DEPUY GLOBAL AP CTA HUMERAL HEAD

• K Number: K082715
• Device Name: DEPUY GLOBAL AP CTA HUMERAL HEAD
• Manufacturer: DEPUY ORTHOPAEDICS, INC.
• Date Cleared: 2008-12-18 ( 92 days)
• Product Code: HSD , IIS , MET
• Regulation Number: 888.3690
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K000575
• Predicate For: K110706 , K203230

Intended Use

The Global AP CTA Humeral Head, in combination with a Global AP Shoulder humeral stem, is intended for use in hemi-shoulder arthroplasty.

Hemi-shoulder replacement is indicated for:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
2. 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;
3. 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.
2. Avascular necrosis of the humeral head.
3. Rotator cuff tear arthropathy.
4. Deformity and/or limited motion.

Un-coated Global AP Humeral Stems are indicated for cemented use only. Global AP Humeral Stems with Porocoat® are indicated for cemented or cementless use.

Device Description

The Global AP CTA Humeral Head, in combination with a Global AP Shoulder humeral stem, is intended for use in hemi-shoulder arthroplasty.

AI/ML Overview

The provided document is a 510(k) summary for the DePuy Global AP CTA Humeral Head, a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific performance criteria through a study in the same way a new drug or novel medical device might. Therefore, the information you're requesting regarding acceptance criteria and a study proving those criteria are met is not typically found or required in a 510(k) submission for a device of this nature.

510(k) clearances, especially for devices like orthopedic implants that are often based on existing designs and materials, focus on comparing the new device to a predicate device in terms of:

• Intended Use and Indications: Ensuring they are the same or similar.
• Design and Materials: Verifying similar principles, materials, and construction.
• Performance (Bench Testing): Often involves mechanical and material testing to ensure safety and function equivalent to the predicate, rather than clinical efficacy studies.
• Manufacturing and Sterilization: Demonstrating processes are consistent and appropriate.

Based on the provided document, here's what can be extracted/inferred regarding your questions:

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

   • Not Applicable (N/A). The 510(k) emphasizes substantial equivalence to the predicate device (DePuy Global Advantage Extended Head, K000575) based on similarities in intended use, indications for use, materials, design, method of manufacture, sterilization, and packaging. There are no specific "acceptance criteria" and "reported device performance" in the clinical or AI-assisted sense found in this document. Any performance testing would be standard mechanical/material testing for orthopedic implants, demonstrating equivalence to the predicate, rather than clinical efficacy metrics.

2. Sample size used for the test set and the data provenance:

   • N/A. This document does not describe a "test set" in the context of a clinical study or AI model evaluation. It's a regulatory submission for a physical medical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. Not relevant for this type of medical device submission. Ground truth establishment is not part of this 510(k) process.

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

   • N/A. Not relevant.

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:

   • N/A. This is not an AI-powered device.

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

   • N/A. This is not an AI-powered device.

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

   • N/A. There isn't a "ground truth" in the context of clinical endpoints for the humeral head device as presented here. Substantial equivalence relies on comparison to a predicate, not establishing novel clinical efficacy against a "ground truth."

8. The sample size for the training set:

   • N/A. There is no "training set" as this is not an AI/machine learning device.

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

   • N/A. Not applicable.

Summary of what the document does address for proving device safety and effectiveness (via substantial equivalence):

The device is considered substantially equivalent to the DePuy Global Advantage Extended Head (K000575) because they share:

• Intended Use: Hemi-shoulder arthroplasty.
• Indications for Use: (listed in detail in the document, covering various conditions like osteoarthritis, fractures, avascular necrosis, etc.).
• Materials: Implied to be similar to the predicate.
• Design: Implied to be similar to the predicate.
• Method of Manufacture: Implied to be similar.
• Sterilization and Packaging Methods: Implied to be similar.

