(153 days)
No
The summary describes a mechanical implant system for shoulder replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is clearly indicated for the "relief of pain and significant disability due to gross rotator cuff deficiency" in total shoulder replacement, which is a therapeutic purpose.
No
The device description and intended use indicate that this is an implantable prosthetic system for shoulder replacement, not a device used to diagnose medical conditions.
No
The device description clearly states it is a "Modular Glenoid System" consisting of physical components like baseplates, glenospheres, and humeral inserts, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is an implantable prosthesis for surgical use in the glenohumeral joint (shoulder). It is used to replace a damaged joint.
- Device Description: The description details the physical components of the implant (baseplate, glenosphere, humeral insert).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
This device falls under the category of a surgical implant/prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex Univers Revers Modular Glenoid System is in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's ioint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Arthrex Univers Revers Modular Glenoid System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The Arthrex Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.
Product codes
PHX
Device Description
The Arthrex Univers Revers Modular Glenoid System cleared under K173900 consists of a monoblock or modular baseplate that is centrally anchored by a central screw or post for cementless use with peripheral screws, a glenosphere, and humeral insert as part of the Univers Revers Shoulder Prosthesis System, K142863. This Special 510(k) introduces size 45 glenospheres manufactured from Cobalt Chromium (CoCr) and as well as combination humeral inserts manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE), same materials as K173900.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Mechanical testing (i.e. Fatigue testing and Corrosion per ASTM F2028, and PE/Cup interface per ASTM F1820-13 testing) demonstrated that the Size 45 Glenospheres and Combination Humeral Inserts perform equivalently to the predicate device. Bacterial Endotoxin per EP 2.6.14/USP demonstrates that the Size 45 Glenospheres and Combination Humeral Inserts meets pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 below that.
December 23, 2019
Arthrex Inc. Ivette Galmez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K191960
Trade/Device Name: Arthrex Univers Revers Modular Glenoid System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX Dated: November 21, 2019 Received: November 25, 2019
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
FOR Michael Owens Acting 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
2
Arthrex Inc. Special 510(k) DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191960
Device Name
Arthrex Univers Revers Modular Glenoid System
Indications for Use (Describe)
The Arthrex Univers Revers Modular Glenoid System is in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's ioint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Arthrex Univers Revers Modular Glenoid System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The Arthrex Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.
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
"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."
3
510(k) Summary
| Date Prepared | July 19, 2019 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Ivette Galmez |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 71263 | |
| Ivette.galmez@arthrex.com | |
| Name of Device | Arthrex Univers Revers Modular Glenoid System |
| Common Name | Shoulder Prosthesis |
| Product Code | PHX |
| Classification Name | 21 CFR 888.3660: Prosthesis, Shoulder, semi-constrained metal/polymer, cemented |
| Regulatory Class | II |
| Predicate Device | K173900: Arthrex Univers Revers Modular Glenoid System |
| Reference Device | K142863: Univers Revers Shoulder Prosthesis System |
| K161782: Arthrex Univers Revers Shoulder Prosthesis System | |
| K171841: Arthrex Shoulder System | |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for size 45 |
| glenospheres and combination humeral inserts as a line extension to the Arthrex Univers | |
| Revers Modular Glenoid System cleared under K173900. | |
| Device Description | The Arthrex Univers Revers Modular Glenoid System cleared under K173900 consists of a |
| monoblock or modular baseplate that is centrally anchored by a central screw or post for | |
| cementless use with peripheral screws, a glenosphere, and humeral insert as part of the | |
| Univers Revers Shoulder Prosthesis System, K142863. | |
| This Special 510(k) introduces size 45 glenospheres manufactured from Cobalt Chromium | |
| (CoCr) and as well as combination humeral inserts manufactured from Ultra High Molecular | |
| Weight Polyethylene (UHMWPE), same materials as K173900. | |
| Indications for Use | The Arthrex Univers Revers Modular Glenoid System is indicated for use in a grossly rotator |
| cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint | |
| replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically and | |
| structurally suited to receive the selected implant(s), and a functional deltoid muscle is | |
| necessary to use the device. | |
| The Arthrex Univers Revers Modular Glenoid System is indicated for primary, fracture, or | |
| revision total shoulder replacement for the relief of pain and significant disability due to gross | |
| rotator cuff deficiency. | |
| The Arthrex Univers Revers Modular Glenoid System is porous coated and is intended for | |
| cementless use with the addition of screws for fixation. | |
| Substantial Equivalence | The Arthrex Univers Revers Modular Glenoid System is substantially equivalent to the |
| Summary | predicate device in which the basic design features and intended use are the same. Any |
| differences between the Size 45 Glenospheres and Combination Humeral Inserts and the | |
| predicates are considered minor and do not raised questions concerning safety and | |
| effectiveness. | |
| Mechanical testing (i.e. Fatigue testing and Corrosion per ASTM F2028, and PE/Cup interface | |
| per ASTM F1820-13 testing) demonstrated that the Size 45 Glenospheres and Combination | |
| Humeral Inserts perform equivalently to the predicate device. | |
| Bacterial Endotoxin per EP 2.6.14/USP demonstrates that the Size 45 Glenospheres and | |
| Combination Humeral Inserts meets pyrogen limit specifications. | |
| Conclusion | The proposed device is substantially equivalent to the predicate device in which the basic |
| design features and intended use are the same. Any differences between the proposed device | |
| and the predicate device are considered minor and do not raise questions regarding safety or | |
| effectiveness. | |
| Based on the indications for use, technological characteristics, and the summary of data | |
| submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent to | |
| the currently marketed predicate device. |