NextAR Hip is intended to support the surgeon during Total Hip Arthroplasty (THA) procedures by providing navigational information during bone preparation and positioning of acetabular cup components in skeletally mature individuals during supine or lateral approaches.

NextAR Hip is indicated for use with Medacta hip prosthesis as described in the implants' instruction for use. NextAR Hip provides stereotaxic guidance in reference to a patient's rigid anatomy as registered in CT based or imageless workflows.

As an optional display, the smart glasses can be used auxiliary to the NextAR Hip to view the same information as presented by the NextAR Hip. NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

Device Description

The NextAR Hip Platform is a computer-assisted surgical navigation platform used to support the surgeon during implantation in hip replacement procedures providing information on bone preparation, instrument guidance, and implant positioning.

The NextAR Hip Platform consists of three components:

NextAR hardware (composed of NextAR Control Unit, NextAR Tracking System and NextAR Smart Glasses);
NextAR Hip Software; and
NextAR Hip stereotaxic instruments.

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 target. Tracking sensor attached to the pelvis and surgical instruments enable the surgeon to register the position and orientation of the patient's anatomy and instrumentation relative to preoperative data in real-time while performing the surgical procedure. The tracking system is provided sterile.

NextAR Hip Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - NextAR Hip Platform

Page 1

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

Doc ID # 04017.08.02

January 9, 2026

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

Re: K252847
Trade/Device Name: NextAR Hip Platform
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: SBF
Dated: December 12, 2025
Received: December 12, 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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K252847 - 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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K252847 - Christopher Lussier 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

Indications for Use

NextAR Hip Platform Page 1 of 1

Field	Content
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.	K252847
Please provide the device trade name(s).	NextAR Hip Platform

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable).

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Page 5

510(k) Summary - K252847

NextAR Hip Platform Medacta International SA
Traditional 510(k)

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, Senior Director, Quality and Regulatory, Medacta USA

Date Prepared: September 08, 2025
Date Revised: December 12, 2025

II. Device

Field	Content
Device Proprietary Name	NextAR Hip Platform
Common or Usual Name	Stereotaxic Instrument
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 predicate devices.

Primary Predicate device:

Mako Total Hip Application, K243751, Mako Surgical Corp.

Additional Predicate devices:

Intellijoint® Navigation System, K191507, Intellijoint Surgical Inc.
NextAR RSA Platform, K210153, Medacta International SA
NextAR™ Spine Platform, K210859, Medacta International SA
NextAR TKA Platform, K193559, Medacta International SA

Reference device:

NextAR™ Spine, K250477, Medacta International SA

K252847, Page 1 of 3.

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NextAR Hip Platform Medacta International SA
Traditional 510(k)

IV. Device Description

The NextAR Hip Platform consists of three components:

NextAR hardware (composed of NextAR Control Unit, NextAR Tracking System and NextAR Smart Glasses);
NextAR Hip Software; and
NextAR Hip stereotaxic instruments.

NextAR Hip Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor.

V. Indications for Use

VI. Comparison of Technological Characteristics

The subject NextAR Hip Platform and the predicate devices (K243751, K191507) are substantially equivalent with respect to the following characteristics:

Power source;
User interface;
Imaging modalities;
Surgical workflow; and
Registration and planning features.

The subject NextAR Hip Platform and the predicate devices (K243751, K191507) differ with respect to the following characteristics:

Tracking system;
Use of smart glasses; and
Surgical guidance features.

K252847, Page 2 of 3.

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NextAR Hip Platform Medacta International SA
Traditional 510(k)

Discussion

The subject and predicate (K243751, K191507) devices have different tracking technology (active vs. passive markers) as well as the availability of head mounted display/smart glasses does not introduce any new safety and effectiveness question since these features are the same of the reference device (K250477).

The additional surgical guidance features provided by the subject device with respect to the predicate devices (K243751, K191507) are substantially equivalent as demonstrated by software verification and validation as well as performance testing.

The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject device with respect to the predicate devices.

VII. Performance Data

Based on the risk analysis, testing activities were conducted to written protocols. The following verifications and validations are provided in support of the substantial equivalence determination:

Non-Clinical Studies

Software verification and validation
Cadaver quantitative testing to demonstrate that the subject platform is equivalent to the conventional instrumentation as well as the subject instruments are adequate for their intended use
In vitro accuracy test to verify Leg Length and Lateral Offset assessment algorithms

Clinical Studies:

No clinical studies were conducted.

VIII. Conclusion

The information provided above supports that the subject device is substantially equivalent to the predicate devices.

K252847, Page 3 of 3.

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).