GLOBAL FX POROUS-COATED HUMERAL STEM

K011099 · DePuy Orthopaedics, Inc. · MBF · Jul 6, 2001 · Orthopedic

Device Facts

• Record ID: K011099
• Device Name: GLOBAL FX POROUS-COATED HUMERAL STEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: MBF · Orthopedic
• Decision Date: Jul 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Global Fx Porous-coated humeral stem, in combination with Global shoulder humeral heads, is intended for use in total or hemi-arthroplasty.

Device Story

Global Fx Porous-Coated Humeral Stem is a shoulder prosthesis component for total or hemi-arthroplasty. Device consists of a cobalt-chromium-molybdenum alloy stem with a proximal Porocoat® porous coating to facilitate biological tissue in-growth for cementless fixation; also compatible with cemented use. Stem mates with previously cleared Global Advantage humeral heads. Used by orthopedic surgeons in clinical settings for patients with severe joint pain, arthritis, fractures, or necrosis. Device provides structural replacement of the humeral head, restoring joint function and reducing pain. No software or algorithmic components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cobalt-chromium-molybdenum alloy (ASTM F-75). Porous-coated proximal stem for biological tissue in-growth. Tapered design with locking taper interface for humeral head attachment. Intended for cemented or cementless use. No software or electronic components.

Indications for Use

Indicated for patients with severely painful/disabled joints due to osteoarthritis, traumatic arthritis, or rheumatoid arthritis; proximal humerus fracture-dislocations with severe comminution or compromised blood supply; difficult clinical problems where arthrodesis/resection arthroplasty are unacceptable (e.g., revision); and rotator cuff tear arthropathy. Hemi-shoulder replacement also indicated for ununited humeral head fractures and avascular necrosis. Porous-coated components indicated for cementless use (biological tissue in-growth); components labeled 'For cemented use only' indicated for use with bone cement.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Global Fx Shoulder System (K984541)
• Porous Coated Global Shoulder (K943300)

Reference Devices

• Global Advantage Head (K984541)
• Global Advantage CTA Heads (K000575)
• Global Advantage Eccentric Humeral Head (K992065)

Submission Summary (Full Text)

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JUL - 6 2001

K011099

# 510(k) Summary

| Name of Sponsor: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Est. Reg. No. 1818910 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Marcia J. Arentz<br>Senior Regulatory Associate<br>Phone: [phone]<br>FAX: [phone] |
| Trade Name: | Global™ Fx Porous-Coated Humeral Stem |
| Common Name: | Shoulder prosthesis, humeral head |
| Classification: | Class II (special controls) per 21 CFR 888.3670<br>Shoulder joint metal/polymer/metal non-constrained or<br>semi-constrained porous-coated uncemented prosthesis. |
| | Class II (special controls) per 21 CFR 888.3660<br>Shoulder joint metal/polymer semi-constrained<br>cemented prosthesis. |
| Device Product Code: | Code: 87 MBF Prosthesis, Shoulder, semi-constrained, metal/polymer, Uncemented.<br>Code: 87 KWS Prosthesis, Shoulder, Semi-con-strained, metal/polymer Cemented. |
| Substantially Equivalent Devices: | Global Fx Shoulder System<br>K984541<br>Porous Coated Global Shoulder<br>K943300 |
| Device Description: | The Porous-coated Global Fx humeral stem is a<br>modified Global Fx humeral stem. Porocoat® porous<br>coating has been added to the proximal portion of the<br>stem. The stem is manufactured from cobalt-<br>chromium --molybdenum alloy conforming to ASTM<br>F-75. The stem mates with humeral heads previously<br>cleared as Global Advantage Head (K984541),<br>Global Advantage CTA Heads (K000575) and the<br>Global Advantage Eccentric Humeral Head<br>(K992065). |
| Intended use: | The Global Fx Porous-coated humeral stem, in<br>combination with Global shoulder humeral heads, is<br>intended 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 resulting<br>from osteoarthritis, traumatic arthritis or rheumatoid<br>arthritis; |

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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

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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, [phone]. Addinonally, for questions on [phone]. 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 [phone] or at [phone], 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;
- 2. 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;
- 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).
- 4. Rotator cuff tear arthropathy.

Hemi-shoulder replacement is also indicated for:

- 1. Ununited humeral head fractures;
- 2. 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)

OR

Over-The-Counter Use

No
comiraveto orcm

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

510(k) Number K011097