ARTHREX UNIVERS APEX

K131633 · Arthrex, Inc. · KWS · Sep 27, 2013 · Orthopedic

Device Facts

• Record ID: K131633
• Device Name: ARTHREX UNIVERS APEX
• Applicant: Arthrex, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Sep 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Univers Apex 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

Humeral stem component of shoulder prosthesis system; consists of stem, trunion, inclination block, pins, and screws. All components manufactured from titanium. Used in orthopedic surgery for glenohumeral joint replacement. Device provides structural support for joint reconstruction. Mechanical fatigue strength validated to be comparable to predicate devices. Intended for use by surgeons in clinical settings.

Clinical Evidence

Bench testing only. Mechanical fatigue strength testing demonstrated performance comparable to predicate devices.

Technological Characteristics

Humeral stem system; materials: titanium; components: stem, trunion, inclination block, pins, screws; fixation: glenoid components require bone cement; design: semi-constrained shoulder prosthesis.

Indications for Use

Indicated for patients requiring shoulder joint replacement due to severe pain or disability from degenerative, rheumatoid, or traumatic disease/injury; non-union humeral head fractures; irreducible 2- or 4-part proximal humeral fractures; 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

• Arthrex Univers II Shoulder Prosthesis (K071032 / K103466)
• Comprehensive Primary Shoulder Stems (K060692)

Submission Summary (Full Text)

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K131633 (1/2)

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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 2 1 ።

| Date Summary Prepared | August 17, 2013 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | Courtney Smith<br>Regulatory Affairs Manager<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 1720<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex Univers Apex |
| Common Name | Shoulder Prosthesis |
| Product Code -Classification Name | KWS |
| CFR | 888.3660: Prosthesis, Shoulder, Semi-Constrained<br>Metal/Polymer, Cemented<br>HSD<br>888.3690: Prosthesis, Shoulder, Hemi-Humeral, Metal,<br>Uncemented |
| Predicate Device | K071032 / K103466: Arthrex Univers II Shoulder<br>Prosthesis<br>K060692 : Comprehensive Primary Shoulder Stems |
| Purpose of Submission | This Traditional 510(k) premarket notification is<br>submitted to obtain clearance for the Arthrex Univers<br>Apex. |
| Device Description | The Univers Apex is the humeral stem component of a<br>shoulder prosthesis system. It consists of a stem, a<br>trunion, an inclination block and pins and screws. All of<br>the components are comprised of titanium. The Short<br>Stem is identical to the existing Univers II Stem, except |
| | for the overall length. |
| Intended Use | The Univers Apex is Indicated in replacements(s) when<br>conditions include severe pain or significant disability<br>resulting from degenerative, rheumatoid, traumatic<br>disease, or injury of the glenohumeral joint; non-union<br>humeral head fractures of long duration; irreducible 2-<br>and 4- part proximal humeral fractures; avascular<br>necrosis of the humeral head; or, other difficult clinical<br>management problems where arthrodesis or resectional<br>arthroplasty is not acceptable.<br><br>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 Summary | The Arthrex Univers Apex is substantially equivalent to<br>the predicate devices, in which the basic design features<br>and intended uses are the same. Any differences<br>between the Arthrex Univers Apex and the predicates are<br>considered minor and do not raise questions concerning<br>safety and effectiveness. |
| | The proposed devices are comprised of titanium. This<br>material is substantially equivalent to the materials found<br>in the predicate devices. |
| | The submitted mechanical testing data demonstrates<br>that the fatigue strength of the proposed devices are<br>comparable to that of the predicate device for the<br>desired indications. |
| | Based on the indication for use, technological<br>characteristics, and the summary of data submitted,<br>Arthrex, Inc. has determined that the Univers Apex is<br>substantially equivalent to currently marketed predicate<br>devices. |

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three wavy lines representing the branches of the department.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 27, 2013

Arthrex, Incorporated Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108

Re: K131633

Trade/Device Name: Arthrex Univers Apex Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: August 6, 2013 Received: August 7, 2013

Dear Ms. Smith:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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## Page 2 - Ms. Couriney Smith

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/dcfault.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N Melkerson -S

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

Enclosure

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## Indications for Use

510(k) Number (if known):

Arthrex Univers Apex Device Name:

Indications For Use: K131633

The Arthrex Univers Apex 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.

Prescription Use _ V _ AND/OR Over-The-Counter Use __

(Per 21 CFR 801 Subpart D)

(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

Casey L. Hanley, Ph.D.

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Division of Orthopedic Devices