DEPUY GLOBAL SHOULDER GLENOID

K981487 · DePuy Orthopaedics, Inc. · KWS · Jul 13, 1998 · Orthopedic

Device Facts

• Record ID: K981487
• Device Name: DEPUY GLOBAL SHOULDER GLENOID
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Jul 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The DePuy Global Shoulder Glenoid is intended for use as a cemented glenoid component in total shoulder arthroplasty, completed using humeral components of the DePuy Global Total Shoulder System.

Device Story

The DePuy Global Shoulder Glenoid is a prosthetic component for total shoulder arthroplasty. It is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPe). The device features a convex articular surface designed to articulate with a commercially available Global Shoulder humeral prosthesis. Fixation is achieved via four pegs: one central peg and three peripheral pegs in a triangular configuration, which provide interdigitation with bone cement. The device is intended for use by orthopedic surgeons in a clinical/surgical setting. It is strictly indicated for cemented fixation; non-cemented use is considered investigational. The device aims to restore joint function and reduce pain in patients with severe shoulder joint pathology.

Technological Characteristics

Material: Ultra High Molecular Weight Polyethylene (UHMWPe). Design: Glenoid component with four-peg fixation (one central, three peripheral). Fixation: Cemented. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring cemented total shoulder replacement due to severely painful/disabled joints from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; fracture-dislocations of the proximal humerus with compromised blood supply or failed conventional treatment; or other difficult clinical management problems (e.g., revision of failed primary component). Hemi-shoulder replacement is indicated for ununited humeral head fractures of long duration 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 System
• Global Total Shoulder with DuPont Enhanced UHMWPe

Submission Summary (Full Text)

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### JUL 13 1998

# SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy, Inc.<br>P.O. Box 988<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| FIRM CONTACT: | Sally Foust<br>Regulatory Submissions Associate<br>[phone]; FAX [phone]<br>E-Mail: [e-mail] |
| TRADE NAME: | DePuy Global Shoulder Glenoid |
| COMMON NAME: | Shoulder Prosthesis |
| DEVICE PRODUCT CODE: | 87 KWS - prosthesis, shoulder, semi-constrained<br>metal/polymer, cemented |
| SUBSTANTIALLY EQUIVALENT DEVICES: | •DePuy Global Total Shoulder System<br>•Global Total Shoulder with DuPont |

·Global Total Shoulder with DuPont Enhanced UHMWPe

# DEVICE DESCRIPTION AND INTENDED USE of

DEVICE DESCRIPTION AND INTENDED OOL.
The DePuy Global Shoulder Glenoid is intended use as the glenoid The DePuy Global Shoulder Glenoid is intenced in themel components of the
component in total shoulder arthroplasty, completed using humeral components of the component in total shoulder System. The DePuy Global Shoulder Glenoid is
DePuy Global Total Shoulder System. The DePuy Global Shoulder Glenoid is DePuy Global Total Shoulder System. The Derular Weight Polycht Polychylcuce (UEMWPe).
manufactured in six sizes from Ultra High Molecular Weight Polycht Jobs on the manufactured in sizes from Ultra High Molecular welgis designed to articulate with the head of an existing, commercially available Global Shoulder humeral prosthesis. The head of an existing, commercially available Choual with four pegs, one centrally located fixation (medial) surface is convex and is designed with from pulsion. The centrally located
peg and three peripheral pegs placed in a triangular configuration. The center wh peg and three peripheral pegs placed in a thangular sunner which peg is fitted with radially extending this space realizes provide resistance to provide interdigitation with cement. The unce peripher possible in the prosthetic humeral head.
The man rotational motion caused by translation of the prosthetic humeral hea

## BASIS OF SUBSTANTIAL EQUIVALENCE:

BASIS OF SUBSTANTIAL EQUIVALLENCE:
The DePuy Global Should component described in this premarket notification is The DePuy Global Shoulder Glebold computed DePuy Global Shoulder Pegged and Keeled
identical to the currently marketed cemented DePuy Global Shoulder Pegged and Keeled identical to the currently markets centerial (UHMWPe), articular and fixation sufface Glenoid components in terms of material (Univide (United Shoulder arthroplasty,
geometries, and use as the cemented globol Total Shoulder System. geometries, and use as the centented giclisia components of the Shoulder System.
completed using humeral components of the DePuy Global Total Shoulder System.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### JUL 1 3 1998

Ms. Sally Foust MB. Saily Fous-DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopedic Drive Warsaw, Indiana 46581-0988

K981487 Re : DePuy Global Shoulder Glenoid Trade Name: Regulatory Class : lı Product Code: KWS April 24, 1998 Dated: April 27, 1998 Received:

Dear Ms. Foust:

We have reviewed your Section 510 (k) notification of intent to we have reviewed your section 310\x7 and we have determined the market the device referenced above and as a indications for device is subscantially equivalent (roz marketed in interestate
use stated in the You 20, 1976 the enactment date of the use stated in the encrosures, to devices that have been commerce prior to may 26, 1978, one ices that have been Medical Device Amendence with the provisions of the Federal reclassified in accordance with the provideciation is based on Food, Drug, and Cosmetic act (act) to similar devices labeled and intended to be fixed with acrylic "bone cement." You may a and intended to be tixed with acty-ro- come general controls
therefore, market your device subject to the general controls therefore, market your device basically ing limitations:

- This device may not be labeled or promoted for non-1. cemented use.
- All labeling for this device, including package label 2. All labeling torluded within the package, must and fabering incruation "#commently is intended for cemented use only.
- Any non-cemented fixation of this device is considered 3. 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 device for non-21 CFR, Fart oiz. must receive approval from their cemented fixation mional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.

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Page 2 - Ms. Sally Foust

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

It 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 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 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

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Page 3 - Ms. Sally Foust

obtained from the Division of Small Manufacturers Аввівtance 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

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Enclosure

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510(k) Number (if known) K981487

Device Name DePuy Global Shoulder Glenoid

The DePuy Global Shoulder Glenoid is intended for use as a cemented The DePuy Global Shoulder Official is mostes completed using humeral gienoid component in total shoulder System.

The subject device DePuy Global Shoulder Glenoid is part of the Global Total Shoulder System.

Indications for Use:

The humeral components of the Global Total Shoulder System are intended for cemented The humeral components of the Grobal Total 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 Fracture-distocations of the prominental separated from blood supply or where surraces are severory connimentional methods of treatment are unsatisfactory:
- 3. Other difficult clinical management problems where arthrodesis or Other difficult cimical management of a failed primary component).

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

Hemi-shoulder replacement is also indicated for:

baid

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

Division Sign Off)
Division of General Restorallye Devices
510(k) Number
-
29.814 87

Concurrence of CDRH, Office of Device Evaluation

OR

ન્દ્ર Prescription Use

Over-The-Counter Use_No (Per 21 CFR 801.109)

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