VERSA-DIAL HUMERAL HEAD PROSTHESIS

K060716 · Biomet Manufacturing Corp · MBF · Jun 12, 2006 · Orthopedic

Device Facts

• Record ID: K060716
• Device Name: VERSA-DIAL HUMERAL HEAD PROSTHESIS
• Applicant: Biomet Manufacturing Corp
• Product Code: MBF · Orthopedic
• Decision Date: Jun 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Versa-Dial™ Humeral Head Prosthesis is intended for: 1) Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis. Rheumatoid arthritis. 2) Revision where other devices or treatments have failed. 3) 4) Correction of functional deformity. 5) Fractures of the proximal humerus where other methods of treatment are deemed inadequate. Difficult clinical management problems, including cuff tear arthropathy, where other methods of treatment may not be suitable or may be inadequate. Humeral components with a MacroBond® surface coating are indicated for either cemented or uncemented press-fit applications. Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation.) Polyethylene glenoid components not attached to a metal back are indicated for cemented application only. The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive® Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular® Shoulder Stems, and the glenoid components of the Bio-Modular® Shoulder System. The device is a single use implant.

Device Story

Modular humeral head prosthesis system; provides variable offset (0.5mm to 4.5mm) to restore joint biomechanics. Consists of modular head and taper adaptor; adaptor impacted into head to set desired offset. Used in shoulder arthroplasty; implanted by orthopedic surgeons in clinical/hospital settings. Compatible with Comprehensive® and Bio-Modular® shoulder stems. Single-use implant; provides structural replacement for damaged humeral head; facilitates joint function restoration. Redesigned taper adaptor utilizes Ti-6Al-4V alloy.

Clinical Evidence

No clinical data provided. Substantial equivalence based on non-clinical laboratory testing.

Technological Characteristics

Modular humeral head prosthesis; materials include Ti-6Al-4V for taper adaptor. Features MacroBond® surface coating for press-fit or porous coating for biological fixation. Variable offset range 0.5mm to 4.5mm. Single-use implant.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal humerus fractures, or cuff tear arthropathy requiring revision or where other treatments are inadequate. For use with specific Biomet shoulder stems and glenoid components.

Regulatory Classification

Identification

A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”

Predicate Devices

• Versa-Dial™ Humeral Head Prosthesis (K040610)
• Blo-Modular® Shoulder System (K030710)
• Absolute® Bl-Polar Shoulder System (K002998)

Submission Summary (Full Text)

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JUN 1 2 2006

# 510(k) Summarv

| Preparation Date: | June 8, 2006 |
|--------------------|-------------------------------------|
| Applicant/Sponsor: | Blomet Manufacturing Corp. |
| Contact Person: | Susan Alexander |
| Proprietary Name: | Versa-Dial™ Humeral Head Prosthesis |
| Common Name: | Shoulder Prosthesis |

## Classification Name:

- Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR §888.3650) .
- Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 5888.3660) .
- Shoulder joint metal/polymer/metal/non-constrained or semi-constrained porous-coated . uncemented prosthesis (21 CFR 6888,3670)
- . Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (21 CFR 888.3690)

### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

- Versa-Dial™ Humeral Head Prosthesis; Blomet Manufacturing Corp. (K040610) .
- . Blo-Modular® Shoulder System; Blomet Orthopedics, Inc. (K030710)
- Absolute® Bl-Polar Shoulder System; Blomet Manufacturing Corp. (K002998) ●

Device Description: The Versa-Dial™ Humeral Head Prosthesis consists of a series of varioussized modular humeral heads with variable offset between 0.5mm and 4.5 mm. Each modular head consists of a head and a taper adaptor. The taper adaptor is impacted into the head in a certain position to achieve the desired amount of offset. The system can be used with Blomet's Comprehensive® Shoulder System or Biomet's BioModular® Shoulder System depending upon which taper is used (i.e., in order to use with the Comprehensive® shoulder stem, the Comprehensive® Taper Adaptor must be used).

Intended Use: The Versa-Dial™ Humeral Head Prosthesis is intended for:

- 1) Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis. 2)
- Revision where other devices or treatments have falled. 3)
- 4) Correction of functional deformity.
- 5) Fractures of the proximal humerus where other methods of treatment are deemed Inadequate.
- Difficuit dinical management problems, Including cuff tear arthropathy, where other ର) methods of treatment may not be sultable or may be Inadequate.

Humeral components with a MacroBond® surface coating are indicated for either cemented or uncemented press-fit applications.

| 5-1 | | |
|---------------------------------------|--------------------------------------|-------------------|
| MAILING ADDRESS | SHIPPING ADDRESS | |
| P.O. Box 587<br>Warsaw, IN 46581 0587 | 56 E. Bell Drive<br>Warsaw, IN 46582 | |
| OFFICE | FAX | E-MAIL |
| 574.267.6639 | 574.267.8187 | [e-mail] |

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### Page 2 of 2 510(k) Summary; Versa-Dlal™ Humeral Head Prosthesis Blomet Manufacturing Corp.

Hymeral/glenoid components with a porous coated surface coating are Indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation.)

Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive® Shoulder Stems (Fracture, Primary and Revision), the Blo-Modular® Shoulder Stems, and the glenoid components of the Bio-Modular® Shoulder System.

The device is a single use implant.

Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the Versa-Dial™ Humeral Head Prosthesis are similar or identical to the predicate devices. The device has been redesigned since it was deared in K040610. The redesigned Versa-Dial™ taper adaptor is comprised of TT-6AI-4V; the predicate Versa-Dial™ taper adaptor is made of Co-Cr-Mo. The Indicla on the underside of the new device have changed from numbers to letters.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results Indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

Unless otherwise noted, all trademarks are property of Blomet.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract eagle design with three stylized lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2006

Biomet Manufacturing Corp. % Ms. Susan Alexander Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K060716 Trade/Device Name: Versa-Dial™ Humeral Head Prosthesis Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, KWT, KWS, HSD Dated: March 16, 2006 Received: March 17, 2006

Dear Ms. Alexander:

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. Susan Alexander

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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Herbert Semmler

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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K060716

# Indications for Use

510(k) Number (if known):_

Device Name: Versa-Dial™ Humeral Head Prosthesis

Indications For Use:

The Versa-Dial™ Humeral Head Prosthesis Is intended for:

- 1) Non-Inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
- 2) Rheumatoid arthritis.
- 3) Revision where other devices or treatments have failed.
- 4) Correction of functional deformity.
- 4) Corrector of the proximal humerus where other methods of treatment are deemed Inadequate.
- indequate: methods of treatment may not be suitable or may be inadequate.

Humeral components with a MacroBond® surface coating are indicated for either cemented or uncemented press-fit applications.

Humeral/glenoid components with a porous coated surface coating are Indicated for either cemented or uncemented blological fixation applications. (Metal backed glenoid components offer optional screw fixation.)

Polyethylene glenold components not attached to a metal back are indicated for cemented application only.

The Versa-Dial™ Humeral Head Prosthesis is Intended for use only with the Comprehensive® Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular® Shoulder Stems, and the glenold components of the Blo-Modular® Shoulder System.

The device is a single-use implant.

X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Hubert Lemmer

Division Sign-Of Division of General, Restorage of 1 and Neurological Devices

1060716 510(k) Number_