(106 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 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.
The Arthrex Titanium Glenospheres are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A titanium glenosphere is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
The proposed Titanium Glenosphere is manufactured from Ti-6Al-4V ELI per ASTM F136 and will be offered in sizes ranging from 33-42mm. The Titanium Glenospheres are intended to be used with the same components as originally cleared under K173900. The proposed Titanium Glenosphere share the same dimensional specifications to the cleared CoCr Glenospheres (K173900).
This document describes the Arthrex Modular Glenoid System - Titanium Glenosphere, a medical device, and the testing conducted to support its substantial equivalence. As such, the study focuses on engineering performance criteria rather than human reader/AI performance.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance data and general conclusions about the device's equivalence, but it does not specify explicit numerical acceptance criteria for each test. Instead, it indicates that tests were conducted to evaluate properties and that the device meets specifications or is substantially equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adequate Fatigue Properties (of the Titanium Glenosphere) | Fatigue testing was conducted. The specific results and acceptance values are not provided, but the conclusion states that the device is substantially equivalent to the predicate, implying adequate fatigue properties were demonstrated. |
| Adequate Disassembly Force (of the Titanium Glenosphere) | Push-out testing was conducted to evaluate the disassembly force. Specific results and acceptance values are not provided, but the conclusion states that the device is substantially equivalent, implying adequate disassembly force was demonstrated. |
| Substantial Equivalence in Hardness (compared to predicate) | An engineering analysis was performed to address substantial equivalence. |
| Substantial Equivalence in Adhesion (compared to predicate) | An engineering analysis was performed to address substantial equivalence. |
| Substantial Equivalence in Surface Roughness (compared to predicate) | An engineering analysis was performed to address substantial equivalence. |
| Substantial Equivalence in Scratch Resistance (compared to predicate) | An engineering analysis was performed to address substantial equivalence. |
| Substantial Equivalence in Young's Modulus (compared to predicate) | An engineering analysis was performed to address substantial equivalence. |
| Meets Pyrogen Limit Specifications (for bacterial endotoxin) | Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications. (Specific limit and result not provided, but the meeting of specifications is stated). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Fatigue testing and push-out testing were conducted," and "an engineering analysis was performed." For these types of mechanical tests, sample sizes are typically determined by relevant ISO standards or internal validation protocols. The exact number of parts tested is not provided.
- Data Provenance: The studies are described as "Performance Data" and "non-clinical data," which typically refers to laboratory or bench testing. The origin of the data is implicitly from Arthrex Inc.'s internal testing or a contract testing laboratory, rather than patient data from a specific country. This is retrospective in the sense that the tests were completed before submission, but not derived from an existing patient dataset.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device submission. The tests are mechanical and material property tests, not diagnostic imaging or clinical assessment studies that would require human expert ground truth. The "ground truth" here is established by the physical and chemical properties of the materials and the mechanical performance of the device under defined conditions, measured by instrumentation and validated test methods.
4. Adjudication Method for the Test Set
This is not applicable. As stated above, this is not a study requiring human adjudication of clinical outcomes or images. The "adjudication" in this context would be the review and approval of the test methods, raw data, and final reports by qualified engineers and quality personnel within Arthrex and by the FDA.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
This is not applicable. The device is an orthopedic implant (shoulder glenosphere), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness assessment was performed or would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is not applicable. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on engineering and material specifications from recognized standards (e.g., ASTM F136 for the material, EP 2.6.14/USP <85> for bacterial endotoxin) and the established performance of the predicate device (K173900). The goal is to demonstrate that the new device's properties and performance meet predefined mechanical and biological safety criteria and are substantially equivalent to the cleared predicate device.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of an orthopedic implant's mechanical testing for 510(k) clearance. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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November 17, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Arthrex Inc. David Rogers Director, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K212415
Trade/Device Name: Arthrex Modular Glenoid System - Titanium Glenosphere 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 2, 2021 Received: November 4, 2021
Dear David Rogers:
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
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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 Jiping Chen, Ph.D., M.P.H. Acting Division 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
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Indications for Use
510(k) Number (if known) K212415
Device Name
Arthrex Modular Glenoid System - Titanium Glenosphere
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 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.
The Arthrex Titanium Glenospheres are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A titanium glenosphere is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary 1.
| Date Prepared | November 17, 2021 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Ivette GalmezPrincipal Specialist, Regulatory Affairs1-239-643-5553ivette.galmez@arthrex.com |
| Name of Device | Arthrex Modular Glenoid System - Titanium Glenosphere |
| Common Name | Shoulder Prosthesis |
| Product Code | PHX |
| Classification Name | 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class | Class II |
| Predicate Device | K173900: Arthrex Modular Glenoid System |
| Reference Device | K182799: Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsK203100: Arthrex Eclipse Titanium Humeral Head |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain FDA clearance for aline extension of a Titanium Glenosphere for the Arthrex Modular Glenoid Systemcleared under K173900. |
| Device Description | The proposed Titanium Glenosphere is manufactured from Ti-6Al-4V ELI per ASTM F136and will be offered in sizes ranging from 33-42mm. The Titanium Glenospheres areintended to be used with the same components as originally cleared under K173900.The proposed Titanium Glenosphere share the same dimensional specifications to thecleared CoCr Glenospheres (K173900). |
| Indications for Use | The Arthrex Univers Revers Modular Glenoid System is indicated for use in a grosslyrotator cuff deficient glenohumeral joint with severe arthropathy or a previously failedjoint replacement with a gross rotator cuff deficiency. The patient's joint must beanatomically and structurally suited to receive the selected implant(s), and a functionaldeltoid 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 dueto gross rotator cuff deficiency.The Arthrex Univers Revers Modular Glenoid System is porous coated and is intendedfor cementless use with the addition of screws for fixation.The Arthrex Titanium Glenospheres are indicated for patients with suspected cobaltalloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to thatof cobalt alloy. A titanium glenosphere is not recommended for patients who lacksuspected material sensitivity to cobalt alloy. |
| Performance Data | Fatigue testing and push-out testing were conducted to evaluate the fatigue propertiesand disassembly force of the Arthrex Titanium Glenosphere.Additionally, an engineering analysis was performed to address the substantialequivalence of hardness, adhesion, surface roughness, scratch resistance, and young'smodulus compared to the predicate device.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that thedevice meets pyrogen limit specifications. |
| Conclusion | The Arthrex Titanium Glenosphere has the same intended use and the samefundamental scientific technology as the Arthrex Modular Glenoid System. Based on thenon-clinical data presented in this 510(k), Arthrex concludes that the proposed device is |
§ 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.”