Section 1: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Standard or Revision/Long Humeral Stem Implants
The GLOBAL UNITE Platform Shoulder System is intended for cemented total or hemi-shoulder arthroplasty in treatment of the following:

· A severely painful and/or disabled ioint resulting from osteoarthritis or rheumatoid arthritis
· Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
· Irreducible 3- and 4-part fractures of the proximal humerus
· Ununited humeral head fractures
Avascular necrosis of the humeral head
· Other difficult clinical problems where shoulder arthrodesis or not acceptable (e.g., revision of a failed primary component)
Hemi-shoulder arthroplasty is also indicated for:
· Deformity and/or limited motion
The GLOBAL UNITE™ Reverse Fracture Epiphyseal Component, in conjunction with components from the existing DELTA XTEND™ Reverse Shoulder System and GLOBAL UNITE Platform Shoulder System, is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy 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. It is intended for cemented reverse shoulder arthroplasty in treatment of the following:
· Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
· Irreducible 3- and 4-part fractures of the proximal humerus
· Ununited humeral head fractures
The GLOBAL UNITE Reverse Fracture Epiphyseal Component is only intended for use in the treatment of proximal humeral fractures. Bone preparation instrumentation has not been developed to accommodate its use in a non-fracture press-fit application.
GLOBAL UNITE Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. When used in a total shoulder arthroplasty, the GLOBAL UNITE™ Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.
When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND™ Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented or uncemented use. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.
Section 2: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Short Humeral Stem Implants
GLOBAL UNITE Short Humeral Stem Implants are for uncemented use only. The GLOBAL UNITE Platform Shoulder System with Short Humeral Stem is intended for uncemented total or hemi-shoulder arthroplasty in treatment of the following:
· A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
· Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)
Hemi-shoulder arthroplasty is also indicated for:
Deformity and/or limited motion
GLOBAL UNITE Short Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. 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.
When used in a total shoulder arthroplasty, the GLOBAL UNITE Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only.
When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented use. GLOBAL UNITE Short Humeral Stem Implants are for uncemented use only.

Device Description

The Global Unite Platform Shoulder System is comprised of humeral stem, humeral head, suture collar and epiphyseal (anatomical or reverse) components. The subject Global Unite Short Stem is designed to conserve geometry and design features of the predicate Global Unite standard stem while eliminating the tapered distal stem body.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (GLOBAL UNITE™ Platform Shoulder System). It does not describe any acceptance criteria or studies related to AI/algorithm performance. The "Testing Data" section explicitly states:

Summary of clinical study: "Clinical study was not necessary."
Summary of animal study: "Animal study was not necessary."
Summary of non-clinical study: "Biocompatibility evaluation per ISO10993-1. Dimensional and geometrical equivalency analysis, fatigue strength evaluation, tolerance analysis and torque testing are conducted. MRI compatibility evaluation is conducted for MRI labeling."

This document focuses on establishing substantial equivalence to predicate devices based on design, materials, and mechanical testing, which is typical for implantable medical devices like shoulder prostheses. There is no mention of an AI/algorithm component requiring performance evaluation against an acceptance criterion.

Therefore, I cannot fulfill your request for the specific information regarding AI/algorithm acceptance criteria, performance studies, sample sizes, expert ground truth establishment, or MRMC studies, as this information is not present in the provided document.

Summary

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September 15, 2021

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DePuy Ireland UC % Yayoi Fujimaki Regulatory Project Manager DePuy Mitek, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re: K212710

Trade/Device Name: GLOBAL UNITE™ Platform Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, HSD Dated: August 25, 2021 Received: August 26, 2021

Dear Yayoi Fujimaki:

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 medical devices and radiation-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,

For Michael Owens 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)

K212710

Device Name GLOBAL UNITE™ Platform Shoulder System

Indications for Use (Describe)

Section 1: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Standard or Revision/Long Humeral Stem Implants

The GLOBAL UNITE Platform Shoulder System is intended for cemented total or hemi-shoulder arthroplasty in treatment of the following:

· A severely painful and/or disabled ioint resulting from osteoarthritis or rheumatoid arthritis
· Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
· Irreducible 3- and 4-part fractures of the proximal humerus
· Ununited humeral head fractures
Avascular necrosis of the humeral head
· Other difficult clinical problems where shoulder arthrodesis or not acceptable (e.g., revision of a failed primary component)
Hemi-shoulder arthroplasty is also indicated for:
· Deformity and/or limited motion

The GLOBAL UNITE™ Reverse Fracture Epiphyseal Component, in conjunction with components from the existing DELTA XTEND™ Reverse Shoulder System and GLOBAL UNITE Platform Shoulder System, is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy 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. It is intended for cemented reverse shoulder arthroplasty in treatment of the following:

· Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory

· Irreducible 3- and 4-part fractures of the proximal humerus
· Ununited humeral head fractures

The GLOBAL UNITE Reverse Fracture Epiphyseal Component is only intended for use in the treatment of proximal humeral fractures. Bone preparation instrumentation has not been developed to accommodate its use in a non-fracture press-fit application.

