The DELTA XTEND Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:
• severe arthropathy and/or;
• a previously failed joint replacement and/or:
• fracture-dislocations 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 is unsatisfactory
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.
DELTA XTEND hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND Reverse Shoulder.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.
The modular humeral stem and humeral epiphysis components are HA coated and intended for cementless use. All other metallic components are intended for cemented use only.

Device Description

The DELTA XTEND Reverse Shoulder System is currently cleared and marketed by DePuy Synthes and is comprised of multiple humeral and glenoid implant components. These are provided as separate, standalone devices and may be used in conjunction to form a total shoulder prothesis. This submission is pertinent to only those system components which are HA coated:
Humeral Implants: Modular humeral stems Modular epiphysis
Glenoid Implants: Metaglenes

AI/ML Overview

This document describes a 510(k) premarket notification for the DELTA XTEND™ Reverse Shoulder System. The submission is for the introduction of an additional manufacturing and sterilization site for the hydroxyapatite (HA) coated system components and an update to packaging configuration for these components. No new device performance claims are being made beyond substantial equivalence to the predicate device.

Here's the information broken down as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is primarily for the introduction of an additional manufacturing and sterilization site and packaging updates, and claims substantial equivalence to a previously cleared device, the "acceptance criteria" are the standards for manufacturing, sterilization, and material characterization, and the "reported device performance" is that the device meets these standards, thereby maintaining equivalence to the predicate.

Acceptance Criteria (Tests Performed)	Reported Device Performance
Biological Safety: Per ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"	The device demonstrated biological safety per ISO 10993-1. (Implied by the conclusion of substantial equivalence based on these tests.)
Packaging Validation: Per ISO 11607-1 and ISO 11607-2 utilizing ISTA 3A	Packaging was validated per ISO 11607-1 and ISO 11607-2 utilizing ISTA 3A. (Implied by the conclusion of substantial equivalence based on these tests.)
Sterilization Validation: Per AAMI ANSI ISO 11137-1: 2006/(R)2010 and AAMI ANSI ISO 11137-2: 2013	Sterilization was validated per AAMI ANSI ISO 11137-1: 2006/(R)2010 and AAMI ANSI ISO 11137-2: 2013. (Implied by the conclusion of substantial equivalence based on these tests.)
Characterization Testing of Hydroxyapatite Coating: As recommended per FDA Guidance: "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implant"	The HA coating characterization met the recommendations of the FDA Guidance. (Implied by the conclusion of substantial equivalence based on these tests.)
Functional Equivalence: The subject device components (Modular Humeral Stem, Modular Epiphysis, and Metaglene with HA coating) must demonstrate the same intended use, materials, and design characteristics as the predicate device (DELTA XTEND™ Reverse Shoulder System, K062250, K071379, K120174) to uphold substantial equivalence, despite new manufacturing and sterilization sites, and packaging configuration updates.	The subject device components were found to have the same intended use, materials (titanium alloy with HA coating), and modular design characteristics (epiphysis and humeral stem sizes, metaglene fixation with screws) as the predicate device. This supports the claim of substantial equivalence for safety and efficacy.

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

The provided document describes non-clinical tests (biological safety, packaging, sterilization, HA coating characterization) rather than a clinical study with a "test set" of patients or data in the traditional sense of AI/diagnostic device evaluation.

Sample Size for Test Set: Not applicable as this is not a clinical study on patient data for diagnostic or prognostic performance. The "samples" would be the manufactured device components undergoing the specified non-clinical tests. The document does not specify the number of units tested for each non-clinical test, but it is implied that a sufficient number were tested to satisfy the respective ISO and AAMI standards and FDA guidance.
Data Provenance: Not applicable in terms of country of origin of patient data or retrospective/prospective nature, as no clinical data or patient data was involved in this particular 510(k) submission. The data provenance would be from laboratory testing performed at the manufacturer's facility or certified testing labs.

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

Not applicable. No "ground truth" based on expert consensus on patient data was established, as this was a non-clinical submission.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication by experts on clinical data was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical implant (shoulder prosthesis), not an algorithm or AI software. Therefore, an "algorithm only" or "standalone" performance study is not relevant.

7. Type of Ground Truth Used

The "ground truth" in this context refers to established standards and scientific principles that the non-clinical tests aim to verify.

Biological Safety: Ground truth is defined by the acceptable levels of biological response as outlined in ISO 10993-1.
Packaging: Ground truth is the ability of packaging to maintain sterility and product integrity as defined by ISO 11607 series and ISTA 3A.
Sterilization: Ground truth is the sterility assurance level (SAL) achieved according to AAMI ANSI ISO 11137 series.
HA Coating Characterization: Ground truth is the physical and chemical properties of the HA coating meeting the specifications and recommendations provided in the FDA Guidance for HA-coated orthopedic implants.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this device.

Summary

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October 04, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

DePuy(Ireland) % Ashley Goncalo Project Manager-Regulatory Affairs DePuy Orthopaedies, Inc. 700 Orthopaedies Dr. Warsaw, Indiana 46582

Re: K192448

Trade/Device Name: DELTA XTEND™ Reverse 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, HSD Dated: September 4, 2019 Received: September 6, 2019

Dear Ashley Goncalo:

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

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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) 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 (OS) 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,

Michael C. Owens 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192448

Device Name DELTA XTEND Reverse Shoulder System

Indications for Use (Describe)

The DELTA XTEND Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: · severe arthropathy and/or:

· a previously failed joint replacement and/or:

· fracture-dislocations 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.

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.

DELTA XTEND hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND Reverse Shoulder. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem and humeral epiphysis components are HA coated and intended for cementless use. All other metallic components are intended for cemented use only.

