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.

Only the titanium alloy humeral stem components and the cobalt-chrome alloy humeral stem components, which are marketed under the Global Shoulder name, are intended for press-fit or cemented fixation. The glenoid components are for cemented use only.

Device Description

The Global Shoulder components, which are the subjects of this submission, consist of a humeral body (stem) and a humeral head. Like the predicate devices, the components are modular in that they employ a morse-type taper lock system, the modular head having the male taper and the body with the female taper. Both components (head and body) will be made from Co-Cr-Mo alloy.

The subject Global humeral stem is similar to the current Global humeral stem in that there are four proximal fins, a proximal collar, and a fluted distal stem. The fins are perforated to accommodate the sutures necessary to reconstruct the proximal humerus.

The Global humeral head is similar to the current Global head in that it is fitted with an identical locking taper, is semi-spherical in design, and it has similar head sizes and heights. The size range will allow options for joint tensioning and restoration of normal joint biomechanics.

Modifications and Reason: Although the currently marketed design already includes the indication for use in fracture cases, the need for a smaller proximal humeral stem has been identified for those patients with smaller metaphyses and for use in fracture cases when the predicate Global humeral component is too large for the particular patient. DePuy believes the subject humeral components, containing the following described modifications, fill this need.

The proximal humeral body has been reduced in the A/P and M/L dimensions to ease repositioning of the fractured humeral tuberosities.
The lateral fin has a reduced profile to prevent contact with the biceps tendon and to avoid tilting the prosthesis in a varus orientation.
The medial fin has a suture hole added for passing of sutures to reposition fractured tuberosities.
The lateral fin has one centrally located suture hole versus the three suture holes in the current design.
The collar diameter has been reduced and contains a flat profile to mate with humeral heads.
The humeral head has been modified to contain a recess in the undersurface in order to mate with the collar of the humeral stem component. The collar/head design reduces collar/head gap and increases the effective articular surface area.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the DePuy Global™ Shoulder device, specifically the Global™ Fx Humeral Stem and Global™ Advantage® Humeral Head.

This document describes the device, its intended use and indications, and the basis for its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as one would typically find for a medical AI or diagnostic device.

Instead, this document focuses on demonstrating that the modified components (Global™ Fx Humeral Stem and Global™ Advantage® Humeral Head) are substantially equivalent to existing, already-cleared Global Shoulder components (K911686, K914695). The "acceptance criteria" here implicitly refer to the FDA's regulatory requirements for substantial equivalence for a medical device that does not involve AI or a diagnostic algorithm.

Therefore, I cannot provide the requested information in the format because the provided document does not contain:

A table of acceptance criteria and reported device performance directly related to an AI/diagnostic algorithm.
Sample sizes for test sets, data provenance, or expert involvement for ground truth establishment.
Adjudication methods.
Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone algorithm performance studies.
Training set details or ground truth establishment for a training set.

The "study" in this context is the comparison of design, materials, manufacturing processes, indications for use, and intended use to predicate devices, as opposed to a clinical performance study with statistical metrics.

Summary of Device and Basis for Equivalence (as presented in the document):

Device: Global™ Fx Humeral Stem and Global™ Advantage® Humeral Head (humeral stem and head components for shoulder arthroplasty).

Basis of Substantial Equivalence:
The document states that the fundamental scientific technology has not changed from previously FDA-cleared Global Shoulder humeral components (K911686). The intended use and indications for use also remain unchanged. The new components address a need for a smaller proximal humeral stem for patients with smaller metaphyses and fracture cases.

Modifications (minor design changes):

Reduced A/P and M/L dimensions of the proximal humeral body.
Reduced profile of the lateral fin.
Added a suture hole to the medial fin.
Changed lateral fin to one centrally located suture hole (from three).
Reduced and flattened collar diameter.
Humeral head modified with a recess in the undersurface to mate with the stem collar.

Conclusion for Equivalence:
DePuy believes the modified components are substantially equivalent to the predicate devices (K911686 and K914695) based on conformance with design control procedures (21 CFR 820.30), similarities in design, commonly used materials, sterilization processes, indications for use, and intended use. The FDA concurred with this assessment for substantial equivalence (K984541).

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo features a solid black circle to the left of the name "DePuy" in a bold, sans-serif font. Below the name is the text "a Johnson-Johnson company" in a smaller font. The logo is simple and professional, reflecting the company's focus on medical devices and healthcare.

