K Number
K161782
Device Name
Arthrex Univers Revers Shoulder Prosthesis System
Manufacturer
Date Cleared
2016-11-21

(145 days)

Product Code
Regulation Number
888.3690
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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.
More Information

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)

K130129, K142863

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.

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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 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K161782

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 PreparedNovember 21, 2016
Manufacturer/
Distributor/
SponsorArthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA
510(k) ContactDavid 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 NameArthrex Univers Revers Shoulder Prosthesis System
Common NameShoulder Prosthesis
Product Code,HSD – Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis, CFR
888.3690
Classification Name, CFRPHX - Shoulder joint metal/polymer semi-constrained cemented prosthesis, CFR 888.3660
Predicate DeviceK130129/K142863: Arthrex Univers Revers Shoulder Prosthesis System
Purpose of SubmissionThis 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 DescriptionThe 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 UseThe 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 SummaryThe 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.