(227 days)
No
The summary describes a mechanical implant (shoulder prosthesis component) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a component of a shoulder prosthesis system intended for total shoulder replacement to relieve pain and disability, which are therapeutic goals.
No
Explanation: The device is a glenoid component for a shoulder prosthesis system, designed for surgical implantation to replace a damaged joint, not to diagnose a condition.
No
The device description clearly states it is a "coated titanium glenoid baseplate," which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Arthrex UNIVERS REVERS COATED BASEPLATE is a surgical implant designed to be placed inside the body as part of a shoulder prosthesis system. It is used to replace a damaged joint component.
- Lack of Diagnostic Function: The device itself does not perform any tests on bodily samples to diagnose a condition or provide information about a patient's health status based on those tests. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Arthrex UNIVERS REVERS COATED BASEPLATE is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex UNIVERS REVERS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System.
The Arthrex UNIVERS REVERS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Arthrex UNIVERS REVERS COATED BASEPLATE 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 COATED BASEPLATE is coated and is intended for cementless use with the addition of screws for fixation.
Product codes
PHX
Device Description
The Arthrex UNIVERS REVERS COATED BASEPLATE is a coated titanium glenoid baseplate designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System. The baseplate is centrally anchored by a barbed post with superior and inferior multi-directional screws to ensure optimal fixation. The baseplate comes in three sizes and is designed to be paired with the Univers Revers glenosphere.
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 (Rocking Horse, Shear Force) demonstrated that the Arthrex UNIVERS REVERS COATED BASEPLATE performs equivalently to the predicate device.
Non-clinical testing demonstrates that the baseplate coating is in compliance with the FDA Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements.
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the Arthrex UNIVERS REVERS COATED BASEPLATE meets pyrogen limit specifications.
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.”
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
March 22, 2018
Arthrex, Inc. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K172371
Trade/Device Name: Arthrex UNIVERS REVERS COATED BASEPLATE Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX Dated: February 16, 2018 Received: February 20, 2018
Dear Courtney Smith:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172371
Device Name Arthrex Univers Revers Coated Baseplate
Indications for Use (Describe)
The Arthrex UNIVERS REVERS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System.
The Arthrex UNIVERS REVERS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Arthrex UNIVERS REVERS COATED BASEPLATE 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 COATED BASEPLATE is 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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Image /page/3/Picture/1 description: The image shows the Arthrex logo in blue. The logo consists of the word "Arthrex" in a bold, sans-serif font, followed by the registered trademark symbol. To the right of the wordmark is a stylized graphic of surgical instruments, including what appears to be a syringe and a pair of scissors.
510(k) Summary or 510(k) Statement
| Date Prepared | March 19, 2018 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Courtney Smith |
| Manager, Regulatory Affairs | |
| 1-239-643-5553, ext. 71720 | |
| Courtney.smith@arthrex.com | |
| Name of Device | Arthrex UNIVERS REVERS COATED BASEPLATE |
| Common Name | Shoulder Prosthesis |
| Product Code | PHX |
| Classification Name | Prosthesis, Shoulder, semi-constrained metal/polymer, cemented, CFR 888.3660 |
| Regulatory Class | II |
| Predicate Device | Primary - K142863: Arthrex Univers Revers Prosthesis Shoulder System |
| Reference - K053274: Zimmer Anatomical Shoulder System | |
| Purpose of | |
| Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex UNIVERS REVERS COATED BASEPLATE. | |
| Device Description | The Arthrex UNIVERS REVERS COATED BASEPLATE is a coated titanium glenoid |
| baseplate designed to be used as the glenoid component of the existing Univers Revers | |
| Shoulder Prosthesis System. The baseplate is centrally anchored by a barbed post with | |
| superior and inferior multi-directional screws to ensure optimal fixation. The baseplate | |
| comes in three sizes and is designed to be paired with the Univers Revers | |
| glenosphere. | |
| Indications for Use | The Arthrex UNIVERS REVERS COATED BASEPLATE is designed to be used as the |
| glenoid component of the existing Univers Revers Shoulder Prosthesis System. | |
| The Arthrex UNIVERS REVERS COATED BASEPLATE 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 COATED BASEPLATE 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 COATED BASEPLATE is coated and is intended for | |
| cementless use with the addition of screws for fixation. | |
| Performance Data | Mechanical testing (Rocking Horse, Shear Force) demonstrated that the Arthrex |
| UNIVERS REVERS COATED BASEPLATE performs equivalently to the predicate | |
| device. | |
| Non-clinical testing demonstrates that the baseplate coating is in compliance | |
| with the FDA Guidance for Industry on Testing of Metallic Plasma Sprayed | |
| Coatings on Orthopedic Implants to Support Reconsideration of Postmarket | |
| Surveillance Requirements. | |
| Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that | |
| the Arthrex UNIVERS REVERS COATED BASEPLATE meets pyrogen limit | |
| specifications. | |
| Conclusion | The proposed device is substantially equivalent to the predicate devices in which |
| the basic design features and intended uses are the same. Any differences | |
| between the proposed device and the predicate device are considered minor and | |
| do not raise questions concerning 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. |
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Image /page/4/Picture/1 description: The image shows the Arthrex logo in blue. The logo features the word "Arthrex" in a bold, sans-serif font, with a stylized image of surgical instruments forming the "x" in the name. The registered trademark symbol is present to the right of the word. The logo is clean and professional, reflecting the company's focus on medical technology.