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)

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510(k) Summary

As required by 21 CFR 807.92 and 21 CFR 807.93

Submission Information
Sponsor Name	DePuy (Ireland)
Sponsor Address	Loughbeg, Ringaskiddy Co. Cork Ireland
Sponsor EstablishmentRegistration Number	9616671
510(k) Contact	Ashley GoncaloDePuy SynthesRegulatory Project Manager
Date prepared	September 4, 2019
Device Information
Trade or proprietary name	DELTA XTEND™ Reverse Shoulder System
Common or usual name	Shoulder Prosthesis
Classification name	Shoulder joint metal/polymer semi-constrained cementedprosthesis
Class, regulation	Class II, 21 CFR 888.3660
Product Code	PHX, HSD
Classification panel	Orthopedics panel
Legally marketeddevice(s) to whichequivalence is claimed	DELTA XTEND Reverse Shoulder System (DePuy: K062250,K071379, K120174)
Reason for 510(k)submission	Introduction of an additional manufacturing and sterilization sitefor the hydroxyapatite (HA) coated system components that aremarketed as part of the DELTA XTEND Reverse ShoulderSystem. Additionally, there is an update to packagingconfiguration for these system components.
Device description	The DELTA XTEND Reverse Shoulder System is currentlycleared and marketed by DePuy Synthes and is comprised ofmultiple humeral and glenoid implant components. These areprovided as separate, standalone devices and may be used inconjunction to form a total shoulder prothesis. This submission ispertinent to only those system components which are HA coated:Humeral Implants: Modular humeral stems Modular epiphysis Glenoid Implants: Metaglenes
Intended use of the device	The DELTA XTEND Reverse Shoulder prosthesis is intended foruse in total or hemi-shoulder arthroplasty procedures in patientswith non-functional rotator cuffs, with or without bone cement.
Indications for use	The DELTA XTEND Shoulder Prosthesis is indicated for use intreatment of a grossly deficient rotator cuff joint with:• severe arthropathy and/or;• a previously failed joint replacement and/or:• fracture-dislocations of the proximal humerus where thearticular surface is severely comminuted, separated from itsblood supply or where the surgeon's experience indicatesthat alternative methods of treatment are unsatisfactoryThe patient's joint must be anatomically and structurally suited toreceive the selected implant(s), and a functional deltoid muscle isnecessary to use the device.DELTA XTEND hemi-shoulder replacement is also indicated forhemi-arthroplasty if the glenoid is fractured intraoperatively or forthe revision of a previously failed DELTA XTEND ReverseShoulder.The metaglene component is HA coated and is intended forcementless use with the addition of screws for fixation.The modular humeral stem and humeral epiphysis components areHA coated and intended for cementless use. All other metalliccomponents are intended for cemented use only.

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECTDEVICE COMPARED TO THE PREDICATE DEVICE
Characteristic	Subject Device:DePuy Synthes DELTAXTEND™ Reverse ShoulderSystem	Predicate Device:DePuy Synthes DELTAXTEND™ Reverse ShoulderSystem (K062250, K071379,K120174)
Intended Use	Reverse shoulder arthroplasty	Reverse shoulder arthroplasty
Material
Humeral Implants(ModularHumeral Stem,ModularEpiphysis)	Titanium alloy with HA coating	Titanium alloy with HA coating
Glenoid Implants(Metaglene)
Design
Humeral Implants(ModularHumeral Stem,ModularEpiphysis)	Modular, without cement,composed of an epiphysis and ahumeral stem made out of titaniumand coated with hydroxyapatite.The epiphysis is available instandard or long version and in twosizes in order to be able to adapt aswell as possible to the humananatomy. The distal stem isavailable in several diameters tomaximize the adaptability ofhumeral canal.	Modular, without cement,composed of an epiphysis and ahumeral stem made out of titaniumand coated with hydroxyapatite.The epiphysis is available instandard or long version and in twosizes in order to be able to adapt aswell as possible to the humananatomy. The distal stem isavailable in several diameters tomaximize the adaptability ofhumeral canal.
Glenoid Implant(Metaglene)	The Glenoid Implant is comprisedof a glenosphere that is fixed on themetaglene by a conical joint and acentral pin.The metaglene is coated withhydroxyapatite and is fixed insidethe bone with 4 screws. Thissubmission pertains to the metaglenecomponent of the Glenoid Implantonly.	The Glenoid Implant is comprisedof a glenosphere that is fixed on themetaglene by a conical joint and acentral pin.The metaglene is coated withhydroxyapatite and is fixed insidethe bone with 4 screws
PERFORMANCE DATA

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SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The following tests were performed on the DELTA XTEND Reverse Shoulder System to demonstrate substantial equivalence of safety and efficacy with the predicate devices:

Biological safety per ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: ● Evaluation and Testing".
Packaging validation per ISO 11607-1 and ISO 11607-2 utilizing ISTA 3A. ●
Sterilization validation per AAMI ANSI ISO 11137-1: 2006/(R)2010 and AAMI ANSI ● ISO 11137-2: 2013

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Characterization testing of Hydroxyapatite Coating as recommended per FDA ● Guidance: "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implant"

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

No clinical tests were conducted to demonstrate substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The HA coated Modular Humeral Stem, Modular Epiphysis, and Metaglene of the DELTA XTEND Reverse Shoulder System is substantially equivalent to the HA coated Modular Humeral Stem, Modular Epiphysis, and Metaglene of the predicate DePuy Synthes DELTA XTEND Reverse Shoulder System (K062250, K071379, K120174).

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.”