(36 days)
No
The 510(k) summary describes a mechanical implant system for shoulder replacement and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical and biological tests, not related to algorithmic performance.
Yes
The device is an implantable system for joint replacement, specifically indicated for the relief of pain and significant disability due to gross rotator cuff deficiency, which constitutes a therapeutic purpose.
No
The device is an implantable system for total shoulder replacement, designed to alleviate pain and disability. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states it is comprised of physical components (augmented modular glenoid baseplates and modular posts) made of materials like titanium. The performance studies also describe mechanical testing and bacterial endotoxin testing, which are relevant to physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a joint in the human body (glenohumeral joint). This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a system of baseplates and posts made of titanium, designed to be implanted. This aligns with a surgical implant, not a device used to test samples outside the body.
- Performance Studies: The performance studies mentioned (mechanical testing, bacterial endotoxin test, MRI testing) are typical for evaluating the safety and performance of an implantable medical device. They are not studies related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the Univers Revers Modular Glenoid System is a surgical implant designed for joint replacement, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 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 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 Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.
Product codes (comma separated list FDA assigned to the subject device)
PHX
Device Description
The proposed device is comprised of augmented modular glenoid baseplates and modular posts made of the same materials as the predicate (titanium/ BioSync). The baseplates are full wedge augmented versions of the cleared size 24 and size 28 modular baseplates. The posts are offered in lengths ranging from 20 mm to 40 mm. The proposed device is a line extension to the Univers Revers Modular Glenoid System was cleared under 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. Rocking horse testing per ASTM F2028, disengagement testing per ASTM F2009) was performed to demonstrate that the proposed device meets the standards requirements.
Bacterial Endotoxin test was conducted in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14 to demonstrate that the proposed device meets pyrogen limit specifications.
MRI testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment and ASTM F2182.
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.
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.
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
January 10, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Ivette Galmez Senior Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K193372
Trade/Device Name: Univers Revers Modular Glenoid System (Augmented baseplates) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX Dated: December 3, 2019 Received: December 5, 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 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
1
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 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
Indications for Use
510(k) Number (if known)
K193372
Device Name
Univers Revers Modular Glenoid System (Augmented baseplates)
Indications for Use (Describe)
The 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 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 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) |
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3
510(k) Summary
| Date Prepared | December 2, 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 | Univers Revers Modular Glenoid System (Augmented baseplates) |
| 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: Arthrex Univers Revers Shoulder Prosthesis System |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for |
| additional modular baseplates and posts as a line extension to the Univers Revers | |
| Modular Glenoid System cleared under K173900. | |
| Device Description | The proposed device is comprised of augmented modular glenoid baseplates and |
| modular posts made of the same materials as the predicate (titanium/ BioSync). The | |
| baseplates are full wedge augmented versions of the cleared size 24 and size 28 | |
| modular baseplates. The posts are offered in lengths ranging from 20 mm to 40 mm. | |
| The proposed device is a line extension to the Univers Revers Modular Glenoid | |
| System was cleared under K173900. | |
| Indications for Use | The 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 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 Univers Revers Modular Glenoid System is porous coated and is intended for | |
| cementless use with the addition of screws for fixation. | |
| Performance Data | Mechanical testing (i.e. Rocking horse testing per ASTM F2028, disengagement |
| testing per ASTM F2009) was performed to demonstrate that the proposed device | |
| meets the standards requirements. | |
| Bacterial Endotoxin test was conducted in accordance with ANSI/AAMI | |
| ST72:2011/(R)2016, USP , USP , EP 2.6.14 to demonstrate that the | |
| proposed device meets pyrogen limit specifications. | |
| MRI testing were conducted in accordance with FDA guidance Testing and Labeling | |
| Medical Devices for Safety in the Magnetic Resonance (MR) Environment and ASTM | |
| F2182. | |
| Conclusion | The Univers Revers Modular Glenoid System is substantially equivalent to the |
| predicate device in which the basic design features and intended use are the same. | |
| The mechanical testing data demonstrates that the proposed device performance is | |
| equivalent to the predicate device for the desired indications. 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. |