DVO EXTENDED ARTICULATION HUMERAL HEADS

K073331 · Dvo Extremity Solutions, LLC · HSD · Feb 19, 2008 · Orthopedic

Device Facts

• Record ID: K073331
• Device Name: DVO EXTENDED ARTICULATION HUMERAL HEADS
• Applicant: Dvo Extremity Solutions, LLC
• Product Code: HSD · Orthopedic
• Decision Date: Feb 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DVO " Total Extended Articulation Humeral Heads are intended for use in hemishoulder arthroplasty.

Device Story

Extended Articulation Humeral Heads are modular shoulder prosthesis components designed for hemi-arthroplasty. Constructed from cobalt chrome alloy, these highly polished, semispherical heads mate with previously cleared humeral stems via a locking taper. Available in sizes 44-56mm (4mm increments) and heights of 18-21mm. Intended for surgical implantation by orthopedic surgeons in a hospital setting. The device replaces the humeral head to restore joint function in patients with specific degenerative or traumatic conditions. It does not articulate with glenoids. Sterile, single-use device.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use similarities to predicate devices.

Technological Characteristics

Material: Cobalt chrome alloy. Design: Semispherical, highly polished humeral head. Dimensions: 44-56mm diameter, 18-21mm height. Interface: Locking taper for humeral stem attachment. Sterilization: Gamma irradiation. Single-use.

Indications for Use

Indicated for patients requiring hemi-shoulder replacement due to ununited humeral head fractures, avascular necrosis of the humeral head, or rotator cuff tear arthropathy.

Regulatory Classification

Identification

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.

Predicate Devices

• DePuy Global Advantage Extended Humeral Heads (K000575)
• DVO Total and Hemi Shoulder System (K060988)

Submission Summary (Full Text)

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K073331 (pg. 1 of 2)

Image /page/0/Picture/1 description: The image shows the logo for DVO Extremity Solutions. The logo consists of the letters "DVO" in large, bold, white font against a black background. Below the letters, the words "Extremity Solutions" are written in a smaller, bold, black font. The address "720 E. Winona Ave., Warsaw, IN 46580" is printed below the company name.

FEB 19 2000

# 510(k) Summary of Safety and Effectiveness

| SUMMARY PREPARED: | November 26, 2007 |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------|
| 510(k) SPONSOR and<br>APPLICANT: | DVOTM Extremity Solutions, LLC<br>720 E. Winona Ave., Warsaw IN 46580 |
| CONTACT PERSON: | Jeff Ondrla,<br>Vice President, Product Development<br>[phone]<br>[e-mail] |
| TRADE NAME: | Extended Articulation Humeral Heads |
| COMMON NAMES: | Shoulder prosthesis, humeral head |
| CLASSIFICATION,<br>CLASS and<br>PRODUCT CODE: | 21 CFR 888.3690, Class II, 87 HSD |
| PREDICATE DEVICES: | DePuy Global Advantage Extended Humeral Heads,<br>K000575<br>DVO Total and Hemi Shoulder System, K060988 |

#### DEVICE DESCRIPTION:

The Extended Articulation Humeral Heads are an addition to the previously cleared modular DVO Total and Hemi Shoulder System. The cobalt chrome alloy, semispherical heads mate with the previously cleared humeral stems through a locking taper. The heads are highly polished. They do not articulate with the previously cleared glenoids as they are intended to be used in hemi-arthroplasty applications only.

The heads are available in four sizes, 44 to 56mm, in 4mm increments, and in heights of 18 and 21 mm.

(Continued on next page)

Page 1 of 2

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K073331 (pg. 2 of 2)

Image /page/1/Picture/1 description: The image shows the logo for DVO Extremity Solutions. The logo has the letters DVO in a large, bold font at the top. Below that is the text "Extremity Solutions" in a smaller, bold font. The address "720 E. Winona Ave., Warsaw, IN 46580" is printed below the company name.

## 510(k) Summary of Safety and Effectiveness

## INTENDED USE:

The DVO " Total Extended Articulation Humeral Heads are intended for use in hemishoulder arthroplasty.

## INDICATIONS FOR USE:

The DVO™ Total Extended Articulation Humeral Heads, for use in hemi-shoulder replacement, are indicated for:

- 1. Ununited humeral head fractures;
- 2. Avascular necrosis of the humeral head.
- 3. Rotator cuff tear arthropathy.

Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are also indicated for press-fit uncemented use or for use with bone cement. These are sterile, single use devices.

COMPARISON TO PREDICATES:

The DVO Extended Articulation Humeral Heads are similar to the listed predicate devices in intended use for hemi shoulder replacement, indications for use, design, materials of construction (cobalt chrome alloy), methods of sterilization (gamma irradiation), packaging, and manufacturing methods.

Page 2 of 2

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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 consists of a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

FEB 19 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DVOTM Extremity Solutions, LLC % Mr. Jeff Ondrla Vice President, Product Development 720 East Winona Avenue Warsaw, Indiana 46580

Re: K073331

Trade/Device Name: DVOTM Extended Articulation Humeral Heads Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: November 26, 2007 Received: December 11, 2007

Dear Mr. Ondrla:

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

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Page 2 - Mr. Jeff Ondrla

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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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.

Mark M. Mulhern

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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#### Indications for Use

510(k) Number (if known): K073331

Device Name: DVOTM Extended Articulation Humeral Heads

Indications for Use: The DVO™ Extended Articulation Humeral Heads for use in hemi-shoulder replacement are indicated for:

- 1. Ununited humeral head fractures;
- 2. Avascular necrosis of the humeral head.
- 3. Rotator cuff tear arthropathy.

Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Hurneral stems are also indicated for press-fit uncemented use or for use with bone cement. These are sterile, single use devices.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Mark A. Milkman

(Division Sign-Of (Division of General, Restorative, Division of Neurological Devices

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510(k) Number