The Univers Revers Shoulder Prosthesis System is 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 SutureCups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

Device Description

This Traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex Univers Revers Monoblock Stem Size 4/33 as a line extension to the Arthrex Univers Revers Humeral Stems cleared under K130129 for use in the Arthrex Univers Revers Shoulder Prosthesis System.
The Arthrex Univers Revers Monoblock Stem Size 4/33 is a humeral stem that is manufactured from Titanium (Ti-AL-4V), coated with either Calcium Phosphate (CaP) or Hydroxyapatite (HA), and offered sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Arthrex Univers Revers Monoblock Stem Size 4/33. This notification aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study or AI performance evaluation.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating AI/ML-based medical devices or studies proving clinical efficacy against defined endpoints, are not applicable to this 510(k) submission.

This submission focuses on demonstrating that the new device, a line extension, is technologically equivalent to its predicate. The "Performance Data" section describes engineering tests to assess the device's physical properties and safety, not a study evaluating performance against acceptance criteria in the context of diagnostic accuracy or clinical outcomes.

Here's a breakdown of why the requested information is not present:

Acceptance Criteria and Reported Device Performance (Table): Not applicable. The submission is for substantial equivalence, not for demonstrating performance against specific clinical or diagnostic accuracy criteria. The performance data mentioned (fatigue testing, SAR patterns) are engineering-based assessments, not performance against clinical acceptance criteria.
Sample size for the test set and data provenance: Not applicable. There is no "test set" in the context of clinical accuracy or AI performance evaluation. The "testing" refers to mechanical and computational engineering simulations of the device itself.
Number of experts and their qualifications: Not applicable. No experts were used to establish ground truth for a test set, as this is not an AI/ML or clinical efficacy study.
Adjudication method: Not applicable for the same reasons above.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance, often with and without AI assistance, which is not relevant to this device's submission.
Standalone (algorithm only) performance: Not applicable. This device is a physical implant, not an algorithm.
Type of ground truth used: Not applicable. Ground truth, in the context of clinical or diagnostic studies, is not established here. The "results" are from engineering tests.
Sample size for the training set: Not applicable. There is no AI model being trained for this device.
How the ground truth for the training set was established: Not applicable.

Summary of "Performance Data" from the document:

The "Performance Data" section in the 510(k) summary describes engineering evaluations, not clinical performance or AI algorithm performance.

Dynamic fatigue testing: Performed to evaluate the fatigue resilience of the proposed stem.
Range of motion (ROM): Dictated by the ROM of mating liners and previously cleared components.
Computational electromagnetic method: Used to evaluate surface SAR (Specific Absorption Rate) patterns of the stem under MRI radio frequency coil emissions (64-MHz for 1.5Tesla and 128-MHz for 3Tesla MRI).
- Results indicated that for device-induced heating, the maximum 1g averaged SAR values (corresponding maximum temperature rises) are located near the end of the device.
- In-vivo modeling: Indicated a maximum temperature rise after 60 minutes exposure of less than 6 degrees Celsius under specified WB SAR conditions (2W/kg inside tissue and 1W/kg inside bone).

Conclusion from the document:

The submission concludes that the proposed device, the Arthrex Univers Revers Monoblock Stem Size 4/33, is substantially equivalent to the predicate device (K130129) because the only difference is size. It states that the proposed line extension has the same indications for use, is manufactured from the same materials, undergoes the same manufacturing and sterilization processes, has the same packaging, and shelf-life as the predicate. The differences are considered minor and do not raise questions concerning safety or effectiveness.

Summary

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April 10, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of an eagle and a human figure. The FDA acronym is in a blue square, and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue text to the right of the square.

