A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis;
Fracture-dislocations of the proximal humerus where the articular surfaces are severely compromised or where conventional methods of treatment are unsatisfactory;
Other difficult clinical management problems where arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).

The glenoid components of the Global Total Shoulder System are intended for cemented use only for the above indications.

Hemi-shoulder replacement is also indicated for:

Ununited humeral head fractures of long duration
Avascular necrosis of the humeral head

Device Description

The DePuy Global Shoulder Glenoid is intended use as the glenoid component in total shoulder arthroplasty, completed using humeral components of the DePuy Global Total Shoulder System. The DePuy Global Shoulder Glenoid is manufactured in six sizes from Ultra High Molecular Weight Polyethylene (UHMWPe). The articular (lateral) surface is designed to articulate with the head of an existing, commercially available Global Shoulder humeral prosthesis. The fixation (medial) surface is convex and is designed with four pegs, one centrally located peg and three peripheral pegs placed in a triangular configuration. The center peg is fitted with radially extending fins which provide resistance to pullout. The space around the peripheral pegs is designed to provide interdigitation with cement. The main rotational motion caused by translation of the prosthetic humeral head is possible in the prosthetic humeral head.

AI/ML Overview

The provided document is a 510(k) premarket notification for the DePuy Global Shoulder Glenoid. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a de novo clinical study to establish new acceptance criteria and prove performance against those criteria. Therefore, the information requested in points 1 through 9, which relate to a study proving device performance against specific acceptance criteria, is not directly available in this document.

However, I can extract information related to the device description, intended use, and the basis of substantial equivalence as provided.

Device Description and Intended Use:

The DePuy Global Shoulder Glenoid is intended for use as the glenoid component in total shoulder arthroplasty, completed using humeral components of the DePuy Global Total Shoulder System. It is manufactured in six sizes from Ultra High Molecular Weight Polycht Polychylcuce (UHMWPe) and is designed to articulate with the head of an existing, commercially available Global Shoulder humeral prosthesis. The fixation surface is convex and designed with four pegs (one central, three peripheral) for interdigitation with cement.

Intended Use for the Global Total Shoulder System (of which this glenoid is a component):

The humeral components are intended for cemented total shoulder replacement for:

Severely painful and/or disabled joints resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis.
Fracture-dislocations of the proximal humerus where articular surfaces are severely compromised or conventional methods are unsatisfactory.
Other difficult clinical management problems (e.g., revision of a failed primary component).

The glenoid components are intended for cemented use only for the above indications.

Hemi-shoulder replacement is also indicated for:

Ununited humeral head fractures of long duration.
Avascular necrosis of the humeral head.

Basis of Substantial Equivalence:

The DePuy Global Shoulder Glenoid is considered substantially equivalent to the currently marketed cemented DePuy Global Shoulder Pegged and Keeled Glenoid components. The basis of equivalence is in terms of:

Material (UHMWPe)
Articular and fixation surface geometries
Use as the cemented glenoid components of the Global Total Shoulder System.

Regarding the specific points 1-9 for a study proving acceptance criteria:

Based on the nature of a 510(k) submission, this document does not contain a study designed to prove the device meets pre-defined acceptance criteria through a specific clinical or performance trial with calculated sample sizes, ground truth establishment, or expert adjudication as typically seen in novel device approvals or performance claims.

Therefore, I cannot provide the requested information:

A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on equivalence, not setting new performance criteria.
Sample size used for the test set and the data provenance: Not provided. No specific "test set" for a performance study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method for the test set: Not provided.
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 is not an AI device, so an MRMC study is not relevant here and is not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI device.
The type of ground truth used: Not provided.
The sample size for the training set: Not provided.
How the ground truth for the training set was established: Not provided.

The document is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device, allowing the DePuy Global Shoulder Glenoid to enter the market. It does not outline a clinical study proving its performance against novel acceptance criteria. The "study" here is the comparison to the predicate device to satisfy the substantial equivalence requirements of the 510(k) pathway.

Summary

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

Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The string starts with the letter 'K', followed by the numbers '981487'. The handwriting is somewhat stylized, with the 'K' having a distinct stroke and the numbers being clearly formed.

JUL 13 1998

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, Indiana 46581-0988
FIRM CONTACT:	Sally FoustRegulatory Submissions Associate(219) 372-7455; FAX (219) 267-7098E-Mail: Sally_Foust@ccgate.depuy.com
TRADE NAME:	DePuy Global Shoulder Glenoid
COMMON NAME:	Shoulder Prosthesis
DEVICE PRODUCT CODE:	87 KWS - prosthesis, shoulder, semi-constrainedmetal/polymer, cemented
SUBSTANTIALLY EQUIVALENT DEVICES:	•DePuy Global Total Shoulder System•Global Total Shoulder with DuPont

