(63 days)
Not Found
No
The document describes a mechanical shoulder prosthesis and its components, with no mention of AI or ML technology in its design, function, or intended use.
No
The device is a prosthesis indicated for replacing the glenohumeral joint, which is a structural replacement rather than a therapeutic intervention to treat or cure a disease process.
No
The device description indicates that the Arthrex Univers II Shoulder Prosthesis is a replacement for the glenohumeral joint, designed to articulate with the humeral head of the Univers II humeral stems. It is used to treat conditions like severe pain or disability resulting from disease or injury, and its components are for cemented fixation. These functions describe a prosthetic or implantable device, not a diagnostic one that identifies or characterizes a disease or condition. Its purpose is treatment, not diagnosis.
No
The device description clearly states it is a physical prosthesis manufactured from UHMWPE, designed for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a joint (glenohumeral joint) due to various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and design of a prosthetic joint component, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing information for diagnosis in vitro.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical implant used in vivo to replace a damaged joint.
N/A
Intended Use / Indications for Use
The Arthrex Univers II XL Glenoids are 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 an appropriate bone cement.
Product codes
KWS, HSD
Device Description
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.
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)
The ASTM F 2028 mechanical testing data demonstrated equivalency of the proposed XL glenoids and the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR - 8 2012
Image /page/0/Picture/3 description: The image contains a handwritten alphanumeric string. The string is 'K120044'. The characters are written in a simple, slightly slanted style, with varying stroke thicknesses. The background is plain and white.
510(k) Summary of Safety and Effectiveness 1
| Date Summary Prepared | January 3, 2012 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Regulatory Affairs Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1720 | |
| Fax: 239/598.5508 | |
| Email: csmith@arthrex.com | |
| Trade Name | Arthrex Univers Glenoid |
| Common Name | Shoulder Prosthesis |
| Product Code -Classification | |
| Name | |
| CFR | KWS – Prosthesis, Shoulder, semi constrained |
| metal/polymer, cemented | |
| HSD – Prosthesis, Shoulder, hemi-humeral, metal, | |
| uncemented | |
| Predicate Device | Arthrex Univers II Shoulder System – Pegged Glenoid, |
| K083435 | |
| Arthrex Univers Shoulder Prosthesis, K010124 | |
| Purpose of Submission | To obtain clearance of the Arthrex Univers II XL |
| Glenoids (larger glenoid devices) that are a line | |
| extension of the previously cleared predicate small, | |
| medium and large glenoids, pegged and keeled. | |
| Device Description and Intended | |
| Use | 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 Arthrex XL Univers II Glenoids are 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 an | |
| appropriate bone cement. | |
| Substantial Equivalence | |
| Summary | The product labeling, intended use, and the technology, |
| engineering and performance of Univers XL Glenoids | |
| are the same as previously cleared glenoid devices. | |
| The ASTM F 2028 mechanical testing data | |
| demonstrated equivalency of the proposed XL glenoids | |
| and the predicate device. | |
| The Arthrex Univers II XL Glenoids are substantially | |
| equivalent to the predicate Arthrex Univers II System – | |
| Pegged Glenoids, and the Arthrex Univers Shoulder | |
| Prosthesis glenoids in which the basic features and | |
| intended uses are the same. Any differences between | |
| the Arthrex Univers II XL Glenoids and the predicate | |
| glenoid devices are considered minor and do not raise | |
| questions concerning safety and effectiveness. Based on | |
| the information submitted, Arthrex, Inc. has determined | |
| that the larger Arthrex Univers II XL Glenoids are | |
| substantially equivalent to the currently marketed | |
| predicate devices. |
Page 1 of 2
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K120044
Page 2 of 2
2
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
3
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
4
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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