Arthrex Inc. Tiffany Mentzel Principal Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108-1945

Re: K230366

Trade/Device Name: Arthrex Univers Revers Monoblock Stem Size 4/33 Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, HSD Dated: February 10, 2023 Received: February 10, 2023

Dear Tiffany Mentzel:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Farzana Sharmin -S

Farzana Sharmin, PhD Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230366

Device Name

Arthrex Univers Revers Monoblock Stem Size 4/33

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Date Prepared	April 10, 2023
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Name: Tiffany MentzelTitle: Principal Regulatory Affairs SpecialistPhone: (239)-643-5553 ext. 75833Email: Tiffany.Mentzel@Arthrex.com
Trade Name	Arthrex Univers Revers Monoblock Stem Size 4/33
Common Name	Shoulder Prosthesis
Product Code	PHX, HSD
Classification Name	21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis
Regulatory Class	II
Primary Predicate Device	K130129: Univers Revers Shoulder Prosthesis System
Additional Predicates	K170414: Arthrex Univers Revers Apex Humeral StemsK171841: Arthrex Shoulder SystemK181555: Arthrex Fracture Adapter Hemi Shoulder ProsthesisK221232: Univers Revers Humeral Cup Implant
Device Description	This Traditional 510(k) premarket notification is submitted toobtain clearance for the Arthrex Univers Revers MonoblockStem Size 4/33 as a line extension to the Arthrex UniversRevers Humeral Stems cleared under K130129 for use in theArthrex Univers Revers Shoulder Prosthesis System.The Arthrex Univers Revers Monoblock Stem Size 4/33 is ahumeral stem that is manufactured from Titanium (Ti-AL-4V),coated with either Calcium Phosphate (CaP) orHydroxyapatite (HA), and offered sterile.
Indications for Use	The Univers Revers Shoulder Prosthesis System is indicatedfor use in a grossly rotator cuff deficient glenohumeral jointwith severe arthropathy or a previously failed jointreplacement with a gross rotator cuff deficiency. The patient'sjoint must be anatomically and structurally suited to receivethe selected implant(s), and a functional deltoid muscle isnecessary to use the device.The Univers Revers Shoulder Prosthesis System is indicatedfor primary, fracture, or revision total shoulder replacement forthe relief of pain and significant disability due to rotator cuffdeficiency.

Performance Data	(Humeral) Stems are intended for cemented or cementlessapplications for use with Arthrex Humeral SutureCups. Theglenoid baseplate is CaP coated and is intended forcementless use with the addition of screws for fixation.Dynamic fatigue testing was performed to evaluate the fatigueresilience of the proposed stem.
	Range of motion (ROM) of the subject device is dictated bythe ROM of the mating liners and previously clearedcomponents.
	Computational electromagnetic method was used to evaluatethe surface SAR patterns of the Arthrex Univers ReversMonoBlock Stem under MRI radio frequency (RF) coilemissions at 64-MHz associated with 1.5Tesla and 128-MHzassociated with 3Tesla MRI procedures. The surface SARpatterns within the standard ASTM phantom (ASTM F2182-19e2) were obtained. The results indicate that for the deviceinduced heating, the maximum 1g averaged SAR values(corresponding maximum temperature rises) are located nearend of the device.
	Based on the in-vivo modeling, the maximum temperaturerise after 60 minutes exposure is less than 6 degrees Celsiusunder the condition of the WB SAR at 2W/kg inside tissueand WB SAR at 1W/kg inside the bone.
Technological Comparison	Compared to the predicate (K130129), the only difference isthe size. The proposed line extension has the sameindications for use, is manufactured from the same materials,undergo the same manufacturing processing, undergo thesame sterilization process, are packaged in the samepackaging configuration, and have the same shelf-life as thepredicate.
Conclusion	The Arthrex Univers Revers Apex Humeral Stem issubstantially equivalent to the predicate device in which thebasic design features and intended uses are the same. Anydifferences between the proposed device and the predicatedevice are considered minor and do not raise questionsconcerning safety or effectiveness.
	Based on the indications for use, technologicalcharacteristics, and the summary of data submitted, ArthrexInc. has determined that the proposed device is substantiallyequivalent to the currently marketed predicate device.

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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.”