(145 days)
Not Found
No
The summary describes a mechanical shoulder prosthesis system and does not mention any AI or ML components.
Yes.
The device is indicated for the relief of pain and significant disability, which aligns with the definition of a therapeutic device.
No
Explanation: The device description and intended use clearly state that this is a shoulder prosthesis system designed for joint replacement, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly describes physical implants (humeral stems and suture cups) which are hardware components, 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 used to replace a damaged shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a shoulder prosthesis (stems, cups, baseplate), which are physical implants.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information.
- Performance Studies: The performance studies focus on the mechanical properties of the implant (fatigue, abrasion), which are relevant to its function as a surgical device.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device does not fit that description.
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 rotator cuff deficiency.
(Humeral) Stems are intended for cementless applications for use with Arthrex Humeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
Product codes
HSD, PHX
Device Description
The Arthrex Univers Revers Humeral Stems and Suture Cups is a line extension to the Arthrex Univers Revers Shoulder Prosthesis System. The proposed humeral stems, sizes 6 thru 15, are modified versions of the humeral stems cleared under K130129/K142863 and are designed to be shorter in medial to lateral width. The line extension also introduces a size 5 modular stem as well as modified versions of the Humeral Suture Cups.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint / 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
Dynamic fatigue testing was performed to evaluate the fatigue resilience of the proposed Univers Revers Humeral Stems and Humeral Suture Cups. All constructs survived 10 million cycles for both compression and torsion loading conditions. Abrasion testing was also performed to assess the risk of suture abrasion using the new Humeral Suture Cups. Abrasion resistance exceeded the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2016
Arthrex, Inc. David L. Rogers Project Manager, Regulatory Affairs 1370 Creekside Blvd. Naples, Florida 34108-1945
Re: K161782
Trade/Device Name: Arthrex Univers Revers Shoulder Prosthesis System Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD, PHX Dated: October 19, 2016 Received: October 20, 2016
Dear David L. 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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" (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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Arthrex Univers 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 rotator cuff deficiency.
(Humeral) Stems are intended for cementless applications for use with Arthrex Humeral Suture Cups. 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)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510K SUMMARY OF SAFETY AND EFFECTIVENESS
Date Summary Prepared | November 21, 2016 |
---|---|
Manufacturer/ | |
Distributor/ | |
Sponsor | Arthrex, Inc. |
1370 Creekside Boulevard | |
Naples, FL 34108-1945 USA | |
510(k) Contact | David L Rogers |
Project Manager, Regulatory Affairs | |
Arthrex, Inc. | |
1370 Creekside Boulevard | |
Naples, FL 34108-1945 USA | |
Telephone: 239/643.5553, ext. 71924 | |
Fax: 239/598.5508 | |
Email: david.rogers@arthrex.com | |
Trade Name | Arthrex Univers Revers Shoulder Prosthesis System |
Common Name | Shoulder Prosthesis |
Product Code, | HSD – Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis, CFR |
888.3690 | |
Classification Name, CFR | PHX - Shoulder joint metal/polymer semi-constrained cemented prosthesis, CFR 888.3660 |
Predicate Device | K130129/K142863: Arthrex Univers Revers Shoulder Prosthesis System |
Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for the |
Arthrex Univers Revers Humeral Stems and Suture Cups as a line extension to the Arthrex | |
Univers Revers Shoulder Prosthesis System. | |
Device Description | The Arthrex Univers Revers Humeral Stems and Suture Cups is a line extension to the |
Arthrex Univers Revers Shoulder Prosthesis System. The proposed humeral stems, sizes 6 | |
thru 15, are modified versions of the humeral stems cleared under K130129/K142863 and | |
are designed to be shorter in medial to lateral width. The line extension also introduces a | |
size 5 modular stem as well as modified versions of the Humeral Suture Cups. | |
Intended 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 rotator cuff | |
deficiency. | |
(Humeral) Stems are intended for cemented or cementless applications for use with Arthrex | |
Humeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless | |
use with the addition of screws for fixation. | |
Substantial | |
Equivalence Summary | The Arthrex Univers Revers Humeral Stems and Suture Cups are substantially equivalent to |
the predicate devices, in which the fundamental scientific technology and intended use are | |
the same. Any differences between the Arthrex Univers Revers Humeral Stems and Suture | |
Cups and the predicate are considered minor and do not raise questions concerning safety | |
and effectiveness. | |
Dynamic fatigue testing was performed to evaluate the fatigue resilience of the proposed | |
Univers Revers Humeral Stems and Humeral Suture Cups. All constructs survived 10 million | |
cycles for both compression and torsion loading conditions. Abrasion testing was also | |
performed to assess the risk of suture abrasion using the new Humeral Suture Cups. | |
Abrasion resistance exceeded the predicate. | |
Based on the indication for use, technological characteristics, and the summary of data | |
submitted, Arthrex, Inc. has determined that the Arthrex Univers Revers Shoulder Prosthesis | |
System is substantially equivalent to currently marketed predicate device. |