(119 days)
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.
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.
The provided text details a 510(k) premarket notification for a medical device, the Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness de novo. Therefore, the information provided focuses on comparative performance, particularly mechanical and material testing, rather than clinical study data from human subjects or AI algorithm performance as might be seen for devices utilizing AI.
Based on the provided text, there is no information regarding acceptance criteria or a study proving an AI device meets acceptance criteria. The document describes a shoulder prosthesis, not an AI device.
However, if we interpret "acceptance criteria" and "study" in the context of this non-AI medical device (shoulder prosthesis), we can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) submission):
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Performance | Rocking horse testing per ASTM F2028 | Demonstrated equivalence to the predicate device. |
| Disassembly testing per ASTM F2009 | Demonstrated equivalence to the predicate device. | |
| Torsional testing per ASTM F543 | Demonstrated equivalence to the predicate device. | |
| Material Safety/Compatibility | MR testing per ASTM F2182, F2052, and F2119 (Magnetic Resonance compatibility) | Demonstrated equivalence to the predicate device. |
| Baseplate coating compliance with FDA Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants | The baseplate coating is in compliance with the guidance to support reconsideration of postmarket surveillance requirements. | |
| Bacterial endotoxin per EP 2.6.14/USP <85> (Pyrogen limit specifications) | Demonstrated that the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY meets pyrogen limit specifications. | |
| Substantial Equivalence | Comparison of indications for use, technological characteristics, and performance data to predicate devices (K142863, K133349, K162455) | The proposed device is substantially equivalent to the predicate devices in which the basic design features and intended uses are the same. Differences are considered minor and do not raise questions concerning safety or effectiveness. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the precise number of physical samples used for each mechanical and material test (e.g., how many glenoid components were subjected to rocking horse testing). It refers to tests being "conducted" but not the exact quantity of items.
- Data Provenance: The data comes from non-clinical testing (mechanical and material laboratory tests) performed by the manufacturer, Arthrex Inc. The location of the testing facility is not specified, but the company is based in Naples, Florida, USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device. The "ground truth" for a mechanical orthopedic implant is established by engineering standards (e.g., ASTM standards) and validated test methodologies, not by expert human interpretation of results like in an AI imaging study. The tests evaluate physical properties against established benchmarks for similar devices.
4. Adjudication method for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for subjective assessments or expert consensus in AI model validation. For mechanical and material testing, the acceptance is based on quantitative measurements meeting predefined criteria from industry standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This question is not applicable. This is a physical medical implant, not an AI-assisted diagnostic tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This device is a mechanical prosthesis, not an algorithm or software. "Standalone performance" in this context would refer to the purely mechanical performance of the device itself, which is what the mechanical and material tests evaluated.
7. The type of ground truth used:
- The ground truth for this device is based on engineering standards and established performance benchmarks for similar predicate orthopedic implants. Specifically:
- Mechanical Integrity: Compliance with ASTM standards (F2028, F2009, F543) ensures the device's physical strength, stability, and resistance to wear meet accepted anatomical and functional requirements for shoulder prostheses.
- Biocompatibility/Material Safety: Compliance with pyrogen limits (EP 2.6.14/USP <85>) and FDA guidance on plasma sprayed coatings ensures the materials are safe for implantation and do not elicit adverse biological responses.
- Magnetic Resonance Compatibility: Compliance with ASTM standards (F2182, F2052, F2119) ensures the device is safe for patients undergoing MRI procedures.
8. The sample size for the training set:
- This question is not applicable. There is no "training set" in the context of demonstrating substantial equivalence for a mechanical prosthetic device. The design and manufacturing processes are informed by existing biomechanical knowledge, material science, and the performance of predicate devices, not by a data-driven training process for an algorithm.
9. How the ground truth for the training set was established:
- This question is not applicable as there is no "training set." The engineering principles and material science knowledge applied in the design and testing of such devices are established through decades of research, manufacturing experience, and regulatory guidance, rather than a specific "ground truth" for a training set.
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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.
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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
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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 <85> 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.
§ 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.”