ARTHREX UNIVERS FRACTURE PROSTHESIS

K020345 · Arthrex, Inc. · KWS · Sep 6, 2002 · Orthopedic

Device Facts

• Record ID: K020345
• Device Name: ARTHREX UNIVERS FRACTURE PROSTHESIS
• Applicant: Arthrex, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Sep 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Shoulder Humeral Fracture Prosthesis is indicated for severe pain or significant disability resulting from degenerative, rheumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures, comminuted fracture, humeral head fracture, displaced 3-or4-fraqment proximal head fractures, avascular necrosis of the humeral head, and fractures of the anatomical neck. The Arthrex Shoulder Humeral Fracture Prosthesis is designed for cemented or non-cemented use. This device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.

Device Story

Shoulder prosthesis for hemi or total shoulder arthroplasty; treats severe pain/disability from degenerative, rheumatoid, or traumatic joint conditions. Device components: titanium (Ti6Al4V) stem body with height adjustment mechanism; titanium head support; Cr-Co alloy prosthesis head. Used in surgical settings by orthopedic surgeons. Provides structural replacement for humeral head; may be used with Arthrex Univers Glenoid component for total shoulder repair. Cemented or non-cemented fixation options. Benefits patient by restoring joint function and reducing pain associated with complex fractures or necrosis.

Clinical Evidence

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

Technological Characteristics

Materials: Titanium (Ti6Al4V) stem and head support; Cr-Co alloy head. Features: Stem body with height adjustment mechanism. Fixation: Cemented or non-cemented. Application: Hemi or total shoulder repair (with optional cemented glenoid component).

Indications for Use

Indicated for patients with severe pain or disability due to degenerative, rheumatoid, or traumatic glenohumeral joint disease/injury. Includes conditions such as impression fractures, comminuted fractures, humeral head fractures, displaced 3- or 4-fragment proximal head fractures, avascular necrosis, and anatomical neck fractures.

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.”

Submission Summary (Full Text)

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0 20345

6 2002 SEP

510(k) Summary

page 1 of 1

Arthrex, Inc. Company: 2885 S. Horseshoe Drive, Naples, FL 34104 Address: [phone] Phone: Phone: [phone] Fax:

| Contact: | Vernon C. Brown<br>Manager of Regulatory Affairs |
|----------|--------------------------------------------------|
|----------|--------------------------------------------------|

| Trade Name: | Arthrex Shoulder Humeral Fracture Prosthesis |
|-----------------|----------------------------------------------------------------|
| Common Name: | Shoulder Prosthesis |
| Classification: | Prosthesis, Shoulder, semi-constrained, metal/polymer cemented |
| | Prosthesis, shoulder, Hemi-, Humeral, metallic uncemented |

### Description:

The device consists of: a stem body with a height adjustment mechanism in the neck section, composed of titanium (Ti6Al4V); a metal head support also of titanium; the prosthesis head composed of Cr-CO alloy. This device may be used for total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.

### Intended Use:

The Arthrex Shoulder Humeral Fracture Prosthesis is indicated for severe pain or significant disability resulting from degenerative, rheumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures, comminuted fracture, humeral head fracture, displaced 3-or4-fraqment proximal head fractures, avascular necrosis of the humeral head, and fractures of the anatomical neck.

## Substantial Equivalence:

By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device.

The differences between the Arthrex Shoulder Prosthesis and the predicate devices cited do not raise any different questions regarding safety and effectiveness. Furthermore, the rnaterials are well characterized, and have been used in the predicate devices which have nearly identical indications. The device, as designed, is as safe and effective as the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 design of three human profiles facing to the right, stacked on top of each other.

#### 6 2002 SEP

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Vernon C. Brown Manager of Regulatory Affairs Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104

Re: K020345

Trade/Device Name: Arthrex Shoulder Humeral Fracture Prosthesis Regulation Number: 21 CFR 888.3660 and 888.3690 Regulation Name: Shoulder joint, metal/polymer, semi-constrained cemented prosthesis; and shoulder joint, humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: KWS and HSD Dated: May 31, 2002 Received: June 12, 2002

Dear Mr. Brown:

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 - Mr. Vernon C. Brown

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Atyt Plurde
Celia M. Witten, Ph.D., M.D.

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

Enclosure

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# Appendix 3

# Indications for Use Form

Page I of I

| 510(k) Number (if known): | K020345 |
|---------------------------|----------------------------------------------|
| Device Name: | Arthrex Shoulder Humeral Fracture Prosthesis |

Indications For Use:

The Arthrex Shoulder Humeral Fracture Prosthesis is indicated for severe pain or The Arthrex Onounce Transfar Haseberative, rheumatoid, or traumatic disease or Significant disability Teauking Trom 'digences traumatic or pathological conditions of the injury of the glonomeneral joint, including impression fractures, Shoulder resulting in humeral head fracture, displaced 3-or4-fragment proximal head Contininuted Tracture, The humeral head, and fractures of the anatomical neck.

The Arthrex Shoulder Humeral Fracture Prosthesis is designed for cemented or non-The Armex Onodidor Highbrun be used for hemi or total shoulder repair, utilizing the echnented ase. " This donoo may at which is to be cemented in place.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

OR

(Optional Format 1-2-96)

24

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________