ARTHREX UNIVERS II SHOULDER PROSTHESIS

K071032 · Arthrex, Inc. · KWS · Aug 20, 2007 · Orthopedic

Device Facts

• Record ID: K071032
• Device Name: ARTHREX UNIVERS II SHOULDER PROSTHESIS
• Applicant: Arthrex, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Aug 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.

Device Story

Shoulder prosthesis system comprising humeral stem, spherical head, and trunnion construct; replaces humeral head in glenohumeral joint. Designed for surgical implantation by orthopedic surgeons to address severe joint pain or disability. Modified from predicate to improve adaptability to humeral head geometry via two adjustable angles. Glenoid components require bone cement for fixation. Device restores joint function and alleviates pain associated with degenerative, traumatic, or necrotic conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Shoulder prosthesis consisting of humeral stem, spherical head, and trunnion. Metal-polymer semi-constrained design. Glenoid components designed for cemented fixation. Modification involves adjustment mechanism for humeral head geometry angles.

Indications for Use

Indicated for patients with severe pain or disability due to degenerative, rheumatoid, or traumatic disease/injury of the glenohumeral joint; non-union humeral head fractures; irreducible 2- or 4-part proximal humeral fractures; or avascular necrosis of the humeral head where arthrodesis or resectional arthroplasty is not acceptable.

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

• Arthrex Shoulder Prosthesis (Univers Shoulder), K010124

Submission Summary (Full Text)

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K07/032

AUG 2 0 2007

Arthrex 8 SPECIAL 510(k): Arthrex Univers II Shoulder Prosthesis

## 4 510(k) Summary of Safety and Effectiveness

| Manufacturer | Arthrex Med. Inst. GmbH<br>Liebigstrasse 13<br>D-85757 Karlsfeld/München<br>Germany |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Distributor/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | Nancy Hoft<br>Regulatory Affairs Associate<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 1113<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex Univers II Shoulder Prosthesis |
| Common Name | Shoulder Prosthesis |
| Product Code -<br>Classification Name | KWS - Prosthesis, Shoulder, semi constrained metal/polymer,<br>cemented<br>HSD - Prosthesis, Shoulder, hemi-humeral, metal, uncemented |
| Predicate Device | Arthrex Shoulder Prosthesis (Univers Shoulder), K010124 |
| Device Description<br>and Intended Use | The Arthrex Univers II Shoulder Prosthesis consists of a stem for<br>attachment to the humerus, a spherical head for replacing the<br>humeral head, and a trunnion construct to connect the stem to the<br>spherical head. The modified device is identical to the cleared<br>predicate (K010124) except for how it addresses two of the three<br>key angles that can be adapted to match the geometry of the<br>humeral head.<br><br>The Arthrex Univers II Shoulder Prosthesis is indicated in<br>replacements(s) when conditions include severe pain or significant<br>disability resulting from degenerative, rheumatoid, traumatic disease,<br>or injury of the glenohumeral joint; non-union humeral head fractures<br>of long duration; irreducible 2- and 4- part proximal humeral<br>fractures; avascular necrosis of the humeral head; or other difficult<br>clinical management problems where arthrodesis or resectional |
| | arthroplasty is not acceptable. |
| | The glenoid components are designed for cemented fixation in the<br>joint and must only be used with an appropriate bone cement. |
| <b>Substantial</b><br><b>Equivalence Summary</b> | The Arthrex Univers II Shoulder Prosthesis is substantially<br>equivalent to the predicate Arthrex Univers Shoulder Prosthesis in<br>which the basic features and intended uses are the same. Any<br>differences between the Arthrex Univers II Shoulder Prosthesis and<br>the predicate Arthrex Univers Shoulder Prosthesis are considered<br>minor and do not raise questions conceming safety and<br>effectiveness. Based on the information submitted, Arthrex, Inc. has<br>determined that the new Arthrex Univers II Shoulder Prosthesis is<br>substantially equivalent to the currently marketed predicate device. |

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Arthrex D SPECIAL 510(k): Arthrex Univers II Shoulder Prosthesis

.

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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 consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 0 2007

Arthrex, Inc. % Ms. Nancy Holt Regulatory Affairs Associate 1370 Creekside Boulevard Naples, FL 34108-1945

Re: K071032

Trade/Device Name: Arthrex Univers II Shoulder Prosthesis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal-polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS, HSD Dated: July 20, 2007 Received: July 23, 2007

Dear Ms. Holt:

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 (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.

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Page 2 - Ms. Nancy Holt

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Barbara Buchup

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

Enclosure

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SPECIAL 510(k): Arthrex Univers II Shoulder Prosthesis

Indications for Use

510(k) Number:

Device Name:

Arthrex Univers II Shoulder Prosthesis

The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

PAGE 1 of 1

Darlene Buenn

Division of General, Restorative, and Neurological Devices

510(k) Number K07/032

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