GLOBAL UNITE Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. When used in a total shoulder arthroplasty, the GLOBAL UNITE™ Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.

When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND™ Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented or uncemented use. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.

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Section 2: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Short Humeral Stem Implants

GLOBAL UNITE Short Humeral Stem Implants are for uncemented use only. The GLOBAL UNITE Platform Shoulder System with Short Humeral Stem is intended for uncemented total or hemi-shoulder arthroplasty in treatment of the following:

· A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
· Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)
Hemi-shoulder arthroplasty is also indicated for:
Deformity and/or limited motion

GLOBAL UNITE Short Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. 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.

When used in a total shoulder arthroplasty, the GLOBAL UNITE Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only.

When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented use. GLOBAL UNITE Short Humeral Stem Implants are for uncemented use only.

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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510(k) Summary - K212710

As required by 21 CFR 807.92 and 21 CFR 807.93

Submission Information
Sponsor Name	DePuy Ireland UC
Sponsor Address	Loughbeg, Ringaskiddy Co. Cork Ireland
Sponsor EstablishmentRegistration Number	3015516266
510(k) Contact	Yayoi FujimakiDePuy MitekRegulatory Project Manager	Phone: 508.828.3541Email: yfujima1@its.jnj.com
Date prepared	August 25, 2021
Device Information
Trade or proprietary name	GLOBAL UNITET™ Platform Shoulder System
Common or usual name	Shoulder Prosthesis
Classification name	Shoulder joint metal/polymer semi-constrained cemented prosthesis;Shoulder joint humeral (hemi-shoulder) metallic uncementedprosthesis
Class, regulation	Class II, 21CFR 888.3660, 21CFR 888.3690
Product Code	PHX, KWS, HSD
Classification panel	Orthopedics panel
Legally marketeddevice(s) to whichequivalence is claimed	Primary predicate: GLOBAL UNITE Platform Shoulder Systemshort stem (DePuy Ireland: K202098)Additional predicate: GLOBAL UNITE Platform Shoulder Systemstandard stem (DePuy Ireland: K101996, K170748)
Device description	The Global Unite Platform Shoulder System is comprised ofhumeral stem, humeral head, suture collar and epiphyseal(anatomical or reverse) components. The subject Global Unite ShortStem is designed to conserve geometry and design features of thepredicate Global Unite standard stem while eliminating the tapereddistal stem body.
Indications for use	Section 1: Applicable for the GLOBAL UNITE Platform ShoulderSystem with GLOBAL UNITE Standard or Revision/Long HumeralStem ImplantsThe GLOBAL UNITE Platform Shoulder System is intended forcemented or uncemented total or hemi-shoulder arthroplasty intreatment of the following:• A severely painful and/or disabled joint resulting fromosteoarthritis, traumatic arthritis or rheumatoid arthritis• Fracture of the proximal humerus where the articular surface isseverely comminuted, separated from its blood supply or where the

