(60 days)
No
The 510(k) summary describes a mechanical orthopedic implant (shoulder prosthesis components) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies focus on mechanical and material properties.
Yes
The device is a medical implant (glenoid component baseplate and inlay) used in shoulder replacement surgery to relieve pain and disability, which aligns with the definition of a therapeutic device.
No
Explanation: The device is an orthopedic implant designed for total shoulder replacement, specifically addressing severe arthropathy and rotator cuff deficiency. It is a glenoid component, not a device used for diagnosis.
No
The device description clearly states it consists of a porous coated titanium glenoid baseplate and a UHMWPE inlay bearing, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is a physical implant designed to be surgically placed in the glenohumeral joint (shoulder). Its purpose is to replace damaged joint components and restore function, not to analyze biological samples for diagnostic purposes.
- Lack of Diagnostic Function: The description focuses on the mechanical properties, materials, and surgical application of the device. There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
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 POROUS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System.
The Arthrex UNIVERS REVERS POROUS 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 POROUS 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 POROUS COATED BASEPLATE is porous coated and is intended for cementless use with the addition of screws for fixation.
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated for use in anatomic joint replacement(s) when conditions including severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, fracture or injury of the glenohumeral joint; non-union humeral head fractures of long duration; avascular necrosis of the humeral head; neoplastic or dysplastic diseases; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
For anatomic joint replacement, the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated to be used with the humeral components of the Arthrex Univers II Shoulder Prosthesis System for total shoulder arthroplasty. The UNIVERSAL GLENOID INLAY is intended for use with the UNIVERS REVERS POROUS COATED BASEPLATE.
Product codes (comma separated list FDA assigned to the subject device)
PHX, MBF
Device Description
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY consists of a porous coated titanium glenoid baseplate and a UHMWPE inlay bearing. The baseplate is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System. The baseplate is centrally anchored by a barbed post with superior and inferior multi-directional screws to ensure optimal fixation. The baseplate and inlay bearing come in three sizes to match anatomical size variations.
For a reversed shoulder application, the baseplate can be paired with the Univers Revers glenosphere.
For an anatomic shoulder application, the baseplate should be paired with the inlay bearing. The inlay bearing is available in two thicknesses (standards and +2mm) and in sizes corresponding to the glenoid baseplate. Pegs on the underside of the inlay bearing snap into corresponding recesses in the baseplate, ensuring a secure attachment to the bearing inlay, while at the same time minimizing angular rotation.
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
Prescription Use
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)
Performance testing (shear force, comparative, glenoid dynamic loosening testing and locking mechanism disassembly testing) demonstrated that the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY 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.
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.”
0
September 28, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Arthrex Inc. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples. Florida 34108-1945
Re: K182039
Trade/Device Name: Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, MBF Dated: July 26, 2018 Received: July 30, 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Daniel S. Ramsey -S 2018.09.28 10:01:59 -04'00'
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) K182039
Device Name
Arthrex UNIVERS REVERS POROUS COATED BASEPLATE and UNIVERSAL GLENOID INLAY
Indications for Use (Describe)
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System.
The Arthrex UNIVERS REVERS POROUS 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 POROUS 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 POROUS COATED BASEPLATE is porous coated and is intended for cementless use with the addition of screws for fixation.
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated for use in anatomic joint replacement(s) when conditions including severe pain or significant disability resulting from degenerative, rheumatic disease, fracture or injury of the glenohumeral joint; non-union humeral head fractures of long duration; avascular necrosis of the humeral head; neoplastic diseases; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
For anatomic joint replacement, the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated to be used with the humeral components of the Arthrex II Shoulder Prosthesis System for total shoulder arthroplasty. The UNIVERSAL GLENOID INLAY is intended for use with the UNIVERS REVERS POROUS COATED BASEPLATE.
Type of Use (Select one or both, as applicable)
| Destination Host (21 CFR 301 Subpart B) | Own-Firm Consignment (21 CFR 301 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------- |
|X | 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. The logo is blue and features the word "Arthrex" in a stylized font. To the right of the word is an image of a surgical tool. The logo is simple and professional.
510(k) Summary or 510(k) Statement
| Date Prepared | September 27, 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 POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY |
| Common Name | Shoulder Prosthesis |
| Product Code | PHX, MBF |
| Classification Name | Prosthesis, Shoulder, semi-constrained metal/polymer, cemented, CFR 888.3660 Prosthesis, Shoulder, semi-constrained metal/polymer, uncemented, CFR 888.3670 |
| Regulatory Class | II |
| Predicate Device | Primary – K172371: Arthrex Univers Revers Coated Baseplate Reference – K161120: Lima SMR TT Metal Back Glenoid K162068: Arrow Anatomical Porous Glenoid |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY. |
| Device Description | The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY consists of a porous coated titanium glenoid baseplate and a UHMWPE inlay bearing. The baseplate is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System. The baseplate is centrally anchored by a barbed post with superior and inferior multi-directional screws to ensure optimal fixation. The baseplate and inlay bearing come in three sizes to match anatomical size variations. |
| For a reversed shoulder application, the baseplate can be paired with the Univers Revers glenosphere. | |
| For an anatomic shoulder application, the baseplate should be paired with the inlay bearing. The inlay bearing is available in two thicknesses (standards and +2mm) and in sizes corresponding to the glenoid baseplate. Pegs on the underside of the inlay bearing snap into corresponding recesses in the baseplate, ensuring a secure attachment to the bearing inlay, while at the same time minimizing angular rotation. | |
| Indications for Use | The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System. |
| The Arthrex UNIVERS REVERS POROUS 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 |
4
Image /page/4/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 word is an image of a surgical tool, possibly a type of clamp or forceps, also in blue.
| device. | |
|---|---|
| The Arthrex UNIVERS REVERS POROUS 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 POROUS COATED BASEPLATE is porous coated and | |
| is intended for cementless use with the addition of screws for fixation. | |
| The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL | |
| GLENOID INLAY are indicated for use in anatomic joint replacement(s) when | |
| conditions including severe pain or significant disability resulting from | |
| degenerative, rheumatoid, traumatic disease, fracture or injury of the | |
| glenohumeral joint; non-union humeral head fractures of long duration; | |
| avascular necrosis of the humeral head; neoplastic or dysplastic diseases; or | |
| other difficult clinical management problems where arthrodesis or resectional | |
| arthroplasty is not acceptable. | |
| For anatomic joint replacement, the Arthrex UNIVERS REVERS POROUS COATED | |
| BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated to be used with the | |
| humeral components of the Arthrex Univers II Shoulder Prosthesis System for | |
| total shoulder arthroplasty. The UNIVERSAL GLENOID INLAY is intended for use | |
| with the UNIVERS REVERS POROUS COATED BASEPLATE. | |
| Performance Data | Performance testing (shear force, comparative, glenoid dynamic loosening |
| testing and locking mechanism disassembly testing) demonstrated that the | |
| Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID | |
| INLAY 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. | |
| 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. |