Arthrex Virtual Implant Positioning (VIP) System

K222007 · Arthrex, Inc. · QHE · Mar 8, 2023 · Orthopedic

Device Facts

• Record ID: K222007
• Device Name: Arthrex Virtual Implant Positioning (VIP) System
• Applicant: Arthrex, Inc.
• Product Code: QHE · Orthopedic
• Decision Date: Mar 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2

Intended Use

The VIP Glenoid Targeter is a manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The VIP Glenoid Targeter is indicated for use with the Univers™ II and 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 intended for use with the VIP Glenoid Targeter in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. 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 VIP glenoid instrumentation is intended to be used are the same as those described in the labeling for these shoulder systems. The OrthoVis preoperative plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. 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 glenoid implant lines: Univers™ II and 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.

Device Story

System facilitates preoperative planning and intraoperative glenoid preparation for total shoulder arthroplasty. Inputs: CT scan imaging data. Process: Trained technicians use OrthoVis desktop software to generate surgical plans; surgeon reviews and approves plans via VIP Web Portal. Output: Preoperative surgical plan and physical instrumentation (VIP Glenoid Targeter and Reamers) for guide pin placement and glenoid reaming. Used in clinical settings by orthopedic surgeons. Reamers feature depth control mechanisms to ensure accuracy based on approved plans. Benefits: Improved accuracy of implant positioning and glenoid preparation; reduced risk of malpositioning.

Clinical Evidence

No clinical data. Evidence consists of bench testing (compression testing of depth control features, side-by-side accuracy testing of reaming depth) and cadaveric validation to confirm user needs, safety, and effectiveness.

Technological Characteristics

Stainless-steel reusable glenoid reamers; manual instrumentation; depth control features; software-based preoperative planning; cloud/web-based interface for plan review; sterilization via standard methods.

Indications for Use

Indicated for patients undergoing total shoulder replacement requiring glenoid component implantation. Compatible with Univers II, Univers Apex, Univers VaultLock, and Univers Revers MGS systems. Used for preoperative planning and intraoperative glenoid preparation via central guide pin and reaming.

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 Glenoid Intelligent Reusable Instrument System (K162697)
• Arthrex OrthoVis Preoperative Plan (K162697)
• SmartBase for Arthrex Glenoid Iris (K162697)
• Arthrex VIP Web Portal (K162697)
• Signature™ ONE System (K212560)

Reference Devices

• Arthrex VIP Web Portal (K193523)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 8, 2023

Arthrex Inc. Ivette Galmez Regulatory Affairs Prinicipal Specialist 1370 Creekside Boulevard Naples, Florida 34108

Re: K222007

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, KWS, PHX, LLZ Dated: February 9, 2023 Received: February 10, 2023

Dear Ivette Galmez:

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

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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 (OS) 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 mediation-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
Digitally signed by
Farzana Sharmin -S
Sharmin -S Date: 2023.03.08
12:24:11-05'00'

For Jiping Chen, MD, Ph.D., M.P.H. Division 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)

K222007

Device Name

Arthrex Virtual Implant Positioning (VIP) System - VIP Glenoid Instrumentation

#### Indications for Use (Describe)

The VIP Glenoid Targeter is a manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaulfLock® 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 intended for use with the VIP Glenoid Targeter in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the 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 VIP glenoid instrumentation 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) |
|-------------------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# Indications for Use

510(k) Number (if known)

K22007

Device Name

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

#### Indications for Use (Describe)

The OrthoVis preoperative plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning 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"> <b> </b> </span> <span style="font-family:Arial, sans-serif"> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px"> <b> </b> </span> <span style="font-family:Arial, sans-serif"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </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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# Indications for Use

510(k) Number (if known)

K22007

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 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 glenoid 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) and Univers Revers™ modular glenoid system (MGS) baseplates.

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

|X 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."

