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.

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.

AI/ML Overview

This document, K142863, is a 510(k) premarket notification for a medical device called the "Universe Revers Shoulder Prosthesis System." It's a submission to include a fracture indication for an existing system. Therefore, the "study" referenced in the document is a comparison to a predicate device that already has the fracture indication, rather than a de novo clinical trial or AI model validation.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance (Implied Equivalence)	Mechanical testing of the Univers Revers Shoulder Prosthesis System was conducted and the results were compared to the Zimmer Anatomical Revers Shoulder System (K053274) and the Tornier Aequalis (referenced in K130129).
Predicate Device Equivalence - Fracture Indication	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."
Material Equivalence	The proposed shoulder devices are substantially equivalent to the predicate devices in regards to its intended use, design, size ranges, and materials.
Design Equivalence	The proposed shoulder devices are substantially equivalent to the predicate devices in regards to its intended use, design, size ranges, and materials.
Intended Use Equivalence	The Univers Revers Shoulder Prosthesis System is substantially equivalent to the predicate devices in which the basic features and intended uses are the same.

2. Sample Size Used for the Test Set and Data Provenance

Test Set: Not applicable in the context of a de novo AI model validation. The "testing" here refers to mechanical testing for the device itself and a comparison to predicate devices, not a test set for an AI algorithm.
Data Provenance: The document does not specify the provenance of the data used for the comparative mechanical testing. It does not mention retrospective or prospective studies in relation to the fracture indication.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This is not an AI algorithm requiring expert ground truth for a test set. The determination of substantial equivalence relies on regulatory review and comparison to already cleared devices and their data.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI algorithm with a test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI device. This is a shoulder prosthesis system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate device (Zimmer Anatomical Revers Shoulder System K053274), which already has the fracture indication. The rationale is that if the proposed device is substantially equivalent to a device already cleared for a fracture indication, then it also meets the criteria. Mechanical testing also serves as evidence of performance for the physical device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI algorithm.

Summary of the Study for K142863:

The "study" that proves the device meets the acceptance criteria for the fracture indication is primarily based on a demonstration of substantial equivalence to a legally marketed predicate device (K053274: Zimmer Anatomical Shoulder System) that already holds the fracture indication, coupled with mechanical testing of the Univers Revers Shoulder Prosthesis System itself to confirm its performance compared to predicate devices.

The key statement is: "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." This indicates a reliance on the previous FDA clearance of a similar device for the targeted indication.

Summary

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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)

K142863

Device Name

Universe Revers Shoulder Prosthesis System

Indications for Use (Describe)

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 NameCFR	PHX - Shoulder joint metal/polymer semi-constrained cementedprosthesis, 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 afracture indication for the Univers Revers Shoulder Prosthesis System
Device Description	The Arthrex Univers Revers Shoulder Prosthesis System has an articulardesign that is inverted compared to traditional total shoulder prosthesis.The system is comprised of two main components; the Arthrex UniversRevers Shoulder Prosthesis and the Universal Glenoid Shoulder Prosthesis.The Arthrex Univers Revers Shoulder Prosthesis is a titanium humeral stemand epiphysis or humeral cup, a titanium spacer, and an UHMWPE humeralcup liner. The humeral stem and epiphysis are available uncoated or withCaP coating. The Universal Glenoid Shoulder Prosthesis consists of aTPS/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 grosslyrotator cuff deficient glenohumeral joint with severe arthropathy or apreviously failed joint replacement with a gross rotator cuff deficiency. Thepatient's joint must be anatomically and structurally suited to receive theselected implant(s), and a functional deltoid muscle is necessary to use thedevice.The Univers Revers Shoulder Prosthesis is indicated for primary, fracture,or revision total shoulder replacement for the relief of pain and significantdisability 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 usewith the addition of screws for fixation.
Substantial Equivalence Summary	The Univers Revers Shoulder Prosthesis System is substantially equivalentto the predicate devices in which the basic features and intended uses arethe same. Any differences between the Univers Revers Shoulder ProsthesisSystem and the predicates are considered minor and do not raise questionsconcerning safety and effectiveness.
	The proposed shoulder devices are substantially equivalent to the predicatedevices in regards to its intended use, design, size ranges, and materials.
	Mechanical testing of the Univers Revers Shoulder Prosthesis System wasconducted and the results of this testing was compared to both the ZimmerAnatomical Revers Shoulder System and the Tornier Aequalis in K130129.No significant changes have been made to the Univers Revers ShoulderProsthesis System, which would affect performance of the device. TheZimmer Anatomical Revers Shoulder System (K053274) is cleared with thefracture indication; therefore no further performance testing is necessaryto add the fracture indication to the Univers Revers Shoulder ProsthesisSystem.
	Additional Performance testing, animal studies and clinical data andconclusions are not needed for this device.
	Based on the indication for use, technological characteristics, and thecomparison to the predicate devices, Arthrex, Inc. has determined that theUnivers Revers Shoulder Prosthesis System is substantially equivalent tocurrently marketed predicate devices.

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Regulation Number and Section

§ 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.”