(63 days)
The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(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 an appropriate bone cement.
The Arthrex Univers II XL Glenoids are manufactured from UHMWPE. The glenoid articular (lateral) surface is concave and is designed to articulate with the humeral head of the Univers II humeral stems. The fixation (medial) surface is convex and is designed either with a keel or with three pegs for cement interdigitation fixation.
The provided document describes a 510(k) Summary of Safety and Effectiveness for the Arthrex Univers II XL Glenoids. This submission is for a medical device (shoulder prosthesis components) and does not involve an AI/ML powered device. Therefore, many of the requested criteria, which are specific to the evaluation of AI/ML devices, are not applicable.
However, I can extract the information relevant to the device's acceptance criteria and the study that proves it meets them, based on the provided document.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Equivalency Metric/Standard) | Reported Device Performance (Method/Result) |
|---|---|
| Substantial Equivalence to Predicate Devices | Product labeling, intended use, technology, engineering, and performance are the same as previously cleared glenoid devices. |
| Mechanical Performance Standard | ASTM F 2028 mechanical testing data. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a medical device clearance based on substantial equivalence and mechanical testing, not a clinical study involving human data in the context of an AI/ML algorithm. The "test set" and "data provenance" as described in the prompt are relevant to AI/ML model evaluation, not mechanical device testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of expert consensus, is not relevant for mechanical testing of a shoulder prosthesis component.
4. Adjudication Method for the Test Set
Not applicable. No adjudication method is mentioned as this is not a study requiring human readers or interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is not an AI/ML device that assists human readers, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI/ML algorithm. The "standalone performance" here refers to the device's mechanical performance in accordance with industry standards.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the safety and effectiveness of the Arthrex Univers II XL Glenoids relies on:
- Predicate Device Equivalence: The primary "ground truth" is the established safety and effectiveness of the predicate devices (Arthrex Univers II Shoulder System – Pegged Glenoid, K083435; Arthrex Univers Shoulder Prosthesis, K010124). The submission aims to prove the new device is substantially equivalent to these already cleared devices.
- Mechanical Testing Standards: Compliance with industry-recognized mechanical testing standards, specifically ASTM F 2028. This standard serves as the "ground truth" for evaluating the mechanical properties and performance of glenoid components.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/ML algorithm.
Summary of the Study Proving Acceptance Criteria are Met:
The study proving the device meets the acceptance criteria is based on:
- Comparison to Predicate Devices: The submission states that "The product labeling, intended use, and the technology, engineering and performance of Univers XL Glenoids are the same as previously cleared glenoid devices." This forms the primary basis for demonstrating substantial equivalence.
- Mechanical Testing: "The ASTM F 2028 mechanical testing data demonstrated equivalency of the proposed XL glenoids and the predicate device." This testing provides objective evidence that the mechanical properties of the new XL Glenoids are comparable to the previously cleared predicate devices, thus ensuring similar safety and effectiveness in terms of physical performance.
The FDA's decision to clear the device (K120044) is based on the determination that it is "substantially equivalent" to legally marketed predicate devices, taking into account the information provided regarding consistent fundamental features, intended uses, and comparable mechanical performance.
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MAR - 8 2012
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510(k) Summary of Safety and Effectiveness 1
| Date Summary Prepared | January 3, 2012 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Courtney SmithRegulatory Affairs ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1720Fax: 239/598.5508Email: csmith@arthrex.com |
| Trade Name | Arthrex Univers Glenoid |
| Common Name | Shoulder Prosthesis |
| Product Code -ClassificationNameCFR | KWS – Prosthesis, Shoulder, semi constrainedmetal/polymer, cementedHSD – Prosthesis, Shoulder, hemi-humeral, metal,uncemented |
| Predicate Device | Arthrex Univers II Shoulder System – Pegged Glenoid,K083435Arthrex Univers Shoulder Prosthesis, K010124 |
| Purpose of Submission | To obtain clearance of the Arthrex Univers II XLGlenoids (larger glenoid devices) that are a lineextension of the previously cleared predicate small,medium and large glenoids, pegged and keeled. |
| Device Description and IntendedUse | The Arthrex Univers II XL Glenoids are manufacturedfrom UHMWPE. The glenoid articular (lateral) surfaceis concave and is designed to articulate with the humeralhead of the Univers II humeral stems. The fixation(medial) surface is convex and is designed either with akeel or with three pegs for cement interdigitationfixation.The Arthrex XL Univers II Glenoids are indicated inreplacement(s) when conditions include severe pain orsignificant disability resulting from degenerative, |
| rheumatoid, traumatic disease, or injury of theglenohumeral joint; non-union humeral head fractures oflong duration; irreducible 2- and 4- part proximalhumeral fractures; avascular necrosis of the humeralhead; or, other difficult clinical management problemswhere arthrodesis or resectional arthroplasty is notacceptable. | |
| The glenoid components are designed for cementedfixation in the joint and must only be used with anappropriate bone cement. | |
| Substantial EquivalenceSummary | The product labeling, intended use, and the technology,engineering and performance of Univers XL Glenoidsare the same as previously cleared glenoid devices. |
| The ASTM F 2028 mechanical testing datademonstrated equivalency of the proposed XL glenoidsand the predicate device. | |
| The Arthrex Univers II XL Glenoids are substantiallyequivalent to the predicate Arthrex Univers II System –Pegged Glenoids, and the Arthrex Univers ShoulderProsthesis glenoids in which the basic features andintended uses are the same. Any differences betweenthe Arthrex Univers II XL Glenoids and the predicateglenoid devices are considered minor and do not raisequestions concerning safety and effectiveness. Based onthe information submitted, Arthrex, Inc. has determinedthat the larger Arthrex Univers II XL Glenoids aresubstantially equivalent to the currently marketedpredicate devices. |
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K120044
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 8 2012
Arthrex, Incorporated % Ms. Courtney Smith Regulatory Affairs Manager 1370 Creekside Boulevard Naples. Florida 34108-1945
Re: K120044
Trade/Device Name: Arthrex Univers II Glenoid Components Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: February 6, 2012
Received: February 7, 2012
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 for use stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimer that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nece that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merceses, manol of the Act include requirements for annual registration, listing of goneral controls proficious practice, labeling, and prohibitions against misbranding and adulteration.
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 may be sabject to additions, 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 i teaso be devices a determination that your device complies with other requirements of the Act that I Drimas intact and regulations administered by other Federal agencies. You must or any i cacial statutes and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical ci it rail 607), accemberse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Courtney Smith
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 n you dosite specific aarvaboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 Tou inay of Small Manufacturers, International and Consumer Assistance 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 yours,
11
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k): Univers II XL Glenoids, January 4, 2012
Arthrex SPECIAL 510(K): ARTHREX UNIVERS II XL GLENOIDS
Indications for Use Form
Indications for Use
| 510(k) Number: | K223044 |
|---|---|
| ---------------- | --------- |
1
Device Name: Arthrex Univers II Shoulder Prosthesis - XL Glenoids
The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(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 an appropriate bone cement.
Prescription Use V (Per 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(21 CFR 801 Subpart C)
(Division Sign-Off)
PAGE 1 of 1
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120044
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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.”