ARTHREX UNIVERS II SHOULDER PEGGED GLENOID

K083435 · Arthrex, Inc. · KWS · Jun 26, 2009 · Orthopedic

Device Facts

• Record ID: K083435
• Device Name: ARTHREX UNIVERS II SHOULDER PEGGED GLENOID
• Applicant: Arthrex, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Jun 26, 2009
• 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

The Arthrex Univers II Shoulder Pegged Glenoid is a shoulder prosthesis component; manufactured from UHMWPE in three sizes. The device features a concave lateral articular surface for articulation with Univers or Univers II humeral stems; a convex medial surface with three pegs for cement interdigitation. Used in orthopedic surgery; implanted by a surgeon to replace the glenohumeral joint. The device requires bone cement for fixation. It provides a prosthetic surface to restore joint function and alleviate pain in patients with severe joint disease or fractures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

Material: UHMWPE. Design: Three-peg glenoid component for cemented fixation. Articulation: Concave lateral surface for humeral head interface. Fixation: Cemented. Dimensions: Three sizes available.

Indications for Use

Indicated for patients with severe pain or disability due to degenerative, rheumatoid, or traumatic glenohumeral joint disease/injury; 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 Univers II Shoulder Prosthesis (K071032)
• Arthrex Univers Shoulder Prosthesis (K010124)

Submission Summary (Full Text)

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K083435 (pg. 1 of 2)

## JUN 26 2009

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Arthrex: SPECIAL: 510(li); Arthrex Univers II Shoulder Peagged Glenoid

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# 510(Jk) Summary of Safety and Eilectiv

| Manufacturer/Distributor/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact | Sally Foust<br>Regulatory Affairs Project Manager<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 1251<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex Univers II Shoulder Pegged Glenoid |
| Common Name | Shoulder Prosthesis |
| Product Code -Classification Name | KWS - Prosthesis, Shoulder, semi constrained<br>metal/polymer, cemented<br>HSD - Prosthesis, Shoulder, hemi-humeral, metal,<br>uncemented |
| Predicate Devices | Arthrex Univers II Shoulder Prosthesis, K071032<br>Arthrex Univers Shoulder Prosthesis, K010124 |
| Device Description and Intended<br>Use | The Arthrex Univers II Shoulder Pegged Glenoid is<br>manufactured in three sizes from UHMWPE. The<br>glenoid articular (lateral) surface is concave and<br>articulates with the humeral head of the Univers or<br>Univers II humeral stems. The fixation (medial) surface is<br>convex and is designed with three pegs for cement<br>interdigitation fixation.<br>The Arthrex Univers II Shoulder Prosthesis is indicated in<br>replacements(s) when conditions include severe pain or<br>significant disability resulting from degenerative,<br>rheumatoid, traumatic disease, or injury of the<br>glenohumeral joint; non-union humeral head fractures of<br>long duration; irreducible 2- and 4- part proximal humeral<br>fractures; avascular necrosis of the humeral head; or<br>other difficult clinical management problems where<br>arthrodesis or resectional arthroplasty is not acceptable. |
| | The glenoid components are designed for cemented<br>fixation in the joint and must only be used with an<br>appropriate.bone cement. |
| Substantial Equivalence<br>Summary | The Arthrex Univers II Shoulder Pegged Glenoid is<br>substantially equivalent to the predicate Arthrex Univers<br>Shoulder Prosthesis in which the basic features and<br>intended uses are the same. Any differences between<br>the Arthrex Univers II Shoulder Pegged Glenoid and the<br>predicate Arthrex Univers Shoulder Prosthesis or<br>Univers II Shoulder Prosthesis are considered minor and<br>do not raise questions conceming safety and<br>effectiveness. Based on the information submitted,<br>Arthrex, Inc. has determined that the new Arthrex<br>Univers II Shoulder Pegged Glenoid is substantially<br>equivalent to the currently marketed predicate device. |

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K083435 (pg. 2 of 2)

ArthreX SPECIAL 510gly): Arthrex Univers II Shoulder Peagged Glerioid

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Public Health Service

#### JUN 26 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrex, Incorporated % Ms. Sally Foust, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K083435

Trade/Device Name: Arthrex Univers II Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal-polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS, HSD Dated: May 29, 2009 Received: June 3, 2009

Dear Ms. Foust:

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 (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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#### Page 2 - Ms. Sally Foust, RAC

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,

Harbay Mueller

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

Enclosure

K083435-Arthrex, Incorporated

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Arthrex SPECIAL 510(k): Airthrex Univers 11 Shoulder Regged Glenolds

### Indications for Use

510(k) Number:

Device Name:

#### Arthrex Univers II Shoulder Prosthesis

K083435

The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, theumatoid, 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 Byaluation (ODE)

PAGE 1 of 1

Charlae Burns

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083435