(157 days)
Not Found
No
The summary describes a shoulder prosthesis and its material composition, with no mention of AI or ML technology.
Yes
The device is a prosthesis indicated for replacement of the shoulder joint due to various conditions, which directly addresses disease or injury to restore function and alleviate symptoms.
No
Explanation: The document describes a shoulder prosthesis, which is an implant used for replacement in cases of joint degeneration, disease, or injury. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a humeral head, which is a physical implantable component of a shoulder prosthesis system. It discusses material composition and mechanical testing, indicating a hardware device.
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 parts of the shoulder joint due to various conditions like degenerative disease, fractures, etc. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details a prosthetic implant (humeral head) made of titanium, designed to be used in a shoulder prosthesis system. This is a physical device implanted during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to replace damaged body parts.
N/A
Intended Use / Indications for Use
The Arthrex UNIVERS II Shoulder Prosthesis is indicated in replacement(s) when conditions including severe pain or significant disability resulting from degenerative, theumatic disease, or injury of the glenohumeral joint; nonunion humeral head fractures of long duration: irreducible 2- and 4-part proximal humeral fractures; of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are intended fixation in the joint and must only be used with appropriate bone cement.
The Arthrex Titanium Humeral Head is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Product codes (comma separated list FDA assigned to the subject device)
KWS
Device Description
The Titanium humeral heads are intended to be used in the Arthrex Univers II Shoulder Prosthesis System. The humeral heads were originally cleared under predicate K071032 as cobalt-chromium (CoCr) devices. The design of the titanium humeral heads is identical to the CoCr heads cleared under predicate K071032. The only difference between the proposed device and the predicate is the material. The titanium humeral heads will provide an alternative to CoCr for use on patients with nickel allergies.
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)
Fatigue testing, pull-off testing, and wear testing were conducted to evaluate the strength and fatigue properties of the proposed titanium humeral heads. Additionally, an engineering analysis was performed to address the substantial equivalence of hardness, adhesion, surface roughness, scratch resistance, young's modulus, and articulating congruency compared to the predicate device. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
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.
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.
Not Found
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
March 8. 2019
Image /page/0/Picture/1 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. David Rogers Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K182799
Trade/Device Name: Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: February 13, 2019 Received: February 14, 2019
Dear David Rogers:
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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 C. Digitally signed by Owens -S -S 14:33:07-05'00'
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K182799
Device Name
Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads
Indications for Use (Describe)
The Arthrex UNIVERS II Shoulder Prosthesis is indicated in replacement(s) when conditions including severe pain or significant disability resulting from degenerative, theumatic disease, or injury of the glenohumeral joint; nonunion humeral head fractures of long duration: irreducible 2- and 4-part proximal humeral fractures; of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are intended fixation in the joint and must only be used with appropriate bone cement.
The Arthrex Titanium Humeral Head is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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 31, 2018 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | David L Rogers |
| Project Manager, Regulatory Affairs | |
| 1-239-643-5553, ext. 71924 | |
| david.rogers@arthrex.com | |
| Name of Device | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads |
| Common Name | Shoulder Prosthesis |
| Product Code | KWS |
| Classification Name | 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented |
| prosthesis | |
| Regulatory Class | II |
| Predicate Device | K140390: Titanium Versa-Dial Humeral Head Prosthesis |
| K140082: Aequalis Ascend Flex Shoulder System | |
| K071032: Arthrex Univers II Shoulder Prosthesis | |
| Purpose of | |
| Submission | This Traditional 510(k) premarket notification is submitted to add a line extension |
| of titanium humeral heads to the Arthrex Univers II shoulder prosthesis system | |
| cleared under K071032. | |
| Device Description | The Titanium humeral heads are intended to be used in the Arthrex Univers II |
| Shoulder Prosthesis System. The humeral heads were originally cleared under | |
| predicate K071032 as cobalt-chromium (CoCr) devices. The design of the | |
| titanium humeral heads is identical to the CoCr heads cleared under predicate | |
| K071032. The only difference between the proposed device and the predicate is | |
| the material. The titanium humeral heads will provide an alternative to CoCr for | |
| use on patients with nickel allergies. | |
| Indications for Use | The Arthrex UNIVERS II Shoulder Prosthesis is indicated in replacement(s) when |
| conditions including 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 intended for cemented fixation in the joint and must | |
| only be used with appropriate bone cement. | |
| The Arthrex Titanium Humeral Head is indicated for patients with suspected | |
| cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are | |
| inferior to that of cobalt alloy. A Titanium humeral head is not recommended for | |
| patients who lack suspected material sensitivity to cobalt alloy. | |
| Performance Data | Fatigue testing, pull-off testing, and wear testing were conducted to evaluate the |
| strength and fatigue properties of the proposed titanium humeral heads. | |
| Additionally, an engineering analysis was performed to address the substantial | |
| equivalence of hardness, adhesion, surface roughness, scratch resistance, | |
| young's modulus, and articulating congruency compared to the predicate device. | |
| Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that | |
| the device meets pyrogen limit specifications. | |
| Conclusion | The Arthrex Univers II Shoulder Prosthesis Titanium Humeral Heads are |
| substantially equivalent to the predicate device in which the basic design features | |
| and intended uses are the same. Any differences between the proposed device | |
| and the predicate device are considered minor and do not raise questions | |
| concerning safety or effectiveness. |
Based on the indications for use, technological characteristics, and the summary
of data submitted, Arthrex Inc. has determined that the Arthrex Univers II
Shoulder Prosthesis Titanium Humeral Heads is substantially equivalent to the
currently marketed predicate device. |
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