K98454/

JAN 1 4 1999

Summary of Safety and Effectiveness

NAME OF SPONSOR:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Est. Reg. No. 1818910
510(k) CONTACT:	Arlene C. Saull, RACSr. Regulatory AssociatePhone: (219) 372-7176FAX: (219) 267-7098E-Mail: Arlene_Saull@ccgate.depuy.com
TRADE NAME:	Global™ Shoulder● Global™ Fx Humeral Stem● Global™ Advantage® Humeral Head
COMMON NAME:	Shoulder prosthesis, humeral stem & head components
CLASSIFICATION:	When used as a hemi-shoulder, it is a Class II device per 21 CFR §888.3690When used as a total shoulder, it is a Class III device per 21 CFR §888.3660
DEVICE PRODUCT CODE:	87 HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II)87 KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (Class III)
SUBSTANTIALLY EQUIVALENT DEVICE:	Global Shoulder: K911686, K914695

DEVICE DESCRIPTION:

Continued on next page . . . . .

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the DePuy logo. The logo consists of a black circle on the left, followed by the word "DePuy" in a bold, sans-serif font. Below the word "DePuy" is the phrase "a Johnson & Johnson company" in a smaller font.

Summary of Safety and Effectiveness (Continued)

The proximal humeral body has been reduced in the A/P and M/L dimensions to ease ■ repositioning of the fractured humeral tuberosities.
The lateral fin has a reduced profile to prevent contact with the biceps tendon and to avoid tilting the prosthesis in a varus orientation.
트 The medial fin has a suture hole added for passing of sutures to reposition fractured tuberosities.
. The lateral fin has one centrally located suture hole versus the three suture holes in the current design.
해 The collar diameter has been reduced and contains a flat profile to mate with humeral heads.
미 The humeral head has been modified to contain a recess in the undersurface in order to mate with the collar of the humeral stem component. The collar/head design reduces collar/head gap and increases the effective articular surface area.

INTENDED USE:

The subject humeral stem and humeral head are intended for use in total or hemiarthroplasty. When used for total shoulder arthroplasty, the subject components are designed to be used with the existing Global cemented glenoid components cleared in K905786 & K914000. The humeral stem is intended to be used with bone cement or in press-fit applications (cementless).

Continued on next page . . . . .

000011

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo features a black circle to the left of the name "DePuy" in a stylized font. Below the name is a horizontal line, and beneath that is the text "a Johnson & Johnson company" in a smaller font. The logo is simple and professional, reflecting the company's association with healthcare and medical devices.

Summary of Safety and Effectiveness (Continued)

INDICATIONS FOR USE:

Total or hemi-shoulder replacement is indicated for:

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.

CAUTION:

The cobalt-chrome alloy humeral components, which are marketed under the HRP Shoulder name and all glenoid components are for CEMENTED USE ONLY.

Continued on next page . . . . .

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo features a solid black circle to the left of the name "DePuy" in a bold, sans-serif font. Below the name is the text "a Johnson & Johnson company" in a smaller, serif font.

Summary of Safety and Effectiveness (Continued)

BASIS OF SUBSTANTIAL EQUIVALENCE:

The fundamental scientific technology of the humeral stem and head has not changed from the FDA cleared (K911686) Global Shoulder humeral components. The intended use and indications for use of the subject Global humeral body and head, as described in its labeling has not changed from the FDA cleared (K911686) Global Shoulder devices. The addition of the Global Fx Stem to the Global Shoulder line does not require an application for a new indication because the fracture indication already exists for the currently marketed design. Like the predicate devices in K911686, the humeral head will be manufactured from cobalt chrome alloy. The humeral stem will be manufactured from F-75 cobalt chrome alloy, identical to the humeral component cleared in K914695. With the exception of the minor design modifications previously described, the subject humeral stem and humeral head are identical to the Global Shoulder devices cleared in K911686 and K914695.

Based on conformance with the design control procedures requirements as specified in 21 CFR 820.30, similarities of design, commonly used materials, sterilization processes, indications for use, and intended use, DePuy believes that the subject humeral stem and humeral head components are substantially equivalent to the FDA cleared (K911686 and K914695) Global Shoulder components.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a person.

JAN 1 4 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arlene C. Saull, RAC Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

K984541 Re: Global™ Fx Humeral Stem, Global™ Advantage® Humeral Head Requlatory Class: III Product Codes: KWT and HSD Dated: December 18, 1998 December 21, 1998 Received:

Dear Ms. Saull:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{5}------------------------------------------------

Page 2 - Arlene C. Saull, RAC

This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for DePuy Synthes. The logo consists of a black circle on the left, followed by the word "DePuy" in a bold, sans-serif font. The "®" symbol is located at the bottom right of the word "DePuy". The logo is simple and modern, and it is likely used to represent the company's brand.

K984541 510(k) Number (if known)

Device Name: Global™ Shoulder

Indications for Use:

Total or hemi-shoulder replacement is indicated for:

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.

CAUTION: The cobalt-chrome alloy humeral components, which are marketed under the HRP Shoulder name and all glenoid components are for CEMENTED USE ONLY.

Concurrence of CDRH, Office of Device Evaluation

P. Cottofo

ral Restorative Devices

Prescription Use
(Per 21 CFR 801.109) X

Over-The-Counter Use

000009

Regulation Number and Section

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”