(106 days)
No
The document describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an implant for total shoulder replacement to relieve pain and disability, which aligns with the definition of a therapeutic device.
No
This device is a surgical implant (glenoid system and glenospheres) used for total shoulder replacement. It is designed to treat severe arthropathy and rotator cuff deficiency, not to diagnose these conditions.
No
The device description clearly states it is a physical implant (Titanium Glenosphere) made from Ti-6Al-4V ELI, intended for surgical implantation in the shoulder joint. It also describes physical testing (fatigue, push-out) and material properties, which are characteristic of hardware devices, not software.
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, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Arthrex Univers Revers Modular Glenoid System is an implantable device used for total shoulder replacement. It is surgically implanted into the glenohumeral joint to address severe arthropathy and rotator cuff deficiency.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any diagnostic tests. Its function is purely therapeutic and reconstructive.
Therefore, this device falls under the category of a surgical implant or prosthetic device, 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 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.
Product codes
PHX
Device Description
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).
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
Fatigue testing and push-out testing were conducted to evaluate the fatigue properties and disassembly force of the Arthrex Titanium Glenosphere. Additionally, an engineering analysis was performed to address the substantial equivalence of hardness, adhesion, surface roughness, scratch resistance, and young's modulus compared to the predicate device. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
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 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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary 1.
| Date Prepared | November 17, 2021 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Ivette Galmez |
| Principal Specialist, Regulatory Affairs | |
| 1-239-643-5553 | |
| ivette.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 Heads |
| K203100: Arthrex Eclipse Titanium Humeral Head | |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain FDA clearance for a |
| line extension of a Titanium Glenosphere for the Arthrex Modular Glenoid System | |
| cleared under K173900. | |
| Device Description | 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). | |
| 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 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. | |
| Performance Data | Fatigue testing and push-out testing were conducted to evaluate the fatigue properties |
| and disassembly force of the Arthrex Titanium Glenosphere. | |
| Additionally, an engineering analysis was performed to address the substantial | |
| equivalence of hardness, adhesion, surface roughness, scratch resistance, and young's | |
| modulus compared to the predicate device. | |
| Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the | |
| device meets pyrogen limit specifications. | |
| Conclusion | The Arthrex Titanium Glenosphere has the same intended use and the same |
| fundamental scientific technology as the Arthrex Modular Glenoid System. Based on the | |
| non-clinical data presented in this 510(k), Arthrex concludes that the proposed device is |