(119 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 indicated for use in surgical procedures to relieve pain and disability, which falls under the definition of a therapeutic device.
No
The device is a glenoid system intended for shoulder replacement, not for diagnosing conditions.
No
The device description clearly outlines physical components made of titanium, cobalt chrome, and UHMWPE, indicating it is a hardware medical device.
Based on the provided information, 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: The Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM is a surgical implant designed to replace a damaged glenohumeral joint (shoulder). It is physically implanted into the patient's body.
- Intended Use: The intended use is for surgical replacement of a joint to relieve pain and disability, not for testing biological samples.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic.
N/A
Intended Use / 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 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 (comma separated list FDA assigned to the subject device)
PHX
Device Description
The Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM consists of a monoblock baseplate or a modular baseplate; both baseplates are available with either a central screw or central post. The baseplate is designed to be used cementless with peripheral screws and a glenosphere. A humeral insert has been included in this system, to be used with the humeral side of the predicate Univers Revers Shoulder Prosthesis System (K142863).
The UNIVERS REVERS MODULAR GLENOID SYSTEM is comprised of known materials. The baseplates, central screws and posts are comprised of titanium with a BioSync coating, the peripheral screws are titanium and the glenospheres are available in either titanium or cobalt chrome. The humeral inserts are comprised of UHMWPE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint / glenohumeral joint
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, disassembly testing per ASTM F2009, torsional testing per ASTM F543, MR testing per ASTM F2182, F2052, and F2119) demonstrated that the Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM 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 POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY 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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April 20, 2018
Arthrex Inc. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K173900
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: March 20, 2018 Received: March 22, 2018
Dear Ms. 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 medical devices and radiation-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
2
Indications for Use
510(k) Number (if known) K173900
Device Name
Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM
Indications for Use (Describe)
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 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)
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Image /page/3/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 registered trademark symbol to the right of the "x". To the right of the word is an image of a surgical instrument.
510(k) Summary or 510(k) Statement
| Date Prepared | December 21, 2017 |
|---|---|
| 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 MODULAR GLENOID SYSTEM |
| 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 - K133349: Lima Glenoid SMR TT Metal Back | |
| Reference — K162455: FX Solutions Humeloc | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM. |
| Device Description | The Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM consists of a monoblock baseplate or a modular baseplate; both baseplates are available with either a central screw or central post. The baseplate is designed to be used cementless with peripheral screws and a glenosphere. A humeral insert has been included in this system, to be used with the humeral side of the predicate Univers Revers Shoulder Prosthesis System (K142863). |
| The UNIVERS REVERS MODULAR GLENOID SYSTEM is comprised of known materials. The baseplates, central screws and posts are comprised of titanium with a BioSync coating, the peripheral screws are titanium and the glenospheres are available in either titanium or cobalt chrome. The humeral inserts are comprised of UHMWPE. | |
| Indications for Use | The Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM 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. | |
| Performance Data | Mechanical testing (i.e., Rocking horse testing per ASTM F2028, disassembly testing per ASTM F2009, torsional testing per ASTM F543, MR testing per ASTM F2182, F2052, and F2119) demonstrated that the Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM performs equivalently to the predicate device. |
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Image /page/4/Picture/1 description: The image shows the logo for Arthrex. The logo is blue and consists of the word "Arthrex" in a sans-serif font, followed by a registered trademark symbol. To the right of the word is an image of a surgical tool.
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 POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY 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.