(131 days)
The Arthrex VaultLock Glenoid is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatic 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 an appropriate bone cement.
The Arthrex VaultLock Glenoid is a UHMWPE glenoid designed to be used with the existing Univers II Shoulder Prosthesis system (K071032). The proposed Arthrex VaultLock Glenoid has an identical spherical articulating surface as that of the previously cleared glenoids and is available in 4 nominal sizes.
This document is a 510(k) Pre-Market Notification for the Arthrex VaultLock Glenoid, a medical device. This document describes a medical device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable here.
The document contains information about the device's performance testing, which serves a similar role to "acceptance criteria" but in the context of device equivalence rather than AI/ML model performance.
Here's the relevant information extracted from the document regarding the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test / Acceptance Criteria | Reported Device Performance |
|---|---|
| Bacterial Endotoxin Testing | Performed per EP 2.6.14/USP <85> |
| Rocking Horse Stability | Preclinical testing performed per ASTM F2028 |
Explanation of Performance:
- Bacterial Endotoxin Testing: This test ensures that the device is free from harmful levels of bacterial endotoxins, which are a safety concern for implanted devices. The performance indicates that the device met the standards specified in European Pharmacopoeia (EP 2.6.14) and United States Pharmacopeia (USP <85>).
- Rocking Horse Stability: This test, performed according to ASTM F2028, assesses the mechanical stability of the glenoid component within the joint under simulated loading conditions. This is crucial for evaluating its long-term performance and resistance to loosening once implanted.
2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device, not an AI/ML diagnostic system. The "test set" here refers to physical devices undergoing testing, not a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert consensus are concepts typically applied to AI/ML model evaluation of data, not to the physical testing of a medical implant. The design and testing standards (e.g., ASTM) are established by groups of experts in biomaterials and orthopedics, but this is a different context.
4. Adjudication method for the test set: Not applicable as this is a physical device testing, not an AI/ML evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document pertains to a physical shoulder prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a physical device. For device performance, the "ground truth" is defined by the objective physical and chemical properties measured against established standards (e.g., freedom from endotoxins, mechanical stability under load).
8. The sample size for the training set: Not applicable. There is no AI/ML training set mentioned.
9. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set mentioned.
Summary of Device Equivalence:
The document concludes that the Arthrex VaultLock Glenoid is "substantially equivalent to the predicate devices in which the basic design features and intended uses are the same. Any differences between the Arthrex VaultLock Glenoid and the predicates are considered minor and do not raise questions concerning safety and effectiveness." This substantial equivalence is based on the device's design, intended use, and the successful completion of the described performance tests.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2016
Arthrex, Incorporated Courtney Smith Manager. Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K161108
Trade/Device Name: Arthrex 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: August 8, 2016 Received: August 9, 2016
Dear Ms. 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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Arthrex. SPECIAL 510(K): ARTHREX VALUTLOCK GLENOID
2.5 INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161108
Device Name Arthrex VaultLock Glenoid
Indications for Use (Describe)
The Arthrex VaultLock Glenoid is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatic 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 an 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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FORM FDA 3881 (8/14)
150 1100000000 STATIOS (101) 443-634
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Image /page/3/Picture/1 description: The image shows the Arthrex logo followed by the text "SPECIAL 510(K): ARTHREX VALUTLOCK GLENOID". The Arthrex logo is a stylized text with a graphic element. The text is in black and appears to be a title or heading for a document or presentation. The text indicates that the document is related to a special 510(k) submission for the Arthrex Valutlock Glenoid product.
510K SUMMARY OF SAFETY AND EFFECTIVENESS 1.1
| Date SummaryPrepared | August 22, 2016 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Manager, Regulatory Affairs | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext.71720 | |
| Fax: 239/598.5508 | |
| Email: Courtney.Smith@Arthrex.com | |
| Trade Name | Arthrex VaultLock Glenoid |
| Common Name | Shoulder Prosthesis |
| Product Code,ClassificationName, CFR | KWS - Prosthesis, Shoulder, semi-constrained metal/polymer,cemented, CFR 888.3660 |
| Predicate Device | Primary Predicate |
| Arthrex Univers II Shoulder System - Pegged Glenoid, K083435 | |
| Reference Predicate | |
| Arthrex Univers II XL Pegged Glenoids - K120044 | |
| Purpose ofSubmission | This special 510(k) premarket notification is submitted to obtainclearance for the Arthrex VaultLock Glenoid |
| Device Description | The Arthrex VaultLock Glenoid is a UHMWPE glenoid designedto be used with the existing Univers II Shoulder Prosthesissystem (K071032). The proposed Arthrex VaultLock Glenoid hasan identical spherical articulating surface as that of thepreviously cleared glenoids and is available in 4 nominal sizes. |
| Intended Use | The Arthrex VaultLock Glenoid is indicated in replacements(s)when conditions include severe pain or significant disability |
| resulting from degenerative, rheumatoid, traumatic disease, orinjury of the glenohumeral joint; non-union humeral headfractures of long duration; irreducible 2- and 4- part proximalhumeral fractures; avascular necrosis of the humeral head; or,other difficult clinical management problems where arthrodesisor resectional arthroplasty is not acceptable. | |
| The glenoid components are designed for cemented fixation inthe joint and must only be used with appropriate bone cement. | |
| Performance | • Bacterial endotoxin testing per EP 2.6.14/USP <85>. |
| • Preclinical testing performed per ASTM F2028 (Rocking horsestability). | |
| Conclusion | The Arthrex VaultLock Glenoid is substantially equivalent to thepredicate devices in which the basic design features andintended uses are the same. Any differences between theArthrex VaultLock Glenoid and the predicates are consideredminor and do not raise questions concerning safety andeffectiveness. |
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§ 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.”