GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD

K984541 · DePuy Orthopaedics, Inc. · KWT · Jan 14, 1999 · Orthopedic

Device Facts

• Record ID: K984541
• Device Name: GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWT · Orthopedic
• Decision Date: Jan 14, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3650
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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).

Device Story

Global Shoulder system (humeral stem and head) provides prosthetic replacement for shoulder joint. Components feature modular morse-type taper lock; humeral head (male) mates with humeral body (female). Designed for total or hemiarthroplasty; humeral stem supports cemented or press-fit fixation. Modifications include reduced A/P and M/L dimensions for smaller metaphyses/fracture cases; lateral fin profile reduced to avoid biceps tendon contact/varus tilting; medial fin includes suture hole for tuberosity repositioning; collar/head interface modified with recess to reduce gap and increase articular surface area. Used by orthopedic surgeons in clinical settings to restore joint biomechanics and alleviate pain in patients with arthritis, fractures, or necrosis.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design control procedures, material analysis, and comparison of technological characteristics to predicate devices.

Technological Characteristics

Modular humeral prosthesis; Co-Cr-Mo alloy (F-75). Features: proximal fins, proximal collar, fluted distal stem, morse-type taper lock. Dimensions modified for smaller metaphyses. Fixation: press-fit or cemented. Sterilization: standard methods implied. 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 vascular compromise; or other conditions where arthrodesis/resection are unacceptable (e.g., revision). Hemi-shoulder replacement also indicated for ununited humeral head fractures and avascular necrosis.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Global Shoulder (K911686)
• Global Shoulder (K914695)

Reference Devices

• Global cemented glenoid components (K905786)
• Global cemented glenoid components (K914000)
• HRP Shoulder

Submission Summary (Full Text)

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K98454/

JAN 1 4 1999

### Summary of Safety and Effectiveness

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Est. Reg. No. 1818910 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Arlene C. Saull, RAC<br>Sr. Regulatory Associate<br>Phone: [phone]<br>FAX: [phone]<br>E-Mail: [e-mail] |
| TRADE NAME: | Global™ Shoulder<br>● Global™ Fx Humeral Stem<br>● 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 §888.3690<br>When 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)<br>87 KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (Class III) |
| SUBSTANTIALLY EQUIVALENT DEVICE: | Global Shoulder: K911686, K914695 |

# 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.

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### Summary of Safety and Effectiveness (Continued)

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.
- 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 . . . . .

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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;
- 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.

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.

#### 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 . . . . .

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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.

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#### 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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;
- 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.

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.

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

OR

Over-The-Counter Use

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