The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open/mini-open or percutaneous spine procedures. It is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include posterior approach spinal procedures, such as:

Pedicle Screw Placement (Thoracic and Lumbosacral spine)
Sacro-Iliac Screw Placement

NextAR Spine is also intended to provide planning tools for measuring and selecting the fixation rod for the thoracic and lumbosacral spine.

The NextAR Spine platform is intended to be used in combination with NextAR™ Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning, surgical planning software is used pre-operatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

NextAR Spine sterile drill and pins

The sterile drills, pins and iliac pins are part of the NextAR Spine platform which is intended as an aid for precisely locating anatomical structures in either open / mini open or percutaneous spine procedures. The NextAR Spine sterile drills pins and iliac pins are intended for use with the NextAR Spine platform according to its approved indications for use. All the drills are motorized. Pins may be used either motorized or manually. Iliac pins are manual.

Device Description

The NextAR™ Spine platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components:

Navigation software which displays information to the surgeon
Augmented Reality glasses
Optical tracking system
PC based hardware platform
Fiducial Block
Surgical instruments for spine surgery procedures

The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the instruments. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of the instrumentation relative to the intra-operative data in real-time while performing the surgical procedure. The tracking sensors, the fiducial block, and a group of pins and drills are provided sterile.

NextAR™ Spine aids the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor. The platform uses the information of either an intra-operative scan or pre-operative CT in combination with an intra-operative 3D scan in order to register the spine to navigation elements. The registration can be performed with one of the following approaches: 1) Direct 3D: based on the use of an intra-operative 3D scan, or 2) 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D scan.

Where the Direct 3D approach is utilized, NextAR™ Spine allows for planning of screw positioning on the patient's intraoperative DICOM images just before system setup. The application allows for navigating the spine with a screw planning superimposed on the acquired scan.

The NextAR™ Spine platform also includes the rod planning tool, which gives the surgeon information about the length and the rod type to best fit the spine anatomy and to perform the desired curvature correction.

The system's navigation technology is based on an active infrared camera coupled with an active tracker (Target). These elements allow, by means of the different registration approaches and use of compatible instruments, to accurately prepare trajectories in the vertebrae and/or to implant screws while visualizing information in real time on a screen monitor.

AI/ML Overview

The FDA 510(k) clearance letter for NextAR™ Spine (K250477) provides limited details on a comprehensive study proving acceptance criteria. However, based on the provided text, we can infer some aspects of the performance data and the methods used to demonstrate the device's substantial equivalence.

Here's an attempt to structure the information based on your request, highlighting what is explicitly stated and what can be inferred or is missing from this document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list acceptance criteria in a quantitative table format nor does it provide numerical performance metrics. Instead, it relies on comparative evaluations and qualitative assessments to demonstrate substantial equivalence to predicate devices. The "Performance Data" section primarily focuses on non-clinical studies.

Acceptance Criteria Category	Acceptance Criteria (Inferred/Implicit)	Reported Device Performance
Software Functionality	Software operates as intended and displays information accurately.	"Software testing" was performed, indicating the software functions were verified.
Instrument Equivalence	New instruments perform equivalently to previously cleared instruments.	"Comparative evaluations to demonstrate that the subject instruments are substantially equivalent to the predicate instruments used with NextAR Spine and cleared within K210859."
Surgical Suitability (Cadaver)	Instruments and system are adequate for intended surgical use.	"Cadaver workshops to demonstrate that the subject instruments are adequate for their intended use."
Tracking System Accuracy	The optical tracking system and fiducial registration maintain accuracy.	Stated as a shared characteristic with the predicate: "tracking system accuracy" and "fiducial registration accuracy" are maintained. No specific numerical thresholds or achieved performance reported in this document.
Biocompatibility	New instruments are biocompatible.	"The biocompatibility evaluation of the subject instruments leveraged identical materials and manufacturing to previously cleared instruments (K210859 and K200391)."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in terms of number of cases or subjects. "Cadaver workshops" imply surgical procedures performed on anatomical models (cadavers), but the number is not provided.
Data Provenance: The document does not specify the country of origin for the cadaver studies or the software testing. The studies were non-clinical. The studies were likely prospective in nature, as they were "performed in support of a substantial equivalence determination."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. However, the mention of "Cadaver workshops" suggests that surgeons or other qualified medical professionals would have been involved to assess the adequacy of the instruments and system for surgical use.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. Given that these were "cadaver workshops" to demonstrate adequacy, it's likely qualitative assessments by the participating surgeons, rather than a formal, multi-reader quantitative adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. The document explicitly states: "No clinical studies were conducted." This indicates that no MRMC study comparing human readers with and without AI assistance was performed. The device, NextAR™ Spine, is a surgical navigation platform, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies for reader performance improvement (e.g., radiologists interpreting images).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Not explicitly detailed with performance metrics. The "Software testing" and "Comparative evaluations" could be considered forms of standalone assessment of the algorithmic components and instrument performance, but no specific quantitative standalone performance (e.g., accuracy, precision) of the navigation algorithms themselves is provided in this summary. The device's primary function is as a navigation aid where a human surgeon is always in the loop.

