GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID

K092122 · DePuy Orthopaedics, Inc. · KWS · Jul 27, 2009 · Orthopedic

Device Facts

• Record ID: K092122
• Device Name: GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Jul 27, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The StepTech™ Anchor Peg 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 severely communited, 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). Glenoid components are intended for cemented use only.

Device Story

Glenoid component for total shoulder arthroplasty; manufactured from crosslinked polyethylene. Features backside geometry with step heights (+3, +5, +7 mm) for posterior buildup. Implanted by orthopedic surgeons in clinical settings; requires cement fixation. Provides articular surface for shoulder joint replacement; addresses pain and disability from arthritis or complex fractures. Device serves as a mechanical replacement for damaged glenoid cartilage/bone.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarities to the predicate device.

Technological Characteristics

Material: Crosslinked polyethylene (ASTM F648). Form factor: Glenoid component with posterior buildup step heights (+3, +5, +7 mm). Fixation: Cemented. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total shoulder replacement due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, or proximal humerus fracture-dislocations with severe comminution or vascular compromise. Also indicated for revision of failed primary components or cases where arthrodesis/resection arthroplasty are unacceptable. Contraindicated for non-cemented use.

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 Crosslinked Glenoid (K052472)

Submission Summary (Full Text)

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# JUL 2 7 2009

92122

# Section 6: 510 (k) Summary

(As required by 21 CFR 807.92 and 21 CFR 807.93)

510(K) OWNER:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910

510(K) CONTACT:

Rhonda Myer Senior Regulatory Affairs Associate Telephone: [phone] Facsimile: [phone] Electronic Mail: [e-mail]

DATE PREPARED:

PROPRIETARY NAME:

COMMON NAME:

CLASSIFICATION:

July 8, 2009

DePuy Global Shoulder StepTech" Anchor Peg Glenoid

Shoulder Prosthesis

21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis

DEVICE PRODUCT CODE:

KWS

SUBSTANTIALLY EQUIVALENT DEVICE:

DePuy Global Shoulder Crosslinked Glenoid. K052472 (October 11, 2005)

### DEVICE DESCRIPTION:

The DePuy Global Shoulder StepTech Anchor Peg Glenoid is designed for use as the glenoid component in a total shoulder arthroplasty. The glenoid is manufactured from crosslinked polyethylene conforming to ASTM F648, and is offered in sizes 40, 44, 48, 52 and 56 (bearing diameter and outside profile size) with step heights of +3, +5 and +7 (size of posterior buildup).

DePuy Orthopaedics, Inc.

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## INDICATIONS FOR USE:

The StepTech Anchor Peg 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 severely communited, 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).

Glenoid components are intended for cemented use only.

# BASIS OF SUBSTANTIAL EQUIVALENCE:

The subject Global Shoulder StepTech Anchor Peg Glenoid has the same indications for and intended use, material, sterilization, packaging, and bearing sizes as the previouslycleared DePuy Global Shoulder Crosslinked Glenoids, K052472. The difference between the subject and predicate device is that the subject glenoid has a step in the backside geometry. Because of these similarities, DePuy proposes that the subject of this submission, the Global Shoulder StepTech Anchor Peg Glenoid, is substantially equivalent to the predicate Global Shoulder Crosslinked Glenoid, cleared in K052472 on October 11, 2005.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

DePuy Orthopaedics, Inc. % Ms. Rhonda A. Myer Senior Regulatory Associate, Regulatory Affairs P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

JUL 2 7 2009

Re: K092122

Trade/Device Name: Global Shoulder StepTech Anchor Peg Glenoid Regulation Number: 21 CFR. 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: July 9, 2009 Received: July 14, 2009

Dear Ms. Myer:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle, with its wings spread and head turned to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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#### Page 2 - Ms. Rhonda A. Myer

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Barbara Buell

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section 5: Indications for Use Statement

510 (k) Number (if known): _ 6,092122

Device Name: DePuy Global Shoulder StepTech™ Anchor Peg Glenoid

#### Indications for Use:

The StepTech™ Anchor Peg 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 severely communited, 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).

Glenoid components are intended for cemented use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line. Continue on another page if needed.)

Oputa
(Division Sign-Off)
for nym

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092122

DePuy Orthopaedics, Inc.

Global Shoulder StepTech Anchor Peg Glenoid Special 510(k)

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