(136 days)
Not Found
No
The document describes a manual instrument system and software for preoperative planning and intraoperative guidance, but there is no mention of AI or ML in the intended use, device description, or performance studies. The software appears to be for displaying and editing plans generated by technicians, not for automated analysis or decision-making using AI/ML.
No.
The devices are instruments and software intended for preoperative planning and intraoperative placement of glenoid components in total shoulder replacement, rather than directly treating a disease or condition.
No.
The device is an instrument system and software intended for preoperative planning and intraoperative placement of glenoid implants in total shoulder replacement, and a web portal for displaying/editing implant placement and surgical treatment options. It does not diagnose medical conditions.
No
The device description explicitly states it is an "instrument system" and mentions "components of the system," indicating the presence of hardware in addition to the software elements (OrthoVis Preoperative Plan, VIP Web Portal).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device's intended use: The Glenoid IRIS system is intended for surgical planning and intraoperative guidance during total shoulder replacement surgery. It facilitates the placement of a guide pin and subsequently the glenoid implant.
- No mention of biological samples: The description focuses on using imaging data (CT scans) and software to plan and guide a surgical procedure. There is no mention of analyzing biological samples from the patient.
Therefore, the device falls under the category of surgical instruments and planning software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific 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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex. Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.
The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.
The Arthrex Ortho Vis Preoperative Plan is a preoperative plan created via the OrthoVis software accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.
The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex. Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.
The indications for use of the Arthrex shoulder systems with which the Arthex Ortho Vis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.
The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific 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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex. Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.
The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.
The Arthrex VIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scamer such as a CT scanner. It is also intended as software for displaying implant placement and surgical treatment options that were generated in the Ortho Vis Desktop Software by trained COS technicians. The Arthrex VIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.
Product codes (comma separated list FDA assigned to the subject device)
KWS, PHX, LLZ
Device Description
The Glenoid IRIS is an instrument system intended for use in total shoulder replacement to facilitate preoperative planning and intraoperative placement of the glenoid implant component.
This bundled submission contains four traditional 510(k) submissions associated with Arthrex Glenoid IRIS. All of the submissions correspond to components of the system that are intended for use together to place the guide pin, and subsequently the glenoid implant, in a total shoulder replacement surgery. All of the components (subject devices in the bundled submissions) of Arthrex Glenoid IRIS are indicated for use with the Arthrex lines of Glenoid implants. We would now like to add the Arthrex Vault Lock glenoid implant to this list of compatible/indicated implant systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanner such as a CT scanner
Anatomical Site
glenoid, total shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained COS technicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Verified with manufacturer (Arthrex) that new implant should be placed by COS technicians, using the same protocol as the other anatomic implants previously cleared with the bundled devices.
- Manual software verification and validation testing of Arthrex OrthoVis Desktop . Software
- Automatic verification and validation testing of Arthrex VIP Web Software
- Dimensional validation of implants in OrthoVis Desktop Software
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K142072, K133367, K151501, K151568, K151500
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
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.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2017
Custom Orthopaedic Solutions, Inc. Keith Grafmeyer Project/regulatory Manager 7100 Euclid Ave., Ste. 180 Cleveland, Ohio 44103
Re: K162697
Trade/Device Name: Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoid Iris, ArthrexVIP Web Portal Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS, PHX, LLZ Dated: September 14, 2016 Received: September 27, 2016
Dear Keith Grafmeyer:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162697
Device Name
Arthrex Glenoid Intelligent Reusable Instrument System (IRIS)
Indications for Use (Describe)
The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific 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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex. Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.
The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS 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)
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162697
Device Name
Arthrex Ortho Vis Preoperative Plan
Indications for Use (Describe)
The Arthrex Ortho Vis Preoperative Plan is a preoperative plan created via the OrthoVis software accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.
The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex. Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.
The indications for use of the Arthrex shoulder systems with which the Arthex Ortho Vis 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)
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
4
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162697
Device Name SmartBase for Arthrex Glenoid IRIS
Indications for Use (Describe)
The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific 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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex. Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.
The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS 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)
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
Image /page/4/Picture/20 description: The image is a close-up shot of a black rectangular object. The object appears to be made of a solid material. The lighting in the image is dim, which makes it difficult to discern any details on the object's surface. The object is positioned horizontally in the frame.
5
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162697
Device Name Arthrex VIP Web Portal
Indications for Use (Describe)
The Arthrex VIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scamer such as a CT scanner. It is also intended as software for displaying implant placement and surgical treatment options that were generated in the Ortho Vis Desktop Software by trained COS technicians. The Arthrex VIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.
