DEPUY GLOBAL SHOULDER CROSSLINK GLENOID

K052472 · DePuy Orthopaedics, Inc. · KWS · Oct 6, 2005 · Orthopedic

Device Facts

• Record ID: K052472
• Device Name: DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Oct 6, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Crosslink Glenoids are intended for use in total shoulder replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, nost-traumatic arthritis, trauma or failed prior surgical intervention. The Crosslink Glenoids are intended for cemented use only.

Device Story

Shoulder prosthesis component; glenoid implant for total shoulder arthroplasty. Available in anchor peg and fin designs; concave lateral surface articulates with DePuy Global humeral heads. Implanted into glenoid fossa of scapula using bone cement. Manufactured from highly cross-linked polyethylene to reduce wear compared to standard polyethylene. Used by orthopedic surgeons in clinical/hospital settings to restore joint function and alleviate pain in patients with severe structural shoulder damage.

Clinical Evidence

Bench testing only. Shoulder simulator wear studies conducted to compare wear rates of highly cross-linked polyethylene against predicate Enduron polyethylene.

Technological Characteristics

Highly cross-linked polyethylene glenoid component. Anchor peg or fin fixation designs. Cemented fixation. Semi-constrained metal/polymer prosthesis.

Indications for Use

Indicated for patients with severe pain/disability due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, proximal humerus fracture-dislocations with compromised blood supply, or failed prior surgical intervention where arthrodesis/resection is unacceptable. For cemented use only.

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™ Shoulder Glenoid (K981487)
• DePuy Global™ Shoulder (K914000)
• DePuy Sigma XLK Tibial Inserts (K040166)

Submission Summary (Full Text)

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# OCT 6 - 2005

## SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Orthopaedics, Inc.<br>P.O. Box 988<br>709 Orthopaedic Drive<br>Warsaw, IN 46581-0988 |
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| 510(k) CONTACT: | Natalie Heck<br>Manager, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone] |
| TRADE NAME: | DePuy Global™ Shoulder Crosslink Glenoid |
| COMMON NAME: | Shoulder Prosthesis |
| CLASSIFICATION: | 888.3660 Shoulder joint metal/polymer semi-<br>constrained cemented prosthesis; Class II |
| DEVICE PRODUCT CODE: | KWS |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | DePuy Global™ Shoulder Glenoid - K981487<br>DePuy Global™ Shoulder - K914000<br>DePuy Sigma XLK Tibal Inserts - K040166 |

### DEVICE DESCRIPTION:

The DePuy Global™ Crosslink Glenoids are offered in an anchor peg and a fin design. The Crosslink Glenoid anchor peg design consists of sizes: 40mm, 48mm, 48mm, 52mm, 56mm and 56mmXL. The Crosslink Glenoid in the fin design consists of seven sizes: 40mmXS, 40mm, 44mm, 52mm, 52mm, 56mm and 56mmXL. Both the anchor peg and fin designs have a lateral surface that is concave and designed to articulate with the DePuy Global™ line humeral heads indicated for ase in total shoulder arthroplasty. The fixation surface has a central fin or peripheral pegs and is intended to be attached to the glenoid fossa of the scapula with bone cement.

#### INTENDED USE:

The Crosslink Glenoids are intended for use in total shoulder replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, nost-traumatic arthritis, trauma or failed prior surgical intervention.

The Crosslink Glenoids are intended for cemented use only.

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#### BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Global™ Crosslink Glenoids have the same design, intended use and indications as the Glenoid components cleared in K981497 and K914000 as part of DePuy's Global Shoulder System. The difference between the Crosslink Glenoids proposed in this submission and the Glenoids in the Global Shoulder System is the type of polyethylene used to manufacture the components. The Crosslink Glenoids are made from highly cross-linked polyethylene, which has been to shown to have a reduction in wear compared to currently available Enduron polyethylene. The Crosslink Glenoids are made from the same cross-linked polyethylene as that cleared in the DePuy Sigma XI.K. Tibial Inserts, listed in K040166. Due to the similarities noted DePuy believes the Crosslink Glenoids to be substantially equivalent in design to the Glenoids of DePuv Global Shoulder System and in material to the DePuy Sigma XLK Tibial Inserts, with the additional claim of reduced wear, based on results of shoulder simulator wear studies of these devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized human figure with three wavy lines representing the body. The figure is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter.

OCT 6 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K052472

Trade/Device Name: DePuy Global™ Shoulder Crosslink Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: September 3, 2005 Received: September 8, 2005

Dear Ms. Heck:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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, 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Mellon

Co Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): _K 02472

Device Name: DePuy Global™ Shoulder Crosslink Glenoid

Indications for Use:

The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

- 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 Fracture ansiountine , separated from its blood supply or where the surgeon's severience 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).

Glenoid components are intended for cemented use only.

| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|-----------------------------|---|--------|------------------------|--|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 807 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

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| 510(k) Number | K052472 | 0000005 |
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