The DePuy Synthes DELTA XTEND™ Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:
• severe arthropathy and/or;
• a previous 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. Porous-coated epiphysis are indicated for use in total shoulder replacement only.

The metaglene component is either HA coated or porous-coated and is intended for cementless use with the addition of screws for fixation. Central screws can only be used with the porous-coated metaglenes and are required to be used with porous-coating augmented metaglenes.

The modular humeral stem is HA coated and is intended for cementless use. The HA coated humeral epiphysis is intended for cementless use. The porous-coated epiphysis is intended for cementless use.

All other metallic components are intended for cemented use only.

Device Description

The DELTA XTEND Reverse Shoulder System consists of humeral stems, modular epiphysis, humeral spacers, humeral cups, glenospheres, metaglenes and metaglene screws used for reverse shoulder arthroplasty. Humeral heads can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoid components.

The metaglenes are available in various design configurations including standard and augmented designs. The metaglenes allow for the placement of a central screw down the center of the post. A separate collet component is inserted into the metaglene post to receive the locking screw of the glenospheres.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the DELTA XTEND Reverse Shoulder System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study or AI-driven performance metrics.

Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set details for AI/algorithm performance are not applicable to this 510(k) submission.

This submission is for a mechanical medical device (shoulder prosthesis), not a diagnostic or AI-based device that would typically undergo studies with the kind of performance metrics and ground truth establishment outlined in the request. The "Performance Data" section lists various mechanical tests (e.g., Pullout Evaluation, Fatigue Evaluation, Micromotion Evaluation), which are standard for orthopedic implants to demonstrate their physical properties and durability, ensuring they are comparable to existing, legally marketed devices.

Here's why the queried information is not present in the provided text:

Acceptance Criteria & Reported Performance Table: The document doesn't provide numerical acceptance criteria for clinical performance (like sensitivity/specificity for a diagnostic device) or reported performance against such criteria. Instead, it demonstrates equivalence through design, materials, and mechanical testing.
Sample Size & Data Provenance (for test/training sets): These are relevant for clinical trials or AI model validation datasets. For a 510(k) for a mechanical implant, the "sample size" would refer to the number of devices or test specimens used in engineering bench testing, not patient data for algorithm training/testing. Such detailed numbers are typically found in the full technical reports submitted to FDA, not in the summary document.
Expert Ground Truth, Adjudication, MRMC, Standalone Performance: These concepts are specific to diagnostic devices, especially those involving image interpretation or AI algorithms where human readers' performance is augmented or replaced. They are not applicable to the evaluation of a shoulder prosthesis itself.
Type of Ground Truth: For this device, the "ground truth" would be established through engineering specifications, material science, biomechanical principles, and the established performance of predicate devices. There wouldn't be "expert consensus" or "pathology" in the sense of diagnosing a condition; rather, it refers to engineering and clinical consensus on mechanical properties and surgical outcomes.
Training Set Sample Size & Ground Truth Establishment: Again, these are AI/machine learning terms and do not apply to this type of device submission.

In summary, the provided document is a regulatory submission for a physical implant, not an AI/diagnostic device. The "study" referenced in the document (under "Performance Data") refers to benchtop mechanical and material testing, performed to demonstrate that the device is as safe and effective as its predicate devices, rather than a clinical study evaluating diagnostic accuracy or human performance improvement.

Summary

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July 22, 2021

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DePuy Ireland UC % Jaclyn Cincotta Regulatory Project Manager DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K203694

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, KWS Dated: June 23, 2021 Received: June 24, 2021

Dear Jaclyn Cincotta:

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)

K203694

Device Name DELTA XTEND Reverse Shoulder System

Indications for Use (Describe)

The DePuy Synthes DELTA XTEND™ Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:

• severe arthropathy and/or;

· a previous 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.