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
6
510(k) Summary
| 510(k) SPONSOR / MANUFACTURER: | Custom Orthopaedic Solutions, Inc.
7100 Euclid Ave
Ste 180
Cleveland OH, 44103 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Keith Grafmeyer
Project/Requlatory Manager
Custom Orthopaedic Solutions
Tel: (216) 800-5905 Ext. 102
Email: kgrafmeyer@customorthopaedics.com |
| TRADE NAMES: | Arthrex Glenoid Intelligent Reusable Instrument
System, Arthrex OrthoVis Preoperative Plan,
SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web
Portal |
| DATE PREPARED: | 6-Jan-17 |
| COMMON NAMES: | Total shoulder replacement system / instruments,
Preoperative planning software/plan, Preoperative
Planning Web Software |
| Product | Product
Code | Regulation and Classification Name | Device
Class |
|----------------------------------------------------------------------------------------------|-----------------|---------------------------------------------------------------------------------------------|-----------------|
| K151500: Arthrex Glenoid
Intelligent Reusable Instrument
System (Arthrex Glenoid IRIS) | KWS,
PHX | 21 CFR 888.3660
Shoulder Joint Metal/Polymer,
Semi-Constrained Cemented
Prosthesis | II |
| K151568: Arthrex OrthoVis
Preoperative Plan | LLZ | 21 CFR 892.2050
Picture Archiving &
Communications System | II |
| K153612: ArthrexVIP Web
Portal | LLZ | 21 CFR 892.2050
Picture Archiving &
Communications System | II |
7
| K153215: SmartBase for Arthrex
Glenoid IRIS | KWS,
PHX | 21 CFR 888.3660
Shoulder Joint Metal/Polymer,
Semi-Constrained Cemented
Prosthesis | II |
| ------------------------------------------------ | ------------- | --------------------------------------------------------------------------------------------- | ---- |
|---|
PREDICATE DEVICES:
| Subject Device | Corresponding Predicate Device(s) |
|---|---|
| K151500 | K142072: Glenoid Intelligent Reusable |
| Instrument System (Glenoid IRIS) | |
| K151568 | K133367: OrthoVis Preoperative Plan |
| K153612 | K151501: OrthoVis Web Portal, K151568: |
| Arthrex OrthoVis Preoperative Plan, | |
| K151500: Arthrex Glenoid Intelligent | |
| Reusable Instrument System (Arthrex | |
| Glenoid IRIS) | |
| K153215 | K151500: Arthrex Intelligent Reusable |
| Instrument System (Arthrex Glenoid IRIS) |
DEVICE DESCRIPTION:
The Glenoid IRIS is an instrument system intended for use in total shoulder replacement to facilitate preoperative planning and intraoperative placement of the glenoid implant component.
This bundled submission contains four traditional 510(k) submissions associated with Arthrex Glenoid IRIS. All of the submissions correspond to components of the system that are intended for use together to place the guide pin, and subsequently the glenoid implant, in a total shoulder replacement surgery. All of the components (subject devices in the bundled submissions) of Arthrex Glenoid IRIS are indicated for use with the Arthrex lines of Glenoid implants. We would now like to add the Arthrex Vault Lock glenoid implant to this list of compatible/indicated implant systems.
INTENDED USE AND INDICATIONS:
K151500
The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific 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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.
8
The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.
K151568
The Arthrex 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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.
The indications for use of the Arthrex shoulder systems with which the Arthex OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.
K153612
The ArthrexVIP 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 COS technicians. The ArthrexVIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.shoulder systems.
Identical to K151500 above.
BASIS OF SUBSTANTIAL EQUIVALENCE:
All of the devices in this bundled submission are still substantialy equivalent to their predicates because their underlying scientific characteristics have not changed. The only change to these devices is the addition of Arthrex Vault Lock as an indicated glenoid implant line. The CAD models have been added to the templating software and the design has not changed otherwise.
SUMMARY OF VERIFICATION/VALIDATION TESTING
- . Verified with manufacturer (Arthrex) that new implant should be placed by COS technicians, using the same protocol as the other anatomic implants previously cleared with the bundled devices.
9
- Manual software verification and validation testing of Arthrex OrthoVis Desktop . Software
- . Automatic verification and validation testing of Arthrex VIP Web Software
- . Dimensional validation of implants in OrthoVis Desktop Software