended use, and the subject devices demonstrate substantial equivalence to the cited predicate devices.
Additional testing was performed on the subject devices to ensure they met their design requirements. A summary of the testing and the results are included in Table 6-3 below.
- Software testing as required by IEC 62304 and FDA Guidance on General Principles of Software Validation, January 11, 2002.
- System accuracy verification per ASTM F2554-22.
- The subject devices were validated with intended users in cadaver labs with simulated use tests to ensure the user needs and intended use requirements were met. All requirements were met and no new issues of safety or effectiveness were raised.
- Biocompatibility verification according to ISO 10993-1:2018 and the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, September 2023.
- Sterilization validation of the reusable devices was conducted according to ISO 17665-1 and the FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 2015).
- Sterilization validation of the single-use devices was conducted according to per ISO 11137-2 and the FDA Guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (January 2024).
- Electrical Safety and Electromagnetic Compatibility verification to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020.
6.9 Summary of Clinical Testing
No clinical testing was required to support this submission.
K253623, Page 6 of 7.
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Stryker Leibinger GmbH & Co. KG. Section 6 – 510(k) Summary
Traditional 510(k)
6.10 Conclusion
The subject devices, Spine Guidance 5.4 Software, Maestro Air Motor, Elite Q Attachments, and Elite Cutting Accessories perform as intended and are substantially equivalent to their respective predicate device with regard to intended use, indications for use, design, principles of operation, technology, materials, and performance. No new issues of safety or effectiveness have been raised. The performance testing supports a determination of substantial equivalence.
K253623, Page 7 of 7.
§ 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).