The Arthrex UNIVERS REVERS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System.

The Arthrex UNIVERS REVERS COATED BASEPLATE 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 suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The Arthrex UNIVERS REVERS COATED BASEPLATE is coated and is intended for cementless use with the addition of screws for fixation.

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 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 cementless applications for use with the Arthrex Humeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex Univers Revers CA Heads and Adapters are indicated for salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed humeral stem, to an anatomic hemi-shoulder replacement; or conversion of a primary reverse total shoulder. for the relief of pain secondary to severe rotator and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has been implanted.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device

The Arthrex Univers Shoulder Fracture Prosthesis is indicated for severe pain or significant disability resulting from degenerative, theumatoid, or traumatic disease or injury of the glenohumeral joint. This included traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures. comminuted fracture, humeral head fracture, displaced 3-or4-fragment proximal head fractures, of the humeral head, and fractures of the anatomical neck.

The Arthrex Univers Shoulder Fracture Prosthesis is designed for cemented use. This device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.

The Arthrex UNIVERS II and UNIVERS APEX Shoulder Prosthesis is indicated in replacement(s) when conditions including severe pain or significant disability resulting from degenerative, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are intended fixation in the joint and must only be used with appropriate bone cement.

Device Description

The Arthrex Shoulder Systems encompass the following FDA cleared devices:
• Arthrex Univers II Should Prosthesis
• Arthrex Univers Apex
• Arthrex Univers Revers Shoulder Prosthesis System
These systems are comprised of humeral and glenoid components for use in shoulder prosthesis.

AI/ML Overview

This document is a 510(k) premarket notification for the Arthrex Shoulder System, seeking clearance for a modification to the device labeling to include an "MR Conditional" statement. It does not contain information about a study proving the device meets acceptance criteria related to clinical performance or an AI/algorithmic medical device.

Therefore, I cannot provide details on:

A table of acceptance criteria and reported device performance.
Sample size and data provenance for a test set.
Number and qualifications of experts for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study or its effect size.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence for an existing device with a labeling change for MR compatibility. The "Performance Data" section specifically mentions non-clinical testing and in-vivo electromagnetic simulation to demonstrate MR Conditional status and bacterial endotoxin testing. This is not the type of clinical performance study typically described by the detailed questions you've posed, which are more relevant to the validation of AI/ML-based medical devices or new device types requiring clinical efficacy studies.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Food and Drug Administration (FDA) and the Department of Health & Human Services. The FDA logo features the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure.

March 29, 2018

Arthrex Inc. David Rogers Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K171841

Trade/Device Name: Arthrex Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD, PHX Dated: February 26, 2018 Received: March 1, 2018

Dear Mr. 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 of medical 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.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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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Indications for Use

510(k) Number (if known) K171841

Device Name

Arthrex UNIVERS REVERS COATED BASEPLATE

Indications for Use (Describe)

The Arthrex UNIVERS REVERS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System.

The Arthrex UNIVERS REVERS COATED BASEPLATE is 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K171841

Device Name

Arthrex Univers Revers Shoulder Prosthesis System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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Indications for Use

510(k) Number (if known) K171841

Device Name

Arthrex Univers Revers CA Heads and Adapters

Indications for Use (Describe)

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{5}------------------------------------------------

Indications for Use

510(k) Number (if known) K171841

Device Name

Arthrex Univers Shoulder Fracture Prosthesis

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{6}------------------------------------------------

Indications for Use

510(k) Number (if known) K171841

Device Name

Arthrex UNIVERS II and UNIVERS APEX Shoulder Prosthesis

Indications for Use (Describe)

The glenoid components are intended fixation in the joint and must only be used with appropriate bone cement.

| Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Summary or 510(k) Statement