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surgeon's experience indicates that alternative methods of treatmentare unsatisfactory
• Irreducible 3- and 4-part fractures of the proximal humerus
• Ununited humeral head fractures
• Avascular necrosis of the humeral head
• Other difficult clinical problems where shoulder arthrodesis orresection arthroplasty are not acceptable (e.g., revision of a failedprimary component)
Hemi-shoulder arthroplasty is also indicated for:
• Deformity and/or limited motion
The GLOBAL UNITE Reverse Fracture Epiphyseal Component, inconjunction with components from the existing DELTA XTENDReverse Shoulder System and GLOBAL UNITE Platform ShoulderSystem, is indicated for use in a grossly rotator cuff deficientglenohumeral joint with severe arthropathy or a previously failedjoint replacement with a gross rotator cuff deficiency. The patient'sjoint must be anatomically and structurally suited to receive theselected implant(s), and a functional deltoid muscle is necessary touse the device. It is intended for cemented or uncemented reverseshoulder arthroplasty in treatment of the following:
• Fracture of the proximal humerus where the articular surface isseverely comminuted, separated from its blood supply or where thesurgeon's experience indicates that alternative methods of treatmentare unsatisfactory
• Irreducible 3- and 4-part fractures of the proximal humerus
• Ununited humeral head fractures
The GLOBAL UNITE Reverse Fracture Epiphyseal Component isonly intended for use in the treatment of proximal humeral fractures.Bone preparation instrumentation has not been developed toaccommodate its use in a non-fracture press-fit application.
GLOBAL UNITE Humeral Stems, in conjunction with existingDELTA XTEND Epiphyseal Components, are indicated for use inreverse shoulder arthroplasty in treatment of a grossly deficientrotator cuff joint with severe arthropathy or a previously failed jointreplacement with a grossly deficient rotator cuff joint. The patient'sjoint must be anatomically and structurally suited to receive theselected implant(s), and a functional deltoid muscle is necessary touse the device.
When used in a total shoulder arthroplasty, the GLOBAL UNITEImplants are to be used with DePuy glenoid components. The
glenoid components are for cemented use only. GLOBAL UNITEHumeral Implants are for cemented or uncemented use.
When used in a reverse shoulder arthroplasty, the GLOBAL UNITEand DELTA XTEND Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metagleneimplants are intended for uncemented use only with additional screwfixation. The HA-coated DELTA XTEND Humeral Implants areintended for uncemented use only. Porous-coated epiphyses areintended for cemented or uncemented use. GLOBAL UNITEHumeral Implants are for cemented or uncemented use.
Section 2: Applicable for the GLOBAL UNITE Platform ShoulderSystem with GLOBAL UNITE Short Humeral Implants
GLOBAL UNITE Short Humeral Stem Implants are for uncementeduse only.
The GLOBAL UNITE Platform Shoulder System with ShortHumeral Stem is intended for uncemented total or hemi-shoulderarthroplasty in treatment of the following:• A severely painful and/or disabled joint resulting fromosteoarthritis, traumatic arthritis or rheumatoid arthritis• Other difficult clinical problems where shoulder arthrodesis orresection arthroplasty are not acceptable (e.g. revision of a failedprimary component)
Hemi-shoulder arthroplasty is also indicated for:• Deformity and/or limited motion
GLOBAL UNITE Short Humeral Stems, in conjunction withexisting DELTA XTEND Epiphyseal Components, are indicated foruse in reverse shoulder arthroplasty in treatment of a grosslydeficient rotator cuff joint with severe arthropathy or a previouslyfailed joint replacement with a grossly deficient rotator cuff joint.The patient's joint must be anatomically and structurally suited toreceive the selected implant(s), and a functional deltoid muscle isnecessary to use the device.
When used in a total shoulder arthroplasty, the GLOBAL UNITEImplants are to be used with DePuy glenoid components. Theglenoid components are for cemented use only.
When used in a reverse shoulder arthroplasty, the GLOBAL UNITEand DELTA XTEND Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metagleneimplants are intended for uncemented use only with additional screwfixation. The HA-coated DELTA XTEND Humeral Implants are

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intended for uncemented use only. Porous-coated epiphyses are
intended for cemented or uncemented use. GLOBAL UNITE Short
Humeral Stem Implants are for uncemented use only.
Summary of the Technological Characteristics of the Device Compared to the Predicate Devices
Device	Subject Device:Global Unite Short Stem	Primary Predicate Device:Global Unite Short Stem	Additional PredicateDevice:Global Unite StandardStem
510(k)#	This submission	K202098 (DePuy)	K101996, K170748 (DePuy)
Intended Use	Total anatomical, hemi andtotal reverse arthroplasty	Total anatomical, hemi andtotal reverse arthroplasty	Total anatomical, hemi andtotal reverse arthroplasty
Cement	Cementless	Cementless	Cemented or cementless
Stem Material
Body	Titanium alloy	Titanium alloy	Titanium alloy
Coating	POROCOAT® porouscoating	POROCOAT® porouscoating	POROCOAT® porouscoating
Stem Design
Diameter Size	8mm	10 to 16mm	6 to 16mm
Length	44mm	44 to 61mm	83 to 138mm
Others
Sterilization	Gamma sterile, single use	Gamma sterile, single use	Sterile, single use
Testing Data
Summary of non-clinicalstudy	Biocompatibility evaluation per ISO10993-1. Dimensional andgeometrical equivalency analysis, fatigue strength evaluation,tolerance analysis and torque testing are conducted. MRIcompatibility evaluation is conducted for MRI labeling.
Summary of animal study	Animal study was not necessary.
Summary of clinical study	Clinical study was not necessary.
Conclusion	The results of the non-clinical testing and evaluations havedemonstrated that the subject device is as safe and effective as thepredicate device and therefore, substantially equivalent to thepredicate device

Regulation Number and Section

N/A