In essence, for this type of medical device 510(k), the "study that proves the device meets the acceptance criteria" is the comprehensive comparison demonstrating its equivalence to a device already legally on the market. Clinical trials demonstrating novel safety and efficacy are generally reserved for PMA (Pre-Market Approval) devices or devices with novel technology where substantial equivalence cannot be established.

Summary

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

K082715

p. 1/2

DEC 1 8 2008

510 (k) Summary

(As required by 21 CFR 807.92 and 21 CFR 807.93)

NAME OF SPONSOR:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910

MANUFACTURER:

510(K) CONTACT:

PROPRIETARY NAME:

COMMON NAME:

CLASSIFICATION:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910

Rhonda Myer Regulatory Affairs Associate Telephone: [phone] Facsimile: [phone] Electronic Mail: [e-mail]

DePuy Global AP CTA Humeral Head

Shoulder Prosthesis, Humeral Head

Class II device per 21 CFR §888.3690: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (HSD)

87 HSD Prosthesis, Shoulder, Hemi-, Humeral,

DEVICE PRODUCT CODE:

Metallic Uncemented

SUBSTANTIALLY EQUIVALENT DEVICE:

DePuy Global Advantage Extended Head, K000575

DEVICE DESCRIPTION:

The Global AP CTA Humeral Head, in combination with a Global AP Shoulder humeral stem, is intended for use in hemi-shoulder arthroplasty.

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

082715

p.2/2

INDICATIONS AND INTENDED USE:

Indications:

The Global AP CTA Humeral Head, used with a Global AP Humeral Stem, is indicated for use in hemi-shoulder replacement.

Hemi-shoulder replacement is indicated for:

• 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
• 2. 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;
• 3. 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.
• 2. Avascular necrosis of the humeral head.
• 3. Rotator cuff tear arthropathy.
• 4. Deformity and/or limited motion.

Un-coated Global AP Humeral Stems are indicated for cemented use only. Global AP Humeral Stems with Porocoal® are indicated for cemented or cementless use.

Intended Use:

The Global AP CTA Humeral Head, in combination with a Global AP Shoulder humeral stem, is intended for use in hemi-shoulder arthroplasty.

BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on the similarities in intended use, indications for use, materials, design, method of manufacture, sterilization and packaging methods, DePuy believes the subject Global AP CTA Humeral Head is substantially equivalent to the previously cleared Global Advantage Extended Head, K000575.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2008

DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Senior Regulatory Affairs Associate 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46582

Re: K082715

Trade/Devicc Namc: DePuy Global AP CTA Head Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: IISD Dated: December 3, 2008 Received: December 4, 2008

Dear Ms. Myer:

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 (PMA). You may. therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, fisting 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 (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 801); 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.

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

Page 2 – Ms. Rhonda Myer

This letter will allow you to begin marketing your device as described in your Section 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, permitts your cevice to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly yours,

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K082715

Indications for Use Statement

510 (k) Number (if known): K082715

Device Name: DePuy Global AP CTA Head

Indications for Use:

The Global AP CTA Humeral Head, used with a Global AP Humeral Stem, is indicated for use in hemi-shoulder replacement.

Hemi-shoulder replacement is indicated for:

• 1. A severely painful and/or disabled joint resulting from osteoarthritis. traumatic arthritis or rheumatoid arthritis;
• 2. 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;
• 3. 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.
• 2. Avascular necrosis of the humeral head.
• 3. Rotator cuff tear arthropathy.
• 4. Deformity and/or limited motion.

Un-coated Global AP Humeral Stems are indicated for cemented use only. Global AP Humeral Stems with Porocoat® are indicated for cemented or cementless use.

Prescription Use	X(Part 21 CFR 801 Subpart D)
	AND/OR
Over-The-Counter Use	(21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 12, 2003) (Division Sign-Off) Des Dir Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number	L082718
---------------	---------

DePuy Orthopaedics, Inc.

K082715 Global AP CTA Humeral Head

Regulation Number and Section

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.