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# 510(k) Summary

| Date Prepared | March 7, 2023 |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Ivette Galmez<br>Regulatory Affairs Principal Specialist<br>1-239-643-5553, ext. 71263<br>[e-mail] |
| Name of Device | Arthrex Virtual Implant Positioning (VIP) System |
| Common Name | Total shoulder replacement system/instruments, Preoperative planning software/plan, Preoperative<br>Planning Web software |
| Product Code | QHE, KWS, PHX, LLZ |
| Classification Name | 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class | II |
| Primary Predicate | K162697: Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan,<br>SmartBase for Arthrex Glenoid Iris, Arthrex VIP Web Portal |
| Secondary Predicate | K212560: Signature™ ONE System |
| Reference Device | K193523: Arthrex VIP Web Portal |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for the VIP glenoid<br>reamers as a line extension to the Arthrex VIP System cleared under K162697. This submission includes<br>modifications to the VIP glenoid targeter (formerly glenoid IRI) which were previously documented via<br>letter to file, and VIP software updates. |
| Device Description | The subject VIP glenoid reamers are made of stainless-steel. The subject device is designed for use with<br>the Univers VaultLock glenoid and Univers Revers MGS baseplates. These glenoid components are<br>within the indications cleared for Arthrex VIP System under K162697 and K193523. The subject VIP<br>glenoid reamers consist of a primary reamer (pilot) and a secondary reamer (glenoid-implant specific:<br>Univers VaultLock [with/without augment] or Univers Revers MGS [with/without augment]). The<br>reaming depth settings for the subject devices is provided with the surgeon approved plan. |
| Indications for Use | The VIP Glenoid Targeter is a manual instrument system intended to facilitate preoperative planning<br>and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in<br>total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid<br>implant. The VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total<br>shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component,<br>as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular<br>glenoid system (MGS) baseplates.<br>The VIP Glenoid Reamer is intended for use with the VIP Glenoid Targeter in total shoulder systems<br>that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The VIP Glenoid<br>Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™<br>modular glenoid system (MGS) baseplates.<br>The indications for use of the Arthrex shoulder systems with which the VIP glenoid instrumentation is<br>intended to be used are the same as those described in the labeling for these shoulder systems.<br>The OrthoVis preoperative plan is a preoperative plan created via the OrthoVis software that facilitates<br>accurate preoperative planning and intraoperative placement of the glenoid component in total<br>shoulder replacement.<br>The VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shoulder<br>systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as<br>the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid<br>system (MGS) baseplates. The VIP Glenoid Reamer is indicated for use with the Univers VaultLock®<br>glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.<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. |
| | |
| Indications for Use<br>(continue) | 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>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 glenoid implant lines: Univers™ II and<br>Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock®<br>glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and<br>Univers Revers™ modular glenoid system (MGS) baseplates. |
| Summary of<br>Technological<br>Characteristics | The subject VIP glenoid reamers, except for the secondary reamers for the augmented MGS, are<br>reusable instruments. All VIP glenoid reamers are made of stainless steel. The subject VIP reamers are<br>used in conjunction with the VIP glenoid targeter instrument. The subject VIP reamers are used in place<br>of the standard glenoid reaming instrumentation. The subject reamers are designed with depth control<br>features having similar function to the disposable reaming guide instrumentation in Zimmer-Biomet<br>Signature One system (K212560). The settings for the reaming depth are reviewed during preoperative<br>planning and approved by the surgeon. The reaming depth settings for the subject devices is provided<br>with the surgeon approved plan. |
| | The subject VIP glenoid instrumentation has the same fundamental scientific technology (transfer a pre-<br>operative plan to the orthopedic surgical procedure) as the primary predicate (K162697) and secondary<br>predicate (K212560). |
| Performance Data | Design verification (compression testing and side-by-side testing) and cadaver validation were<br>performed. Compression testing was conducted to assess the function of the depth control features of<br>the VIP glenoid reamers. Side-by-side testing with the standard reaming method was conducted to<br>assess the primary reaming depth control accuracy of the VIP Reaming Instrumentation System. |
| | Cadaveric validation was performed to validate the related user needs, intended use, safety and<br>effectiveness of the subject VIP glenoid instrumentation. |
| | Software verification and validation testing of the Arthrex VIP Web Portal software and Arthrex<br>OrthoVis Desktop software were conducted and documentation was provided as recommended by<br>FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for<br>Software Contained in Medical Devices." The software was considered as a "major" level of concern.<br>Activities included software validation/verification, regression testing, unit testing, code reviews and<br>checks and integration testing. |
| Conclusion | The subject devices are substantially equivalent to the predicates in which the basic design features,<br>technological characteristics, principles of operation and intended use and indications are similar or the<br>same as the predicates. The verification and validation activities conducted for the subject VIP glenoid<br>reamers demonstrates that it performs as intended for the desired indications. The subject VIP glenoid<br>reamers, when used in conjunction with the Arthrex VIP System is substantially equivalent to the<br>predicate. The addition of the subject VIP glenoid reamer, as well as the modifications to the VIP<br>glenoid targeter and software updates do not raise new questions of safety or effectiveness. The<br>overall planning process, materials, sterilization methods, principles of operation, have not changed<br>from the predicates. Any differences with the predicate are considered minor and do not raise<br>questions regarding safety or effectiveness.<br><br>Based on the intended use and indications, technological characteristics, principle of operation and the<br>summary of data submitted, Arthrex Inc. has determined that the subject device is substantially<br>equivalent to the currently marketed predicate device. |

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