The modular humeral stem is HA coated and is intended for cementless use. The HA coated humeral epiphysis is intended for cementless use. The porous-coated epiphysis is 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

Submitter Information
Sponsor Name	DePuy Ireland UC
Sponsor Address	LoughbegRingaskiddyCo. Cork Ireland
Sponsor EstablishmentRegistration Number	9616671
510(k) Contact	Jaclyn CincottaRegulatory Affairs Project ManagerTelephone: (508) 828-3269Fax: (508) 977-6409Email: jcincott@its.jnj.comAddress: 700 Orthopaedic Drive, Warsaw, IN 46582, USA
Date Prepared	22 July 2021
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 cemented prosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	21 CFR 888.3660
Product Code(s)	PHX, KWS
Legally Marketed Device(s)to Which Equivalence isClaimed	Predicate Devices: DePuy Synthes DELTA XTEND Reverse ShoulderSystem (K120174, K192855) and Tornier Aequalis PerFORM Reversedand Aequalis PerFORM+ Reversed Glenoid Shoulder Prosthesis(K161742, K183696)Reference Device: DePuy Synthes GLOBAL UNITE Platform ShoulderSystem (K170748)
Reason for 510(k)Submission	Line extension to the DePuy Synthes DELTA XTEND ReverseShoulder System to add additional metaglene and metaglene screwdevices.

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Device Description	The DELTA XTEND Reverse Shoulder System consists of humeralstems, modular epiphysis, humeral spacers, humeral cups, glenospheres,metaglenes and metaglene screws used for reverse shoulder arthroplasty.Humeral heads can be used in hemi-shoulder arthroplasty in place of thehumeral cup and glenoid components.The metaglenes are available in various design configurations includingstandard and augmented designs. The metaglenes allow for theplacement of a central screw down the center of the post. A separatecollet component is inserted into the metaglene post to receive thelocking screw of the glenospheres.
Intended Use of the Device	The DELTA XTEND Reverse Shoulder System is intended for use in totalor hemi-shoulder arthroplasty in patients with 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 previous failed joint replacement and/or;• fracture-dislocations of the proximal humerus where the articularsurface is severely communited, separated from its blood supply orwhere the surgeon's experience indicates that alternative methods oftreatment are unsatisfactory
	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.
	DELTA XTEND hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revisionof a previously failed DELTA XTEND Reverse Shoulder. Porous-coated epiphysis are indicated for use in total shoulder replacement only.
	The metaglene component is either HA coated or porous-coated and isintended for cementless use with the addition of screws for fixation.Central screws can only be used with the porous-coated metaglenes andare required to be used with porous-coated augmented metaglenes.
	The modular humeral stem is HA coated and is intended for cementlessuse. The HA coated humeral epiphysis is intended for cementless use.The porous-coated epiphysis is intended for cemented or cementlessuse.
	All other metallic components are intended for cemented use only.
Comparison of TechnologicalCharacteristics with thePredicate Device	The DELTA XTEND Reverse Shoulder System has the same intendeduse and the same fundamental scientific technology as the predicatedevices. The standard metaglenes are similar to those of the DePuySynthes DELTA XTEND Reverse Shoulder System (K120174) and theaugmented metaglenes and central screws are similar to those of theTornier Aequalis PerFORM Reversed and Aequalis PerFORM+Reversed Glenoid Shoulder Prosthesis (K161742, K183696). Theporous-coating of the subject metaglene devices is similar to theDELTA XTEND Reverse Shoulder System (epiphysis devices)(K192855) and reference device DePuy Synthes GLOBAL UNITEPlatform Shoulder System (reverse epiphysis devices) (K170748)

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Performance Data	The following tests were performed on the subject devices of theDELTA XTEND Reverse Shoulder System to demonstrate substantialequivalence of safety and efficacy with the predicate devices:Pullout Evaluation Fatigue Evaluation Micromotion Evaluation Taper Dissociation Evaluation Torque to Failure Evaluation Insertion Force Evaluation Range of Motion Evaluation MRI Compatibility Evaluation
Clinical Data	No clinical studies were required to demonstrate substantial equivalence.
Conclusion	The subject devices of the DELTA XTEND Reverse Shoulder Systemare substantially equivalent to the metaglene/baseplate and screwdevices of the predicate DePuy Synthes DELTA XTEND ReverseShoulder System (K120174, K192855) and the Tornier AequalisPerFORM Reversed and Aequalis PerFORM+ Reversed GlenoidShoulder System (K161742, K183696).

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.”