The Global UNITE humeral stems, suture collars, epiphyseal components and humeral heads are intended for cemented or uncemented total shoulder or hemi-shoulder replacement in treatment of the following:

A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
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
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)

Hemi-shoulder replacement is also indicated for:

Ununited humeral head fractures
Avascular necrosis of the humeral head
Deformity and/or limited motion

When used in a total shoulder replacement, the Global UNITE implants are to be used with DePuy glenoids. The glenoids are for cemented use only.

When well-fixed, the Global UNITE humeral stems, in conjunction with existing Delta Xtend epiphyseal components, are also indicated for conversion to a reverse, 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. The Delta Xtend metaglene component is HA-coated and is intended for uncemented use with the addition of screws for fixation. The Delta Xtend epiphyseal components are HA-coated and are intended for uncemented use.

The Global UNITE humeral stems, suture collars, epiphyseal components and humeral heads are intended for total shoulder or hemi-shoulder replacement.

Device Description

The Global UNITE Shoulder System includes a two-piece stem design that provides the option to convert a primary fracture prosthesis to a reverse prosthesis, a suture collar, an epiphyseal component, and a humeral head. In the case of failed tuberosity healing, the surgeon will be able to remove the Global UNITE epiphyseal component and replace it with a Delta Xtend Reverse epiphyseal component without removing the well-fixed distal stem.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

It is important to note that this document does not describe the acceptance criteria and study that proves a software algorithm's performance for medical image analysis. Instead, the document is a 510(k) summary for a mechanical orthopedic implant device, specifically the DePuy Global UNITE Shoulder System. Therefore, the questions related to AI/algorithm performance, ground truth, expert adjudication, MRMC studies, and training set do not apply.

The document demonstrates the device's technical characteristics and performance through pre-clinical mechanical testing to establish substantial equivalence to predicate devices.

1. A table of acceptance criteria and the reported device performance

Since this is a mechanical device submission, the "acceptance criteria" are related to mechanical and material performance, as opposed to diagnostic accuracy metrics for software. The document lists the types of pre-clinical tests performed, implying that the device met the performance standards associated with these ASTM standards or equivalent internal protocols, thereby demonstrating substantial equivalence. The specific numerical acceptance criteria and reported results are not provided in this summary but would be detailed in the full 510(k) submission.

Acceptance Criterion (Implicit based on tests)	Reported Device Performance (Implicit success)
Mechanical Strength/Integrity:
Collar taper axial disassembly strength	This test (ASTM F2009-00) implies that the collar-taper interface must maintain a specified minimum axial disengagement force to ensure the components remain securely assembled during use. The device met the performance requirements of this standard.
Collar taper torque disassembly strength	This test implies that the collar-taper interface must maintain a specified minimum torque disengagement force to prevent rotation or loosening of components. The device met the performance requirements.
Collar taper fatigue testing	This testing regimen assesses the ability of the collar-taper interface to withstand cyclic loading without failure or unacceptable degradation, simulating long-term use. The device passed the fatigue testing, demonstrating durability. (and axial disassembly strength post-fatigue, implying it retained sufficient strength after cyclic loading.)*
Humeral head taper axial disassembly strength	This test (ASTM F2009-00) implies the humeral head taper interface must maintain a specified minimum axial disengagement force. The device met the performance requirements of this standard.
Anatomic configuration fatigue testing	This test (ASTM 1378-05) implies the entire construct in an anatomic (forward shoulder) configuration must withstand cyclic loading without failure, simulating implant longevity under physiological stresses. The device passed the fatigue testing.
Reverse configuration fatigue testing	This test (ASTM 1378-05) implies the entire construct in a reverse shoulder configuration must withstand cyclic loading without failure, simulating implant longevity under physiological stresses specific to this configuration. The device passed the fatigue testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the sample size for each performance test. For mechanical testing of medical devices, sample sizes are typically determined by relevant ASTM standards or internal statistically valid protocols, often involving a small number of units (e.g., n=3 or n=5) for each test condition.
Data Provenance: The data is generated from in vitro laboratory testing of the physical device components, performed by the manufacturer, Depuy (Ireland). It is not clinical data (retrospective or prospective) from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The "ground truth" for mechanical performance tests is established by physical measurement against engineering specifications and industry standards (e.g., ASTM F2009-00, ASTM F1378-05), not by expert human interpretation like in diagnostic imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are used for clinical or image-based studies where expert consensus is needed to establish ground truth. For mechanical testing, the "adjudication" is based on objective measurements and compliance with predetermined pass/fail criteria according to established engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. This is not an AI-powered diagnostic device, but a surgical implant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by objective physical measurements against predefined engineering specifications and compliance with relevant ASTM (American Society for Testing and Materials) standards for orthopedic implants.

8. The sample size for the training set

This question is not applicable. There is no "training set" for a mechanical orthopedic implant. The device design and manufacturing processes are informed by engineering principles and prior device experience, not machine learning training data.

