(55 days)
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No
The document describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a prosthesis intended for total shoulder replacement to relieve pain and disability, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The device description clearly states it is a "Shoulder Prosthesis System," which is an implant used for replacing a joint, not for diagnosing medical conditions. Its intended use is for "relief of pain and significant disability due to gross rotator cuff deficiency" through surgical replacement, not for detection or diagnosis.
No
The device description clearly outlines physical components made of titanium, UHMWPE, and cobalt chrome, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Univers Revers Shoulder Prosthesis System is an implantable device used for surgical replacement of the shoulder joint. It is a physical prosthesis intended to be placed inside the body.
- Lack of IVD Characteristics: There is no mention of testing biological samples, analyzing biomarkers, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
(Humeral) Stems are intended for cemented or cementless applications. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
Product codes (comma separated list FDA assigned to the subject device)
PHX
Device Description
The Arthrex Univers Revers Shoulder Prosthesis System has an articular design that is inverted compared to traditional total shoulder prosthesis. The system is comprised of two main components; the Arthrex Univers Revers Shoulder Prosthesis and the Universal Glenoid Shoulder Prosthesis. The Arthrex Univers Revers Shoulder Prosthesis is a titanium humeral stem and epiphysis or humeral cup, a titanium spacer, and an UHMWPE humeral cup liner. The humeral stem and epiphysis are available uncoated or with CaP coating. The Universal Glenoid Shoulder Prosthesis consists of a TPS/CaP coated titanium glenoid baseplate, a cobalt chrome glenosphere, and titanium screws.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Glenohumeral joint (Shoulder)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of the Univers Revers Shoulder Prosthesis System was conducted and the results of this testing was compared to both the Zimmer Anatomical Revers Shoulder System and the Tornier Aequalis in K130129. No significant changes have been made to the Univers Revers Shoulder Prosthesis System, which would affect performance of the device. The Zimmer Anatomical Revers Shoulder System (K053274) is cleared with the fracture indication; therefore no further performance testing is necessary to add the fracture indication to the Univers Revers Shoulder Prosthesis System.
Additional Performance testing, animal studies and clinical data and conclusions are not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, and they are the most prominent element of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2014
Arthrex, Incorporated Ms. Courtney Smith Regulatory Affairs Manager 1370 Creekside Boulevard Naples, Florida 34108
Re: K142863
Trade/Device Name: Universe Revers Shoulder Prosthesis System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: September 30, 2014 Received: October 1, 2014
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 Part 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/Resourcesfor You/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 yours, Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.3 INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Universe Revers Shoulder Prosthesis System
Indications for Use (Describe)
The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
(Humeral) Stems are intended for cemented or cementless applications. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | November 24, 2014 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc |
| 1370 Creekside Blvd. | |
| Naples, FL | |
| 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 | Univers Revers Shoulder Prosthesis System |
| Common Name | Shoulder Prosthesis |
| Product Code - Classification Name | |
| CFR | PHX - Shoulder joint metal/polymer semi-constrained cemented |
| prosthesis, CFR 888.3660 | |
| Predicate Device | K053274: Zimmer Anatomical Shoulder System |
| K130129: Arthrex Univers Revers Prosthesis Shoulder System | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to include a |
| fracture indication for the Univers Revers Shoulder Prosthesis System | |
| Device Description | The Arthrex Univers Revers Shoulder Prosthesis System has an articular |
| design that is inverted compared to traditional total shoulder prosthesis. | |
| The system is comprised of two main components; the Arthrex Univers | |
| Revers Shoulder Prosthesis and the Universal Glenoid Shoulder Prosthesis. | |
| The Arthrex Univers Revers Shoulder Prosthesis is a titanium humeral stem | |
| and epiphysis or humeral cup, a titanium spacer, and an UHMWPE humeral | |
| cup liner. The humeral stem and epiphysis are available uncoated or with | |
| CaP coating. The Universal Glenoid Shoulder Prosthesis consists of a | |
| TPS/CaP coated titanium glenoid baseplate, a cobalt chrome glenosphere, | |
| and titanium screws. | |
| Intended Use | The Univers Revers Shoulder Prosthesis is indicated for use in a grossly |
| rotator cuff deficient glenohumeral joint with severe arthropathy or a | |
| previously failed joint replacement with a gross rotator cuff deficiency. The | |
| patient's joint must be anatomically and structurally suited to receive the | |
| selected implant(s), and a functional deltoid muscle is necessary to use the | |
| device. | |
| The Univers Revers Shoulder Prosthesis is indicated for primary, fracture, | |
| or revision total shoulder replacement for the relief of pain and significant | |
| disability due to gross rotator cuff deficiency. | |
| (Humeral) Stems are intended for cemented or cementless applications. | |
| The glenoid baseplate is CaP coated and is intended for cementless use | |
| with the addition of screws for fixation. | |
| Substantial Equivalence Summary | The Univers Revers Shoulder Prosthesis System is substantially equivalent |
| to the predicate devices in which the basic features and intended uses are | |
| the same. Any differences between the Univers Revers Shoulder Prosthesis | |
| System and the predicates are considered minor and do not raise questions | |
| concerning safety and effectiveness. | |
| The proposed shoulder devices are substantially equivalent to the predicate | |
| devices in regards to its intended use, design, size ranges, and materials. | |
| Mechanical testing of the Univers Revers Shoulder Prosthesis System was | |
| conducted and the results of this testing was compared to both the Zimmer | |
| Anatomical Revers Shoulder System and the Tornier Aequalis in K130129. | |
| No significant changes have been made to the Univers Revers Shoulder | |
| Prosthesis System, which would affect performance of the device. The | |
| Zimmer Anatomical Revers Shoulder System (K053274) is cleared with the | |
| fracture indication; therefore no further performance testing is necessary | |
| to add the fracture indication to the Univers Revers Shoulder Prosthesis | |
| System. | |
| Additional Performance testing, animal studies and clinical data and | |
| conclusions are not needed for this device. | |
| Based on the indication for use, technological characteristics, and the | |
| comparison to the predicate devices, Arthrex, Inc. has determined that the | |
| Univers Revers Shoulder Prosthesis System is substantially equivalent to | |
| currently marketed predicate devices. |
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