Univers Revers Modular Glenoid System, Standard Augment Baseplates

K211074 · Arthrex, Inc. · PHX · Sep 2, 2021 · Orthopedic

Device Facts

• Record ID: K211074
• Device Name: Univers Revers Modular Glenoid System, Standard Augment Baseplates
• Applicant: Arthrex, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Sep 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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 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 Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.

Device Story

Modular glenoid system for total shoulder arthroplasty; consists of titanium baseplates with BioSync porous coating; used in cementless fixation with peripheral screws. Designed for patients with severe rotator cuff deficiency and functional deltoid muscle. Implanted by orthopedic surgeons in clinical/hospital settings. Provides mechanical stability for glenohumeral joint; relieves pain and disability associated with arthropathy or failed prior replacements. Subject device represents line extension of existing system, featuring modified screw hole configurations relative to augments.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2028 (Rocking horse testing). Bacterial endotoxin testing performed per ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, and EP 2.6.14. MRI safety testing conducted per ASTM F2182 and FDA guidance.

Technological Characteristics

Titanium baseplates with BioSync porous coating; sizes 24 and 28; full and half augments. Cementless fixation via peripheral screws. Mechanical testing per ASTM F2028. Bacterial endotoxin testing per ANSI/AAMI ST72:2011/(R)2016. MRI safety per ASTM F2182.

Indications for Use

Indicated for patients with grossly rotator cuff deficient glenohumeral joint, severe arthropathy, or failed joint replacement with gross rotator cuff deficiency. Requires anatomically/structurally suited joint and functional deltoid muscle. Used for primary, fracture, or revision total shoulder replacement.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Univers Revers Modular Glenoid System, Augmented baseplates (K193372)

Reference Devices

• Univers Revers Modular Glenoid System, Half Augment Baseplate (K200895)
• Arthrex Univers Revers Modular Glenoid System (K173900)
• Arthrex Univers Revers Modular Glenoid System (K191960)

Submission Summary (Full Text)

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September 2, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Arthrex Inc. Ivette Galmez Regulatory Affairs Principal Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K211074

Trade/Device Name: Univers Revers Modular Glenoid System, Standard Augment Baseplates Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: April 9, 2021 Received: April 12, 2021

Dear Ivette Galmez:

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

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device reporting (reporting of medical device-related adverse events) (21 CFR 803) for 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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Michael Owens Assistant 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) K211074

#### Device Name

Univers Revers Modular Glenoid System, Standard Augment Baseplates

#### Indications for Use (Describe)

The 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 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 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*)

| <span style="font-size:120%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:120%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

| Date Prepared | July 27, 2021 |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc. |
| | 1370 Creekside Boulevard |
| | Naples, FL 34108-1945 |
| Contact Person | Ivette Galmez |
| | Regulatory Affairs Specialist, Principal |
| | 1-239-643-5553, ext. 71263 |
| | [e-mail] |
| Name of Device | Univers Revers Modular Glenoid System, Standard Augment Baseplates |
| Common Name | Shoulder Prosthesis |
| Product Code | PHX |
| Classification Name | 21 CFR 888.3660: Shoulder joint metal polymer semi constrained cemented prosthesis |
| Regulatory Class | II |
| Predicate Device | K193372: Univers Revers Modular Glenoid System, Augmented baseplates |
| Reference Device | K200895: Univers Revers Modular Glenoid System, Half Augment Baseplate |
| | K173900: Arthrex Univers Revers Modular Glenoid System |
| | K191960: Arthrex Univers Revers Modular Glenoid System |
| Purpose of<br>Submission | This 510(k) premarket notification is submitted to obtain clearance for additional augmented<br>baseplates as a line extension to the Arthrex Univers Revers Modular Glenoid System cleared<br>under K173900, K193372 and K191960. |
| Device Description | The subject devices are augmented baseplates made of titanium with BioSync coating. The<br>baseplates are available in sizes 24 and 28 with full and half augments. The subject devices are<br>designed to be used cementless with peripheral screws and glenosphere devices cleared under<br>K193372, K191960 and K173900. |
| Indications for Use | The Univers Revers Modular Glenoid System is indicated for use in a grossly rotator cuff deficient<br>glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross<br>rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive<br>the selected implant(s), and a functional deltoid muscle is necessary to use the device.<br><br>The Univers Revers Modular Glenoid System is indicated for primary, fracture, or revision total<br>shoulder replacement for the relief of pain and significant disability due to gross rotator cuff<br>deficiency.<br><br>The Univers Revers Modular Glenoid System is porous coated and is intended for cementless use<br>with the addition of screws for fixation. |
| Summary of<br>Technological<br>Characteristics | The subject devices are made of the same materials as the predicate. The subject devices have<br>the same intended use/indications, packaging, shelf life and sterilization as the predicate. The<br>subject baseplates are offered in the same sizes as previously cleared Arthrex augmented<br>baseplates. The difference with the predicate is the screw hole configuration with respect to the<br>augment. |
| Performance Data | Mechanical testing (i.e. Rocking horse testing per ASTM F2028) was performed to demonstrate<br>that the subject device meets the standards requirements.<br><br>Bacterial Endotoxin test was conducted in accordance with ANSI/AAMI ST72:2011/(R)2016, USP<br><161>, USP <85>, EP 2.6.14 to demonstrate that the subject device meets pyrogen limit<br>specifications.<br><br>MRI testing were conducted in accordance with FDA guidance Testing and Labeling Medical<br>Devices for Safety in the Magnetic Resonance (MR) Environment and ASTM F2182. |
| Conclusion | The subject devices are substantially equivalent to the predicate device in which the basic design<br>features and intended use are the same. The mechanical testing data demonstrates that the<br>subject device performance is equivalent to the predicate device for the desired indications. Any<br>differences between the subject device and the predicate device are considered minor and do not<br>raise questions regarding safety or effectiveness.<br><br>Based on the indications for use, technological characteristics, and the summary of data<br>submitted, Arthrex Inc. has determined that the subject device is substantially equivalent to the<br>currently marketed predicate device. |