(150 days)
No
The summary describes a mechanical implant (glenoid component) and its materials, design features (half-wedge augment), and mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is indicated for replacement in conditions causing severe pain or significant disability due to degenerative or traumatic disease, injury, fractures, or avascular necrosis of the glenohumeral joint, which aims to treat or alleviate a disease, injury, or condition.
No
Explanation: The device is an Augmented VaultLock Glenoid, which is an implant used for replacement in painful or disabled glenohumeral joints. Its purpose is therapeutic (replacement of damaged joints), not diagnostic. The documentation describes its materials, design, and testing for safety and performance as an implant.
No
The device description clearly states it is a physical implant made of UHMWPE, designed for surgical implantation in the glenohumeral joint. It also mentions mechanical testing and bacterial endotoxin testing, which are relevant to physical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for replacing the glenohumeral joint due to various conditions. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical implant made of UHMWPE, designed for surgical fixation. This is consistent with a medical device used in surgery, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
- Performance Studies: The performance studies focus on mechanical testing, bacterial endotoxin testing, and MRI compatibility, which are typical for surgical implants, not IVDs.
In summary, the Augmented VaultLock Glenoid is a surgical implant used for joint replacement, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KWS
Device Description
The Augmented VaultLock Glenoid is made of the same materials as the predicate (UHMWPE). The Augmented VaultLock Glenoid is designed with a half-wedge augment. The proposed device has an identical spherical articulating surface as that of the previously cleared glenoids and is available in 4 nominal sizes. The proposed device is a line extension to the Arthrex VaultLock Glenoid cleared under K161108.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing (i.e. Rocking horse testing per ASTM F2028) was performed to demonstrate that the proposed device meets the standards requirements.
Bacterial Endotoxin test was conducted in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14 to demonstrate that the proposed device meets pyrogen limit specifications.
MRI testing was conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment and ASTM F2182.
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.
K161108: Arthrex VaultLock Glenoid
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.
K191960: Arthrex Univers Revers Modular Glenoid System, K071032: Arthrex Univers II Shoulder Prosthesis
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
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known)
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 ( 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
| Date Prepared | December 24, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Ivette Galmez |
| Regulatory Affairs | |
| 1-239-643-5553, ext. 71263 | |
| Ivette.galmez@arthrex.com | |
| 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 |
| K071032: Arthrex Univers II Shoulder Prosthesis | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Augmented VaultLock Glenoid for use with the existing Univers II Shoulder | |
| Prosthesis system (K071032). | |
| Device Description | The Augmented VaultLock Glenoid is made of the same materials as the predicate |
| (UHMWPE). The Augmented VaultLock Glenoid is designed with a half-wedge | |
| augment. The proposed device has an identical spherical articulating surface as that | |
| of the previously cleared glenoids and is available in 4 nominal sizes. The proposed | |
| 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 |
| 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. | |
| Performance Data | Mechanical testing (i.e. Rocking horse testing per ASTM F2028) was performed to |
| demonstrate that the proposed device meets the standards requirements. | |
| Bacterial Endotoxin test was conducted in accordance with ANSI/AAMI | |
| ST72:2011/(R)2016, USP , USP , EP 2.6.14 to demonstrate that the | |
| proposed device meets pyrogen limit specifications. | |
| MRI testing was conducted in accordance with FDA guidance Testing and Labeling | |
| Medical Devices for Safety in the Magnetic Resonance (MR) Environment and ASTM | |
| F2182. | |
| Conclusion | The Augmented VaultLock Glenoid is substantially equivalent to the predicate device |
| in which the basic design features and intended use are the same. The mechanical | |
| testing data demonstrates that the proposed device performance is equivalent to the | |
| predicate device for the desired indications. Any differences between the proposed | |
| device and the predicate device are considered minor and do not raise questions | |
| regarding 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. |