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).
Rotator cuff tear arthropathy.

Hemi-shoulder replacement is also indicated for:

Ununited humeral head fractures;
Avascular necrosis of the humeral head.

The Global Fx porous-coated humeral stem is intended for cemented or cementless use with fixation provided by biological tissue in-growth into the porous coating.

Porocoat® Porous-Coated Components
Porocoat® Porous-coated humeral stem prostheses are indicated for cementless use with fixation provided by biological tissue in-growth into the porous coating.

Cemented Components
Humeral stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.

Device Description

The Porous-coated Global Fx humeral stem is a modified Global Fx humeral stem. Porocoat® porous coating has been added to the proximal portion of the stem. The stem is manufactured from cobalt-chromium --molybdenum alloy conforming to ASTM F-75. The stem mates with humeral heads previously cleared as Global Advantage Head (K984541), Global Advantage CTA Heads (K000575) and the Global Advantage Eccentric Humeral Head (K992065).

AI/ML Overview

This 510(k) summary is for a medical device called the "Global™ Fx Porous-Coated Humeral Stem." This document does not describe any acceptance criteria or studies proving the device meets performance criteria, but rather focuses on demonstrating substantial equivalence to a predicate device for marketing clearance.

Therefore, most of the requested information regarding acceptance criteria, device performance, and study details like sample size, ground truth, and expert involvement is not available within the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. The document does not describe performance acceptance criteria for the device itself or report any performance metrics against such criteria. The focus is on demonstrating substantial equivalence to a predicate device, meaning it is considered safe and effective because it is very similar to an already legally marketed device.

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

Not available. There is no test set described for evaluating the device's performance. The review is based on a comparison to a predicate device.

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):

Not available. No ground truth establishment for a test set is mentioned.

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

Not available. No test set or adjudication method is described.

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:

Not applicable. This device is a physical shoulder implant and not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is irrelevant.

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

Not applicable. This device is a physical shoulder implant and not an algorithm.

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

Not available. No ground truth is described as there are no performance studies outlined here. The "ground truth" for regulatory clearance in this context is the predicate device's existing clearance, implying its safety and effectiveness.

8. The sample size for the training set:

Not applicable/Not available. There is no "training set" in the context of this device, which is a physical implant. The substantial equivalence argument relies on engineering analysis and comparison to an existing device, not machine learning model training.

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

Not applicable/Not available. As above, no training set is relevant here.

Summary of Device Comparison for Substantial Equivalence (the main "study" in this document):

Predicate Device: Global Fx Humeral Stem (K984541)
Key Similarity: Both humeral stems have identical locking tapers, are tapered in design, come in similar sizes, and are manufactured from the same materials (cobalt-chromium-molybdenum alloy conforming to ASTM F-75).
Key Difference (and reason for this 510(k)): The addition of Porocoat® porous coating to the proximal portion of the new Global™ Fx Porous-Coated Humeral Stem.
Outcome: The FDA found the device "substantially equivalent" to the predicate device, allowing it to be marketed. This decision is based on the similarities described and the understanding that the addition of porous coating for biological tissue in-growth (rather than cementless use) is well-understood and fits within the regulatory framework for similar devices.

Summary

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JUL - 6 2001

K011099

510(k) Summary

Name of Sponsor:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Est. Reg. No. 1818910
510(k) Contact:	Marcia J. ArentzSenior Regulatory AssociatePhone: (219) 371-4944FAX: (219) 371-4987
Trade Name:	Global™ Fx Porous-Coated Humeral Stem
Common Name:	Shoulder prosthesis, humeral head
Classification:	Class II (special controls) per 21 CFR 888.3670Shoulder joint metal/polymer/metal non-constrained orsemi-constrained porous-coated uncemented prosthesis.
	Class II (special controls) per 21 CFR 888.3660Shoulder joint metal/polymer semi-constrainedcemented prosthesis.
Device Product Code:	Code: 87 MBF Prosthesis, Shoulder, semi-constrained, metal/polymer, Uncemented.Code: 87 KWS Prosthesis, Shoulder, Semi-con-strained, metal/polymer Cemented.
Substantially Equivalent Devices:	Global Fx Shoulder SystemK984541Porous Coated Global ShoulderK943300
Device Description:	The Porous-coated Global Fx humeral stem is amodified Global Fx humeral stem. Porocoat® porouscoating has been added to the proximal portion of thestem. The stem is manufactured from cobalt-chromium --molybdenum alloy conforming to ASTMF-75. The stem mates with humeral heads previouslycleared as Global Advantage Head (K984541),Global Advantage CTA Heads (K000575) and theGlobal Advantage Eccentric Humeral Head(K992065).
Intended use:	The Global Fx Porous-coated humeral stem, incombination with Global shoulder humeral heads, isintended for use in total or hemi-arthroplasty.
Indications for use:	Total or hemi-shoulder replacement is indicated for:
	1. A severely painful and/or disabled joint resultingfrom osteoarthritis, traumatic arthritis or rheumatoidarthritis;

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Fracture-dislocations of the proximal humerus. 2. 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 3. or resection arthroplasty are not arthrodesis acceptable (e.g., revision of a failed primary component).

Rotator cuff tear arthropathy. 4.

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures;
  Avascular necrosis of the humeral head. 2.

The Global Fx porous-coated humeral stem is intended for cemented or cementless use with fixation provided by biological tissue in-growth into the porous coating.

Substantial equivalence:

The Global Advantage Extended Humeral Head is substantially equivalent to the Global Fx Humeral Stem cleared in K984541. Both humeral stems have identical locking tapers, are tapered in design, come in similar sizes and are manufactured from the same materials. The only difference between the two stems is the addition of porous coating to the proximal portion of the stem.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human face in profile, with three curved lines representing the hair or head.

JUL - 6 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K011099

Trade Name: Global™ Fx Porous-Coated Humeral Stem Regulation Number: 888.3670 and 888.3660 Regulatory Class: II Product Code: MBF and KWS Dated: April 10, 2001 Received: April 11, 2001

Dear Ms. Arentz:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have have determined the device is substantially equivalent (for the indications for use above and we nave actering in interstate commerce prior to May 28, 1976, the stated in the oneroune) to were amendments, or to devices that have been reclassified in oncentions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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, listing of devices, cond 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 ( remainer ripple any 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 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

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

Page 2 - Ms. Marcia J. Arentz

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 If you desire specific advice for your do rices), please contact the Office of Compliance at additionally 809.10 for in This diagnotions on the promotion and advertising of your device, (301) 394-4639. Addinonally, for questions on (301) 594-4639. Also, please note the regulation please comact the Orifice or Compilance at (2017) of the Station" (21 CFR 807.97). Other general entitled, TMIsoraliumly by releveles to pearler to act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained from 11, miorination on your responsionates and in more (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

thlulln
S.M. White, Ph.D., M.D.

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

Enclosure

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510(k) Number (if known): Κοι/ο 99

Device Name: Global™ Fx Porous-Coated Humeral Stem

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 Fracture chooseneed 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).
1. Rotator cuff tear arthropathy.

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures;
1. Avascular necrosis of the humeral head.

Porocoat® Porous-Coated Components

I orocoal " orous-coated humeral stem prostheses are indicated for cementless use with fixation provided by biological tissue in-growth into the porous coating.

Cemented Components

Humeral stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(Pcr 21 CFR/801.109)

Over-The-Counter Use

No
comiraveto orcm

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K011097

Regulation Number and Section

§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement 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 (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”