9. How the ground truth for the training set was established

This question is not applicable. See the answer to #8.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the logo is a stylized image of a caduceus, a symbol of medicine and healing, with a staff entwined by two snakes and topped by wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2016

Depuy (Ireland) Ms. Rhonda Myer Senior Regulatory Affairs Associate Loghbeg Ringaskiddy Co. Cork, IRELAND

Re: K101996 Trade/Device Name: DePuy Global UNITE 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, MBF, KWS, HSD Dated: November 23, 2010 Received: November 24, 2010

Dear Ms. Myer:

This letter corrects our substantially equivalent letter of December 15, 2010.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreations of the enactment date of the Medical Device Amendments of to commore of they 20, 1970, are excerdance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Oosmetic I so ( roo ) 100 ) 100 the general controls provisions of the Act. The I ou may, morelors, manns 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 may or subject to additions, 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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use Statement

510 (k) Number (if known): K101996

Device Name: DePuy Global UNITE Shoulder System

Indications for Use:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
1. 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
1. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures
1. Avascular necrosis of the humeral head
1. Deformity and/or limited motion

When used in a total shoulder replacement, the Global UNITE implants are to be used with DePuy glenoids. The glenoids are for cemented use only. ",

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use. (21 CFR 807 Subpart C)

. :

K101996

for M. Melkerson
(Division Sign-Off)
Division of Surgical, Orthopedic,

and Restorative Devices

510(k) Number K

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K101996
p 1/3

:・・・

	Section 5: 510 (k) Summary(As required by 21 CFR 807.92 and 21 CFR 807.93)
	DEC 1 5 2010
NAME OF SPONSOR:	DePuy (Ireland)LoughbegRingaskiddyCo. Cork IrelandEstablishment Registration Number: 9616671
510(K) CONTACT:	Rhonda MyerSenior Regulatory Affairs AssociateTelephone: (574) 371-4927Facsimile: (574) 371-4987Electronic Mail: Rmyer7@its.jnj.com
DATE PREPARED:	December 15, 2010
PROPRIETARY NAME:	DePuy Global UNITE Shoulder System
COMMON NAME:	Total and Hemi Shoulder Arthroplasty Prosthesis
CLASSIFICATION ANDREGULATION:	Class II per 21 CFR 888.3660: Shoulder jointmetal/polymer semi-constrained cementedprosthesis (KWS)
	Class II per 21 CFR 888.3690: Shoulder jointhumeral (hemi-shoulder) metallic uncementedprosthesis (HSD)
	Class II per 21 CFR 888.3670: Shoulder jointmetal/polymer/metal non-constrained or semi-constrained porous-coated uncemented prosthesis(MBF)
DEVICE PRODUCT CODE ANDDESCRIPTION:	KWS: Prosthesis, Shoulder, Semi-Constrained,Metal/Polymer CementedHSD: Prosthesis, Shoulder, Hemi-, humeral,Metallic UncementedMBF: Prosthesis. Shoulder, Semi-constrained,Metal/Polymer, Uncemented
PREDICATE DEVICES	DePuy Global AP, K063652 (stem) andK060874 (head)DePuy Delta Xtend, K071379

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DEVICE DESCRIPTION:

INDICATIONS AND INTENDED USE:

Indications:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
1. 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
1. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures
1. Avascular necrosis of the humeral head
1. Deformity and/or limited motion

When used in a total shoulder replacement, the Global UNITE implants are to be used with DePuy glenoids. The glenoids are for cemented use only.

When well-fixed, the Global UNITE humeral stems, in conjunction with existing Delta Xtend epiphyseal components, are also indicated for conversion to a reverse, in treatment of a grossly deficient roator 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. The Delta Xtend metaglene component is HA-coated is intended for uncemented use with the addition of screws for fixation. The Delta Xtend epiphyseal components are HA-coated and are intended for uncemented use.

Intended Use:

The Global UNITE humeral stems, suture collars, epiphyseal components and humeral heads are intended for total shoulder or hemi-shoulder replacement.

BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on the similarities in intended use, indications for use, materials, and design, DePuy believes the subject Global UNITE Shoulder System is substantially equivalent to the previously beneves the subject Global AP and Delta Xtend Shoulder Systems, cleared in K063652, K060874 and K071379. :

Technological Characteristics

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K01996
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The technological characteristics of the DePuy Global UNITE Shoulder System are similar to the predicate devices, including geometry, design, size range, material, and porous coating. The differences include the following: The predicate Global AP only has suture holes on the stem, and the subject Global UNITE System has suture holes on the stem and also a suture collar for tuberosity reattachment. The predicate Global AP stem has a female taper with linking components that attach to the head while the subject Global UNITE has a male taper on the epinhyseal component that attaches to the head. The predicate Global AP does not have a modular epiphyseal component and the subject Global UNITE does have a modular epiphyseal component. The predicate Global AP heads have more material on the underside of the head than the Global UNITE heads. The predicate Delta Xtend does not have sizes 6 and 8 while the subject Global UNITE does offer sizes 6 and 8.

Performance Data

The Global UNITE Shoulder System was subjected to the following pre-clinical testing: Collar taper axial disassembly strength (ASTM F2009-00), Collar taper torque disassembly strength, Collar taper fatigue testing and axial disassembly strength, Humeral head taper axial disassembly strength (ASTM F2009-00), Anatomic configuration fatigue testing (ASTM 1378-05, and Reverse configuration fatigue testing (ASTM 1378-05).

Conclusion

DePuy believes the DePuy Global UNITE Shoulder System is substantially equivalent to the predicate devices, Global AP and Delta Xtend, as confirmed through device testing and production activities. No new issues of safety and efficacy have been raised with the Global UNITE Shoulder System.

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.”