Augmented VaultLock Glenoid

K210050 · Arthrex, Inc. · KWS · Jun 7, 2021 · Orthopedic

Device Facts

• Record ID: K210050
• Device Name: Augmented VaultLock Glenoid
• Applicant: Arthrex, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Jun 7, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Augmented VaultLock Glenoid is indicated in replacement(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The glenoid components are designed for cemented fixation in the joint and must only be used with appropriate bone cement.

Device Story

Augmented VaultLock Glenoid is a shoulder prosthesis component; line extension to Arthrex VaultLock Glenoid (K161108). Device features half-wedge augment for glenoid bone loss; spherical articulating surface identical to predicate. Used in shoulder arthroplasty; implanted by orthopedic surgeons in clinical/hospital settings. Requires cemented fixation. Provides structural replacement for damaged glenoid surface; restores joint function; reduces pain. Evaluated via mechanical testing (ASTM F2028) and MRI safety testing.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2028 (Rocking horse testing) to demonstrate performance equivalence. 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 FDA guidance and ASTM F2182.

Technological Characteristics

Material: UHMWPE. Design: Glenoid component with half-wedge augment; 4 nominal sizes. Fixation: Cemented. Standards: ASTM F2028 (mechanical), ASTM F2182 (MRI), ANSI/AAMI ST72:2011/(R)2016 (endotoxin).

Indications for Use

Indicated for patients with severe pain or disability due to degenerative, rheumatoid, or traumatic glenohumeral joint disease/injury, non-union humeral head fractures, irreducible 2- or 4-part proximal humeral fractures, or avascular necrosis of the humeral head, where arthrodesis or resectional arthroplasty is not acceptable.

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

• Arthrex VaultLock Glenoid (K161108)

Reference Devices

• Arthrex Univers Revers Modular Glenoid System (K191960)
• Arthrex Univers II Shoulder Prosthesis (K071032)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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. Ivette Galmez Official Correspondent, Regulatory Affairs 1370 Creekside Boulevard Naples. Florida 34108-1945

Re: K210050

Trade/Device Name: Augmented VaultLock Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: May 21, 2021 Received: May 25, 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

June 7, 2021

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801); medical device 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-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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)

K210050

Device Name

Augmented VaultLock Glenoid

#### Indications for Use (Describe)

The Augmented VaultLock Glenoid is indicated in replacement(s) when conditions include severe pain or significant disability resulting from degenerative, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are designed fixation in the joint and must only be used with appropriate bone cement.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|----------------------------------------------------------|--|
|----------------------------------------------------------|--|

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

| Date Prepared | December 24, 2020 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Ivette Galmez<br>Regulatory Affairs<br>1-239-643-5553, ext. 71263<br>[e-mail] |
| Name of Device | Augmented VaultLock Glenoid |
| Common Name | Shoulder Prosthesis |
| Product Code | KWS |
| Classification Name | 21 CFR 888.3660: Prosthesis, Shoulder, semi-constrained metal/polymer, cemented |
| Regulatory Class | II |
| Predicate Device | K161108: Arthrex VaultLock Glenoid |
| Reference Device | K191960: Arthrex Univers Revers Modular Glenoid System<br>K071032: Arthrex Univers II Shoulder Prosthesis |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for<br>the Augmented VaultLock Glenoid for use with the existing Univers II Shoulder<br>Prosthesis system (K071032). |
| Device Description | The Augmented VaultLock Glenoid is made of the same materials as the predicate<br>(UHMWPE). The Augmented VaultLock Glenoid is designed with a half-wedge<br>augment. The proposed device has an identical spherical articulating surface as that<br>of the previously cleared glenoids and is available in 4 nominal sizes. The proposed<br>device is a line extension to the Arthrex VaultLock Glenoid cleared under K161108. |
| Indications for Use | The Augmented VaultLock Glenoid is indicated in replacement(s) when conditions<br>include severe pain or significant disability resulting from degenerative, rheumatoid,<br>traumatic disease, or injury of the glenohumeral joint; non-union humeral head<br>fractures of long duration; irreducible 2- and 4- part proximal humeral fractures;<br>avascular necrosis of the humeral head; or, other difficult clinical management<br>problems where arthrodesis or resectional arthroplasty is not acceptable.<br>The glenoid components are designed for cemented fixation in the joint and must<br>only be used with appropriate bone cement. |
| Performance Data | Mechanical testing (i.e. Rocking horse testing per ASTM F2028) was performed to<br>demonstrate that the proposed device meets the standards requirements.<br>Bacterial Endotoxin test was conducted in accordance with ANSI/AAMI<br>ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14 to demonstrate that the<br>proposed device meets pyrogen limit specifications.<br>MRI testing was conducted in accordance with FDA guidance Testing and Labeling<br>Medical Devices for Safety in the Magnetic Resonance (MR) Environment and ASTM<br>F2182. |
| Conclusion | The Augmented VaultLock Glenoid is substantially equivalent to the predicate device<br>in which the basic design features and intended use are the same. The mechanical<br>testing data demonstrates that the proposed device performance is equivalent to the<br>predicate device for the desired indications. Any differences between the proposed<br>device and the predicate device are considered minor and do not raise questions<br>regarding safety or effectiveness.<br>Based on the indications for use, technological characteristics, and the summary of<br>data submitted, Arthrex Inc. has determined that the proposed device is substantially<br>equivalent to the currently marketed predicate device. |