7. Type of Ground Truth Used

Type of Ground Truth:
- For instrument performance, the ground truth would likely be established through engineering specifications and comparative measurements against predicate instruments.
- For the cadaver workshops, the ground truth was likely surgical outcomes/adequacy as determined by the participating surgeons in a realistic (cadaveric) surgical environment. This is a form of expert assessment of functional performance. It is not pathology, or clinical outcomes data, as no clinical studies were performed.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The document describes a traditional medical device (navigation system) with software components, not an AI/Machine Learning device that undergoes a train-test split methodology with large datasets for model training. The software functionality and instrument performance are verified through testing and comparative evaluation, not
ML model training on patient data.

9. How Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as this is not an AI/ML system requiring a dedicated training set with established ground truth in the typical sense for image interpretation or diagnosis. The "ground truth" for the device's functionality would stem from its design specifications, engineering principles, and the known anatomical relationships it aims to navigate.

In summary, the FDA 510(k) summary for NextAR™ Spine focuses on demonstrating substantial equivalence through non-clinical performance data, primarily through comparative evaluations with predicate devices and cadaveric workshops, rather than extensive clinical studies or AI model performance metrics.

Summary

FDA 510(k) Clearance Letter - NextAR™ Spine

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 31, 2025

Medacta International S.A.
℅ Christopher Lussier
Senior Director, Quality and Regulatory
Medacta USA
6386 Global Drive, Suite 101
Memphis, Tennessee 38141

Re: K250477
Trade/Device Name: NextAR™ Spine
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: SBF
Dated: February 19, 2025
Received: June 30, 2025

Dear Christopher Lussier:

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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K250477 - Christopher Lussier
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 systems (QS) regulation (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-

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K250477 - Christopher Lussier
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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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K250477

Device Name
NextAR™ Spine

Indications for Use (Describe)

NextAR Spine platform

Pedicle Screw Placement (Thoracic and Lumbosacral spine)
Sacro-Iliac Screw Placement

NextAR Spine is also intended to provide planning tools for measuring and selecting the fixation rod for the thoracic and lumbosacral spine.

NextAR Spine sterile drill and pins

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.

Page 5

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K250477

Device Name
NextAR™ Spine

Indications for Use (Describe)

NextAR Spine platform

Pedicle Screw Placement (Thoracic and Lumbosacral spine)
Sacro-Iliac Screw Placement

NextAR Spine is also intended to provide planning tools for measuring and selecting the fixation rod for the thoracic and lumbosacral spine.

NextAR Spine sterile drill and pins

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."

Page 6

K250477 - 510(k) Summary

Page 1 of 4

I. Submitter

Medacta International SA
Strada Regina
6874 Castel San Pietro (CH)
Switzerland
Phone (+41) 91 696 60 60
Fax (+41) 91 696 60 66

Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA
Applicant Correspondent: Chris Lussier, Director of Quality and Regulatory, Medacta USA

Date Prepared: February 19, 2025
Date Revised: July 33, 2025

II. Device

Device Proprietary Name:	NextAR™ Spine
Common or Usual Name:	Navigation System Total Joint Replacement
Classification Name:	Orthopedic Augmented Reality
Primary Product Code:	SBF
Regulation Number:	21 CFR 882.4560
Device Classification:	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary predicate device

NextAR™ Spine Platform K233172, Medacta International SA

Additional predicate device

NextAR™ Spine Platform K210859, Medacta International SA

IV. Device Description

The NextAR™ Spine platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components:

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K250477
Page 2 of 4

Navigation software which displays information to the surgeon
Augmented Reality glasses
Optical tracking system
PC based hardware platform
Fiducial Block
Surgical instruments for spine surgery procedures

V. Indications for Use

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K250477
Page 3 of 4

NextAR Spine platform

Pedicle Screw Placement (Thoracic and Lumbosacral spine)
Sacro-Iliac Screw Placement

NextAR Spine is also intended to provide planning tools for measuring and selecting the fixation rod for the thoracic and lumbosacral spine.

NextAR Spine sterile drill and pins

VI. Comparison of Technological Characteristics

The subject and predicate device (K233172) share the following characteristics:

principle of operation
user interface
power source
optical tracking system
platform
displaying technology
glasses communication
use of surgical instruments for navigation
main system components
use of surgical instruments for navigation

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K250477
Page 4 of 4

tracking system accuracy
use of active optical tracking system
computer hardware
pre-operative patient anatomy data acquisition
intra-operative patient anatomy data acquisition
use of surgical instruments for navigation
rod planning and intra operative screw planning features
fiducial registration accuracy
instruments' materials and sterility.

The biocompatibility evaluation of the subject instruments leveraged identical materials and manufacturing to previously cleared instruments (K210859 and K200391).

The main difference between the subject and predicate device (K233172) is the possibility to navigate new instruments and use new target mountings. The new instruments to be used in conjunction with the navigation platform, are substantially equivalent to the instruments already cleared within the additional predicate device (K210859).

VII. Performance Data

Non-Clinical Studies:

The following verification and validation activities have been performed in support of a substantial equivalence determination:

Software testing
Comparative evaluations to demonstrate that the subject instruments are substantially equivalent to the predicate instruments used with NextAR Spine and cleared within K210859
Cadaver workshops to demonstrate that the subject instruments are adequate for their intended use

Clinical Studies:

No clinical studies were conducted.

VIII. Conclusion

The information provided above supports that the NextAR™ Spine is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).