NextAR TKA Platform

K193559 · Medacta Inernational SA · SBF · Jul 10, 2020 · Neurology

Device Facts

• Record ID: K193559
• Device Name: NextAR TKA Platform
• Applicant: Medacta Inernational SA
• Product Code: SBF · Neurology
• Decision Date: Jul 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The NextAR™ TKA Platform is intended to be used to support the surgeon during total knee replacement procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning. The NextAR™ TKA Platform is intended to be used in combination with NextAR™ stereotaxic instruments, the MyKnee® NextAR™ cutting guides, and general surgical instruments to implant the GMK Sphere Total knee system and perform ligament balancing. As an optional display, the smart glasses can be used auxiliary to the NextAR Platform to view the same 2D stereotaxic information as presented by the NextAR Platform. The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display. The MyKnee® NextAR cutting guides include a camera/target holder and a PSI MyKnee® cutting guide both for tibia and femur. The MyKnee® cutting guides must be used as anatomical cutting blocks specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. MyKnee® NextAR TKA cutting guides are for single use only. The NextAR™ stereotaxic instruments are intended to be used to surgeon during specific orthopedic surgical procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning. The NextAR™ stereotaxic instruments, when registered with the myKnee NextAR TKA cutting guides, provide reference to a patient's rigid anatomical structures, such as the femur and tibia, that can be identified relative to pre-operative CT based planning.

Device Story

NextAR TKA Platform is a CT-based computer-assisted surgical navigation system for total knee replacement. Inputs include preoperative CT/MRI data and real-time spatial data from passive markers attached to patient bones, monitored by an infrared optical tracking system. The system processes these inputs to visualize bone, instrument, and implant orientation on a primary computer display; augmented reality glasses serve as an optional auxiliary 2D display. Used in the OR by surgeons, the system guides bone resection and implant placement via patient-specific MyKnee NextAR cutting blocks. The surgeon uses real-time visual feedback to execute the surgical plan, with the ability to adjust intraoperatively based on 3D models. The device aids in achieving accurate implant positioning and ligament balancing, potentially improving surgical outcomes.

Clinical Evidence

Evidence includes software validation, biocompatibility (ISO 10993-1), sterilization validation, shelf-life testing, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), mechanical/optical performance testing, and a cadaver study. No clinical trial data on human patients is reported.

Technological Characteristics

System components: PC-based hardware, infrared optical tracking, augmented reality glasses, and medical-grade nylon patient-specific cutting blocks. Operates via stereotaxic navigation using passive markers. Connectivity: Networked/integrated navigation platform. Sterilization: Gamma irradiation for single-use blocks; reusable instruments provided non-sterile. Software: Navigation and visualization algorithm.

Indications for Use

Indicated for patients undergoing total knee replacement procedures requiring bone resection, ligament balancing, and implant positioning using the GMK Sphere Total knee system.

Regulatory Classification

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.

Predicate Devices

• iMNS Medacta Navigation System (K083872, K100314)
• MyKnee Cutting Blocks (K093806)
• Xvision Spine System (K190929)

Submission Summary (Full Text)

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July 10, 2020

Medacta Inernational SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K193559

Trade/Device Name: NextAR TKA Platform Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, JWH, PBF Dated: July 10, 2020 Received: July 10, 2020

Dear Chris 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 (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 located 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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# Indications for Use

510(k) Number (if known) K193559

Device Name NextAR™ TKA Platform

### Indications for Use (Describe)

The NextAR™ TKA Platform is intended to be used to support the surgeon during total knee replacement procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning.

The NextAR™ TKA Platform is intended to be used in combination with NextARTM stereotaxic instruments, the MyKnee® NextAR™ cutting guides, and general surgical instruments to implant the GMK Sphere Total knee system and perform ligament balancing. As an optional display, the smart glasses can be used auxiliary to the NextAR Platform to view the same 2D stereotaxic information as presented by the NextAR Platform.

The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

The MyKnee® NextAR cutting guides include a camera/target holder and a PSI MyKnee® cutting guide both for tibia and femur. The MyKne® cutting guides must be used as anatomical cutting blocks specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. MyKnee® NextAR TKA cutting guides are for single use only.

The NextAR™ stereotaxic instruments are intended to be used to surgeon during specific orthopedic surgical procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning. The NextAR™ stereotaxic instruments, when registered with the myKnee NextAR TKA cutting guides, provide reference to a patient's rigid anatomical structures, such as the femur and tibia, that can be identified relative to pre-operative CT based planning.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# K193559

# 510(k) Summary

#### I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone [phone] Fax [phone]

Contact Person: Stefano Baj, Regulatory Affairs Manager, Medacta International SA Applicant Correspondent: Christopher Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: December 20, 2019 Date Revised: July 8, 2020

#### II. Device

| Device Proprietary Name: | NextART™ TKA Platform |
|--------------------------|------------------------------------------------------------|
| Common or Usual Name: | Navigation System |
| | Total Joint Replacement |
| Classification Name: | Stereotaxic Instrument |
| | Knee joint patellofemorotibial polymer/metal/polymer semi- |
| | constrained cemented prosthesis. |
| Primary Product Code: | OLO |
| Secondary Product Codes: | JWH |
| | PBF |
| Regulation Number: | 21 CFR 882.4560 |
| Device Classification | II |

#### III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary predicate device:

- iMNS Medacta Navigation System, K083872 and K100314, Medacta International SA ●
Additional predicate device:

- MyKnee Cutting Blocks, K093806, Medacta International SA ●
- . Xvision Spine System, K190929, Augmedics Ltd.

