GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD

K974044 · DePuy Orthopaedics, Inc. · KWS · Jan 22, 1998 · Orthopedic

Device Facts

• Record ID: K974044
• Device Name: GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The humeral components of the Global Total Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement which is indicated for: 1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; 2. Fracture-dislocations of the proximal humerus where the articular surfaces are severely comminuted, separated from blood supply or where experience shows more conventional methods of treatment are unsatisfactory; 3. Other difficult clinical management problems where arthrodesis or resection are not acceptable (i.e., revision of a failed primary component). The glenoid components of the Global Total Shoulder are intended for cemented use only for the above indications. Hemi-shoulder replacement is also indicated for: 1. Ununited humeral head fractures of long duration; 2. Avascular necrosis of the humeral head.

Device Story

The Global Total Shoulder Eccentric Humeral Head is a prosthetic component for total or hemi-shoulder replacement. It features a male taper shifted 4.0mm off-center, allowing surgeons to 'dial' the head position for improved anatomical alignment on the proximal humerus. It is designed for use with existing DePuy Global Total Shoulder humeral bodies and glenoid components. The device is implanted by orthopedic surgeons in a clinical/surgical setting. By providing an offset option, the device enables better coverage of the cut surface of the proximal humerus, potentially improving joint stability and function for patients suffering from severe arthritis, fractures, or necrosis.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and geometric similarity to the predicate device.

Technological Characteristics

Material: Co-Cr-Mo alloy. Design: Humeral head prosthesis with 4.0mm eccentric male taper offset. Connectivity: None (mechanical implant). Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients with severe joint pain/disability due to osteoarthritis, traumatic arthritis, or rheumatoid arthritis; proximal humerus fracture-dislocations with severe comminution or vascular compromise; revision of failed primary components; ununited humeral head fractures; or avascular necrosis of the humeral head.

Regulatory Classification

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).

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 “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.”

Predicate Devices

• DePuy Global™ Total Shoulder (standard) Humeral Head

Submission Summary (Full Text)

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CLINKEGLOS

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

EXHIBIT DePuy, Inc. NAME OF FIRM: 700 Orthopaedic Drive JAN 22 1998 Warsaw, Indiana 46581-0988 510(K) CONTACT: Arlene C. Saull, RAC Sr. Submissions Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581-0988 Global™ Total Shoulder Eccentric Humeral Head TRADE NAME: Total Shoulder Prosthesis, or Hemi-Shoulder Prosthesis COMMON NAME: Class III. when used as a total shoulder per 21 CFR, CLASSIFICATION: Shoulder joint metal/polymer semi-constrained 888.3660: cemented prosthesis. Class II, when used as a hemi-shoulder per 21 CFR, 888.3690. Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. Shoulder, Semi-Constrained KWS: Prosthesis, DEVICE PRODUCT CODE: 87 Metal/Polymer, Cemented (Class III) 87 HSD Prosthesis, Hemi-Shoulder, Humeral, Metallic Uncemented (Class II) SUBSTANTIALLY DePuy Global™ Total Shoulder EQUIVALENT DEVICES: DePuy Global™ Total Shoulder, Humeral Component, for

Cemented or Uncemented Use

#### DEVICE DESCRIPTION AND INTENDED USE:

The DePuy Global Total Shoulder Eccentric Humeral Head will be available in a variety of sizes which are designed with offset male tapers to be used with the currently marketed DePuy Global Total Shoulder Humeral Bodies and Glenoid Components. The male taper on the Global Total Shoulder Eccentric Humaral Head is shifted 4.0mm off the head center. This offset permits the head to be "dialed" to cover the cut surface of the proximal humerus. This allows placement of the head in a more anatornically aligned position.

The humeral components of the Global Total Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement which is indicated for:

1 is ge 1 al 2

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

- A severely paintul and/or a severely disabled joint resulting from osteoarthritis, traumatic 】. arthritis, or rhewnatoid arthritis;
- Fracture-dislocations of the proximal humerus where the articular surfaces are severely 2. comminuted, separated from blood supply or where experience shows more conventional methods of treatment are unsatisfactory;
- 3. Other difficult :) incal management problems where arthrodesis or resection are not acceptable (i.e., revision of a failed primary component).

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

Hemi-shoulder replacement is also indicated for:

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

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The subject Global Total Shoulder Eccentric Humeral Heads are identical in design to the predicate Global Total Shoulder (:: andard) Humeral Head with the exception that the male taper is offsel 4.0mm.

The subject Global Total Shoulder Eccentric Humeral Heads are designed to be used with the same humeral bodies and glenvid components as the predicate standard humeral heads. The geometry of the articular surface of the subject eccentric humeral head is identical to that of the predicate standard concentric humeral head, thus the contact area will remain the same.

The subject Global Total Shoulder Eccentric Humeral Head is similar in material, sizes, intended use, and design to the predicate Global Total Shoulder (standard) Humeral Heads, with the exception of the eccentricity (offset) of the male taper of the subject device versus the concentricity of the male taper of the predicate device.

The indications for use are the same for both and they replace the same anatomic structures. Also, the Co-Cr-Mo alloy material of the subject eccentric humeral head is the same as that used for the predicate device.

Based on the information provided in this premarket notification DePuy considers the Global Total Shoulder Eccentric Humeral Head to be substantially equivalent to the predicate Global Total Shoulder (standard) Humoral Head currently marketed.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 1998

Arlene C. Saull, RAC Senior Submissions Associate DePuy Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

K974044 Re: Global™ Total Shoulder Eccentric Humeral Head Requlatory Class: III Product Codes: KWS and HSD Dated: October-23, 1997 ---Received: October 24, 1997

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). This decision is based on the humeral component being used as a cemented or uncemented humeral hemi-shoulder, or as the cemented or uncemented humeral component of a total shoulder system which has a cemented glenoid component. You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

- The glenoid component of the Global Total Shoulder may " 1. not be labeled or promoted for non-cemented use.
- All labeling for this device, including package label 2. and labeling included within the package, must prominently state that the glenoid component is intended for cemented use only.

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### Page 2 - Arlene C. Saull, RAC

- Any non-cemented fixation of the glenoid component of 3. this device is considered 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 glenoid component for non-cemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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 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 General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation 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 Requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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

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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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## INDICATIONS

510(k) Number (if known)

Device Name Global Total Shoulder

The subject device Global Shoulder Eccentric Humeral Head is part of the Global Total Shoulder System.

Indications for Use:

The humeral components of the Global Total Shoulder are intended for cementless use as a total or hemi-shoulder replacement which is indicated for:

- 1. A severely painful und/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis:
- 2. Fracture-dislocations of the proximal humerus where the articular surfaces are severely comminuted, separated from blood supply or where experience shows more conventional methods of treatment are unsatisfactory:
- 3. Other difficult clinical management problems where arthrodesis or resection are not acceptable (i.e., revision of a failed primary component).

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

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures of long duration;

2. Avascular necrosis of the humeral head.

Concurrence of CDRH, Office of Device Evaluation:

OR

\$\infty\$

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K974044

Prescription Use

Over-The Counter Use __ (Per 21 CFR 801.109)