(134 days)
No
The document describes a mechanical prosthetic device 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 designed to replace a damaged glenohumeral joint, which directly addresses a medical condition (arthropathy or failed joint replacement) with a therapeutic purpose.
No
Explanation: The document describes a shoulder prosthesis, which is an implant used to replace a damaged joint. Its purpose is therapeutic (to restore function), not diagnostic (to identify a disease or condition).
No
The device description explicitly details physical components made of titanium, UHMWPE, and cobalt chrome, which are hardware implants for a shoulder prosthesis.
No, 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, tissue) to provide information about a person's health.
- Device Description: The provided text describes a shoulder prosthesis, which is an implantable medical device used to replace a damaged shoulder joint. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for replacing a glenohumeral joint in patients with specific conditions. This is a surgical intervention, not a diagnostic test.
The information provided about the device's materials, design, and mechanical testing further confirms it is a physical implant and not an IVD.
N/A
Intended Use / Indications for Use
The Univers Revers Shoulder Prosthesis is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previous failed joint replacement with 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 glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
The uncoated cup and stem are intended for cemented use, all other components are for cementless use only.
Product codes
PHX, KWS
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
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
The submitted mechanical testing data demonstrated that the fatigue strength of the proposed devices is substantially equivalent to the fatigue strength of the predicate devices. The mechanical data indicate that the Univers Revers Shoulder Prosthesis System is adequate for their intended use. Clinical data and conclusions are not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
K053274: Zimmer Anatomical Shoulder System, K100142: Torneir Aequalis Revers Shoulder Prosthesis
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Arthrex. Incorporated Ms. Courtney Smith Regulatory Affairs Manager 1370 Creekside Boulevard Naples, Florida 34108
Re: K130129
Trade/Device Name: Univers 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. KWS Dated: April 29, 2013 Received: May 1, 2013
Dear Ms. Smith:
This letter corrects our substantially equivalent letter of May 31, 2013.
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. Iisting 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
1
Page 2 - Ms. Courtney Smith
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/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
2
1 INDICATIONS FOR USE
Indications for Use
510(k) Number (if known): K130129
Arthrex Univers Revers Shoulder Prosthesis System Device Name:
Indications For Use:
The Univers Revers Shoulder Prosthesis is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previous failed joint replacement with 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 glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
The uncoated cup and stem are intended for cemented use, all other components are for cementless use only.
AND/OR Over-The-Counter Use Prescription Use
(Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
Casey L. Hanley, Ph.D
Division of Orthopedic-Devices
3
K130129 (1/2)
:
MAY 3 1 2013
| 2.2.510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | |
|---|---|
| Date Summary Prepared | January 9, 2013 |
| 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 | Univers Revers Shoulder Prosthesis System |
| Common Name | Shoulder Prosthesis |
| Product Code -Classification Name | KWS - Prosthesis, Shoulder, semi-constrained |
| CFR | metal/polymer, cemented, CFR 888.3660 |
| Predicate Device | K053274: Zimmer Anatomical Shoulder System |
| K100142: Torneir Aequalis Revers Shoulder Prosthesis | |
| Purpose of Submission | This traditional 510(k) premarket notification is |
| submitted to obtain clearance 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 previous failed joint | |
| replacement with 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 glenoid baseplate is CaP coated and is intended for
cementless use with the addition of screws for fixation.
The uncoated cup and stem are intended for cemented
use, all other components are for cementless use only. |
| 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. |
| | The submitted mechanical testing data demonstrated
that the fatigue strength of the proposed devices is
substantially equivalent to the fatigue strength of the
predicate devices. The mechanical data indicate that the
Univers Revers Shoulder Prosthesis System is adequate
for their intended use. 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. |
Y 3 1 201.
:
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K130129 (2/2)
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