·Global Total Shoulder with DuPont Enhanced UHMWPe

DEVICE DESCRIPTION AND INTENDED USE of

DEVICE DESCRIPTION AND INTENDED OOL.
The DePuy Global Shoulder Glenoid is intended use as the glenoid The DePuy Global Shoulder Glenoid is intenced in themel components of the
component in total shoulder arthroplasty, completed using humeral components of the component in total shoulder System. The DePuy Global Shoulder Glenoid is
DePuy Global Total Shoulder System. The DePuy Global Shoulder Glenoid is DePuy Global Total Shoulder System. The Derular Weight Polycht Polychylcuce (UEMWPe).
manufactured in six sizes from Ultra High Molecular Weight Polycht Jobs on the manufactured in sizes from Ultra High Molecular welgis designed to articulate with the head of an existing, commercially available Global Shoulder humeral prosthesis. The head of an existing, commercially available Choual with four pegs, one centrally located fixation (medial) surface is convex and is designed with from pulsion. The centrally located
peg and three peripheral pegs placed in a triangular configuration. The center wh peg and three peripheral pegs placed in a thangular sunner which peg is fitted with radially extending this space realizes provide resistance to provide interdigitation with cement. The unce peripher possible in the prosthetic humeral head.
The man rotational motion caused by translation of the prosthetic humeral hea

BASIS OF SUBSTANTIAL EQUIVALENCE:

BASIS OF SUBSTANTIAL EQUIVALLENCE:
The DePuy Global Should component described in this premarket notification is The DePuy Global Shoulder Glebold computed DePuy Global Shoulder Pegged and Keeled
identical to the currently marketed cemented DePuy Global Shoulder Pegged and Keeled identical to the currently markets centerial (UHMWPe), articular and fixation sufface Glenoid components in terms of material (Univide (United Shoulder arthroplasty,
geometries, and use as the cemented globol Total Shoulder System. geometries, and use as the centented giclisia components of the Shoulder System.
completed using humeral components of the DePuy Global Total Shoulder System.

000006

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 1998

Ms. Sally Foust MB. Saily Fous-DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopedic Drive Warsaw, Indiana 46581-0988

K981487 Re : DePuy Global Shoulder Glenoid Trade Name: Regulatory Class : lı Product Code: KWS April 24, 1998 Dated: April 27, 1998 Received:

Dear Ms. Foust:

We have reviewed your Section 510 (k) notification of intent to we have reviewed your section 310\x7 and we have determined the market the device referenced above and as a indications for device is subscantially equivalent (roz marketed in interestate
use stated in the You 20, 1976 the enactment date of the use stated in the encrosures, to devices that have been commerce prior to may 26, 1978, one ices that have been Medical Device Amendence with the provisions of the Federal reclassified in accordance with the provideciation is based on Food, Drug, and Cosmetic act (act) to similar devices labeled and intended to be fixed with acrylic "bone cement." You may a and intended to be tixed with acty-ro- come general controls
therefore, market your device subject to the general controls therefore, market your device basically ing limitations:

This device may not be labeled or promoted for non-1. cemented use.
All labeling for this device, including package label 2. All labeling torluded within the package, must and fabering incruation "#commently is intended for cemented use only.
Any non-cemented fixation of this device is considered 3. investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for non-21 CFR, Fart oiz. must receive approval from their cemented fixation mional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.

$\beta_i$

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

Page 2 - Ms. Sally Foust

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.

It 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 Requlations, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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.

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

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

Page 3 - Ms. Sally Foust

obtained from the Division of Small Manufacturers Аввівtance 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

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

510(k) Number (if known) K981487

Device Name DePuy Global Shoulder Glenoid

The DePuy Global Shoulder Glenoid is intended for use as a cemented The DePuy Global Shoulder Official is mostes completed using humeral gienoid component in total shoulder System.

The subject device DePuy Global Shoulder Glenoid is part of the Global Total Shoulder System.

Indications for Use:

The humeral components of the Global Total Shoulder System are intended for cemented The humeral components of the Grobal Total Shoulder replacement which is indicated for:

1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis;
1. Fracture-dislocations of the proximal humerus where the articular Fracture-distocations of the prominental separated from blood supply or where surraces are severory connimentional methods of treatment are unsatisfactory:
1. Other difficult clinical management problems where arthrodesis or Other difficult cimical management of a failed primary component).

The glenoid components of the Global Total Shoulder System are intended for cemented use only for the above indications.

Hemi-shoulder replacement is also indicated for:

baid

1. Ununited humeral head fractures of long duration
1. Avascular necrosis of the humeral head

Division Sign Off)
Division of General Restorallye Devices
510(k) Number

29.814 87

Concurrence of CDRH, Office of Device Evaluation

ન્દ્ર Prescription Use

Over-The-Counter Use_No (Per 21 CFR 801.109)

000001

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.”

JUL 13 1998

SUMMARY OF SAFETY AND EFFECTIVENESS

DEVICE DESCRIPTION AND INTENDED USE of

BASIS OF SUBSTANTIAL EQUIVALENCE:

JUL 1 3 1998

Division Sign Off) Division of General Restorallye Devices 510(k) Number

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

Division Sign Off)
Division of General Restorallye Devices
510(k) Number