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#### IV. Device Description

The NextAR™ TKA Platform is a CT based computer-assisted surgical navigation platform used in total knee replacement surgery and includes the following components:

- navigation software which displays information to the surgeon in real-time;
- Augmented Reality glasses;
- optical tracking system; ●
- PC based hardware platform; ●
- MyKnee NextAR Cutting Blocks; and ●
- reusable surgical instruments for total knee replacement procedures. ●

The system operates on the common principle of stereotaxic technology in which passive markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the markers to avoid intraoperative registration of bony landmarks. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of bones and instrumentation relative to preoperative data in real-time while performing the surgical procedure. The tracking sensors are provided sterile.

The NextAR™ TKA Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor. The placement of the implants is performed by cutting the bones using MyKnee® NextAR™ Cutting Blocks while reusable surgical instrumentation (provided non-sterile) guided by the tracking sensors can be used for recut. Although the position of the implants can be validated to assess the correct execution of the planning, the surgeon can change the surgical plan intraoperatively by analyzing the 3D models of the patient, the CT scan, and the 3D geometry of the implants.

The MyKnee® NextAR™ Cutting Blocks, manufactured from medical grade nylon, are single use patient-specific blocks which are designed from patient MRI or CT images. The blocks are designed to be used in standard medial or lateral parapatellar surgical approaches with each set comprised of a femoral block, a tibial block, and two bone models of the patient's femur and tibia (optional). The femoral cutting blocks are provided in right and left configurations in sizes 1 to 7 and 1+ to 6+ and the tibial cutting blocks are provided in right and left configurations in sizes 1 to 6. The blocks are provided sterile via gamma irradiation or non-sterile.

#### V. Indications for Use

"The NextAR™ TKA Platform is intended to be used to support the surgeon during total knee replacement procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning.

The NextAR™ TKA Platform is intended to be used in combination with NextAR™ stereotaxic instruments, the MyKnee® NextAR™ cutting guides, and general surgical instruments to implant the GMK Sphere Total knee system and perform ligament balancing. As an optional display, the

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smart glasses can be used auxiliary to the NextAR Platform to view the same 2D stereotaxic information as presented by the NextAR Platform.

The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

The MyKnee® NextAR cutting guides include a camera/target holder and a PSI MyKnee® cutting guide both for tibia and femur. The MyKnee® cutting guides must be used as anatomical cutting blocks specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. MyKnee® NextAR TKA cutting guides are for single use only.

The NextARTM stereotaxic instruments are intended to be used to support the surgeon during specific orthopedic surgical procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning. The NextAR™ stereotaxic instruments, when registered with the myKnee NextAR TKA cutting guides, provide reference to a patient's rigid anatomical structures, such as the femur and tibia, that can be identified relative to pre-operative CT based planning."

#### VI. Comparison of Technological Characteristics

The NextAR™ TKA Platform and the predicate device (iMNS Medacta Navigation System) share the following characteristics:

- principle of operation; ●
- user interface;
- power source;
- surgical workflow; ●
- . main system components; except MyKnee NextAR Cutting Blocks;
- use of surgical instruments for navigation; ●
- . orientation and positioning of bone resections; and
- device accuracy. ●

The NextAR™ TKA Platform and the predicate device (iMNS Medacta Navigation System) are technologically different with respect to:

- use of active vs. passive optical tracking system; ●
- . registration of anatomy through patient specific instrumentation;
- computer hardware;
- use of MyKnee NextAR Cutting Blocks; and ●
- pre-operative vs. intraoperative data acquisition. ●

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The MyKnee® NextAR™ Cutting Blocks and the predicate device (MyKnee Cutting Blocks) share the following characteristics:

- material of construction; ●
- manufacturing process; ●
- . size and dimensions;
- sterilization method; and ●
- . packaging.

The MyKnee® NextAR™ Cutting Blocks and the predicate device (MyKnee Cutting Blocks) are technologically different with respect to the number of contact point positions.

## Discussion

There are minor differences between the subject and predicate devices; however, these differences do not raise different questions of safety or effectiveness when compared to the predicate device. Both navigation systems utilize stereotaxic technologies within the same surgical workflow. Minor differences in the optical tracking systems and use of patient specific instrumentation are addressed by performance testing.

#### VII. Performance Data

Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following studies were performed in support of a substantial equivalence determination:

- software validation;
- biocompatibility per ISO 10993-1:2009; ●
- . sterilization validation;
- . shelf-life testing;
- electrical safety testing per IEC 60601-1:2005, COR1:2006, COR2:2007, Amd1:2012;
- electromagnetic compatibility testing per IEC 60601-1-2:2014;
- performance testing to evaluate mechanical and optical properties; and
- cadaver study.

## VIII. Conclusion

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

Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations. The NextAR™ TKA Platform can be considered substantially equivalent to the identified predicate devices.