Arthrex Virtual Implant Positioning (VIP) System

K230904 · Arthrex, Inc. · QHE · Jun 22, 2023 · Orthopedic

Device Facts

• Record ID: K230904
• Device Name: Arthrex Virtual Implant Positioning (VIP) System
• Applicant: Arthrex, Inc.
• Product Code: QHE · Orthopedic
• Decision Date: Jun 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The VIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis desktop software by trained Arthrex technicians. The VIP Web Portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis preoperative plan. It is indicated for use with the following implant lines: Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid), Univers Revers™ modular glenoid system (MGS) baseplates, and Arthrex humeral implants compatible with these implant lines. The OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning of glenoid and humeral components in total shoulder replacement, and intraoperative placement of the glenoid component in total shoulder replacement. The VIP Glenoid Targeter is indicated for use with the Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates. The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates. The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.

Device Story

System comprises web-based portal and desktop software (OrthoVis) for preoperative planning of total shoulder arthroplasty. Input: CT scan images uploaded to portal. Process: Arthrex technicians use OrthoVis to generate preoperative plans; surgeon reviews, modifies, and approves plan via portal. Output: Approved surgical plan for glenoid/humeral component placement. Used in clinical setting by surgeons; technicians perform initial planning. Facilitates accurate component positioning and intraoperative guidance via targeters/reamers. Benefits: Improved surgical planning accuracy and implant alignment.

Clinical Evidence

No clinical data. Bench testing only. Software verification and validation performed per FDA guidance, including unit, integration, and regression testing. Classified as major level of concern.

Technological Characteristics

Software-based preoperative planning system. Features automated image segmentation with manual verification. Web-based portal for image transfer/plan review; desktop application for plan generation. No hardware components described in this software-only submission.

Indications for Use

Indicated for patients undergoing total shoulder replacement requiring preoperative planning of glenoid and humeral components. Compatible with Univers Apex, Univers VaultLock, Univers Revers baseplate, and Univers Revers MGS systems.

Regulatory Classification

Identification

A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,” (vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Arthrex Virtual Implant Positioning (VIP) System software (K222007)
• Blue Ortho ExactechGPS Total Shoulder Application/Equinoxe Planning Software (K213546)

Submission Summary (Full Text)

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June 22, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.

Arthrex Inc. Troy Brooks Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K230904

Trade/Device Name: Arthrex Virtual Implant Positioning (VIP) System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHE Dated: April 19, 2023 Received: April 21, 2023

Dear Troy Brooks:

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 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

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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.

Farzana Sharmin -S

Farzana Sharmin, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty 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) K230904

Device Name

Arthrex Virtual Implant Positioning (VIP) System - VIP Web Portal

#### Indications for Use (Describe)

The VIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the Ortho Vis desktop software by trained Arthrex technicians.

The VIP Web Portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis preoperative plan. It is indicated for use with the following implant lines: Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid), Univers Revers™ modular glenoid system (MGS) baseplates, and Arthrex humeral implants compatible with these implant lines.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# Indications for Use

510(k) Number (if known) K230904

#### Device Name

Arthrex Virtual Implant Positioning (VIP) System - OrthoVis Preoperative Plan

#### Indications for Use (Describe)

The Ortho Vis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning of glenoid and humeral components in total shoulder replacement, and intraoperative placement of the glenoid component in total shoulder replacement.

The VIP Glenoid Targeter is indicated for use with the Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.

The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.

The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.

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

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

# 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."

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# 510(k) Summary

| Date Prepared | June 21, 2023 |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Troy Brooks, RAC<br>Manager, Regulatory Affairs<br>1-239-643-5553<br>[e-mail] |
| Name of Device | Arthrex Virtual Implant Positioning (VIP) System |
| Common Name | Preoperative Planning Software |
| Product Code | QHE |
| Classification Name | 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class | II |
| Primary Predicate | K222007: Arthrex Virtual Implant Positioning (VIP) System software (VIP Web Portal and OrthoVis Preoperative Plan) |
| Additional Predicate | K213546: Blue Ortho ExactechGPS Total Shoulder Application/Equinoxe Planning Software |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for new preoperative<br>planning of humeral components in total shoulder arthroplasty and associated expanded indications<br>for use for the existing Arthrex Virtual Implant Positioning (VIP) System software (VIP Web Portal and<br>OrthoVis Preoperative Plan) cleared under K222007. |
| Device Description | Arthrex Virtual Implant Positioning (VIP) System software comprises VIP Web Portal software and<br>OrthoVis Preoperative Plan software. The VIP Web Portal is web-based software intended for use to<br>facilitate the upload of medical images, preoperative planning, and plan approval of placement and<br>orientation of total joint replacement components. Each surgeon user's uploaded images are grouped<br>into cases and associated with that user's profile. Uploaded images can be downloaded from the VIP<br>Web Portal by Arthrex technicians and used to create preoperative plans in OrthoVis (a desktop<br>application). Once created, the preoperative plans are uploaded back to the VIP Web Portal, where the<br>surgeon user is then able to login and review the preoperative plan. Subsequently, the surgeon user<br>may either approve the plan, or modify the type, size, location and/or orientation of the joint<br>replacement component and then approve the plan. The approved plan is then made available for<br>download by the surgeon user. |
| Indications for Use | The VIP Web Portal is intended for use as a software interface and for the transfer of imaging<br>information from a medical scanner such as a CT scanner. It is also intended as software for<br>displaying/editing implant placement and surgical treatment options that were generated in the<br>OrthoVis desktop software by trained Arthrex technicians.<br><br>The VIP Web Portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis<br>preoperative plan. It is indicated for use with the following implant lines: UniversTM II and UniversTM<br>Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid<br>component, as well as the Univers ReversTM baseplate component (Universal Glenoid), Univers ReversTM<br>modular glenoid system (MGS) baseplates, and Arthrex humeral implants compatible with these<br>implant lines.<br><br>The OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates<br>accurate preoperative planning of glenoid and humeral components in total shoulder replacement, and<br>intraoperative placement of the glenoid component in total shoulder replacement.<br><br>The VIP Glenoid Targeter is indicated for use with the UniversTM II and UniversTM Apex total shoulder<br>systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as<br>the Univers ReversTM baseplate component (Universal Glenoid) and Univers ReversTM modular glenoid<br>system (MGS) baseplates. |
| | |
| Indications for Use<br>(continued) | The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the<br>Univers Revers™ modular glenoid system (MGS) baseplates.<br><br>The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is<br>intended to be used are the same as those described in the labeling for these shoulder systems. |
| Summary of<br>Technological<br>Characteristics | As compared to the primary predicate device used for preoperative planning of glenoid components,<br>the subject device now includes preoperative planning of both glenoid components and humeral<br>components.<br><br>Both the subject device and the additional predicate device include preoperative planning of glenoid<br>components and humeral components. The primary differences between subject device and the<br>additional predicate are minor visual and layout differences in the user interface, and segmentation is<br>performed manually for the additional predicate, whereas segmentation is automated (but manually<br>verified) with the subject device. |
| Performance Data | Software verification and validation testing were conducted and documentation was provided as<br>recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket<br>Submissions for Software Contained in Medical Devices." The software was considered as a "major"<br>level of concern. Activities included software validation/verification, regression testing, unit testing,<br>code reviews and checks and integration testing. |
| Conclusion | Based on the intended use, fundamental scientific technology, and the data provided in this Traditional<br>510(k), Arthrex has determined that the Arthrex Virtual Implant Positioning (VIP) System software (VIP<br>Web Portal and OrthoVis Preoperative Plan) is substantially equivalent to the predicate device. |

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