Date Prepared	March 28, 2017
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	David L RogersProject Manager, Regulatory Affairs1-239-643-5553, ext. 71924david.rogers@arthrex.com
Name of Device	Arthrex Shoulder Systems
Common Name	Shoulder Prosthesis
Product Code	KWS, HSD, PHX
Classification Name	21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cementedprosthesis21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) metallic uncementedprosthesis
Regulatory Class	II
Predicate Device	K020345: Arthrex Univers Shoulder Fracture ProsthesisK071032: Arthrex Univers II Shoulder ProsthesisK083435: Arthrex Univers II Pegged GlenoidK103466: Arthrex Univers II #5 StemK120044: Arthrex Univers II Shoulder Prosthesis – XL GlenoidsK130129: Arthrex Univers ReversK130675: Arthrex Univers CA HeadsK131633: Arthrex Univers ApexK142863: Arthrex Univers Revers FractureK151527: Arthrex Univers Revers CA HeadsK153115: Arthrex Univers Apex Size 5 StemK161108: Arthrex VaultLock GlenoidK161782: Arthrex Univers Revers Shoulder Prosthesis SystemK173271: Arthrex Revers Coated Baseplate
Purpose ofSubmission	This Traditional 510(k) premarket notification is submitted to obtain clearance forthe modification to the device labeling for the Arthrex Shoulder Systems toinclude the "MR Conditional" statement in accordance with the FDA Guidance,"Establishing Safety and Compatibility of Passive Implants in the MagneticResonance (MR) Environment".
Device Description	The Arthrex Shoulder Systems encompass the following FDA cleared devices:• Arthrex Univers II Should Prosthesis• Arthrex Univers Apex• Arthrex Univers Revers Shoulder Prosthesis SystemThese systems are comprised of humeral and glenoid components for use inshoulder prosthesis.
Indications for Use	The Arthrex Univers Shoulder Fracture Prosthesis is indicated for severe pain orsignificant disability resulting from degenerative, rheumatoid, or traumaticdisease or injury of the glenohumeral joint. This included traumatic orpathological conditions of the shoulder resulting in fracture of the glenohumeraljoint, including impression fractures, comminuted fracture, humeral headfracture, displaced 3 or4-fragment proximal head fractures avascular necrosis of

{8}------------------------------------------------

the humeral head, and fractures of the anatomical neck.

The Arthrex Univers Shoulder Fracture Prosthesis is designed for cemented or non-cemented use. This device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.

The Arthrex UNIVERS II and UNIVERS APEX Shoulder Prosthesis is indicated in replacement(s) when conditions including severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.

(Humeral) Stems are intended for cemented or cementless applications for use with the Arthrex Humeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex Univers Revers CA Heads and Adapters are indicated for

salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed humeral stem, to an anatomic hemi-shoulder replacement; or
conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has been implanted.

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 Arthrex UNIVERS REVERS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System.

The Arthrex UNIVERS REVERS COATED BASEPLATE 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.

{9}------------------------------------------------

	The Arthrex UNIVERS REVERS COATED BASEPLATE is indicated for primary,fracture, or revision total shoulder replacement for the relief of pain andsignificant disability due to gross rotator cuff deficiency.The Arthrex UNIVERS REVERS COATED BASEPLATE is coated and is intended forcementless use with the addition of screws for fixation.
Performance Data	Non-clinical testing and in-vivo electromagnetic simulation per the FDA Guidance,"Establishing Safety and Compatibility of Passive Implants in the MagneticResonance (MR) Environment", demonstrated that the Arthrex Shoulder Systemsare "MR Conditional".Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications.
Conclusion	The Arthrex Shoulder Systems are substantially equivalent to the predicatedevice in which the basic design features and intended uses are the same. Anydifferences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness.Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate device.

The Arthrex UNIVERS REVERS COATED BASEPLATE is indicated for primary,fracture, or revision total shoulder replacement for the relief of pain andsignificant disability due to gross rotator cuff deficiency.The Arthrex UNIVERS REVERS COATED BASEPLATE is coated and is intended forcementless use with the addition of screws for fixation.

Performance Data

Non-clinical testing and in-vivo electromagnetic simulation per the FDA Guidance,"Establishing Safety and Compatibility of Passive Implants in the MagneticResonance (MR) Environment", demonstrated that the Arthrex Shoulder Systemsare "MR Conditional".Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications.

Conclusion

The Arthrex Shoulder Systems are substantially equivalent to the predicatedevice in which the basic design features and intended uses are the same. Anydifferences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness.Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate device.

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.”