BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS

K043100 · Biomet, Inc. · MBF · Feb 17, 2005 · Orthopedic

Device Facts

• Record ID: K043100
• Device Name: BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
• Applicant: Biomet, Inc.
• Product Code: MBF · Orthopedic
• Decision Date: Feb 17, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 1 . 2. Rheumatoid arthritis. Revision where other devices or treatments have failed, 3. 4. Correction of functional deformity, Fractures of the proximal humerus, where other methods of treatment are deemed inadequate, 5. Difficult clinical management problems, including cuff arthropathy, where other methods of 6. treatment may not be suitable or may be inadequate. Humeral components with a Macrobond® surface coating are indicated for either cemented 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). Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications (Metal backed glenoid components offer optional screw fixation). Humeral components with a non-coated (Interlok ) surface are indicated for cemented application only. Polyethylene glenoid components not attached to a metal back are indicated for cemented application only. The Complehensive Humeral Fracture Stem is intended for use with the Bio-Modular® humeral heads and glenoid components Fhe Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive Humeral Fracture Stem and the glenoid components of the Bio-Modular® Shoulder System

Device Story

Bio-Modular Shoulder System is a modular shoulder prosthesis for total or hemi-shoulder arthroplasty. System comprises humeral stems, humeral heads, and glenoid components. Subject device adds Hydroxyapatite (HA) coating to metal-backed glenoid components to facilitate biological fixation. Intended for uncemented use; optional screw fixation provided. Used by orthopedic surgeons in clinical settings to replace diseased or damaged shoulder joints. HA coating promotes bone ingrowth, potentially improving implant stability and long-term fixation compared to non-coated porous surfaces. Device components are assembled intraoperatively based on patient anatomy.

Clinical Evidence

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

Technological Characteristics

Shoulder prosthesis components made of titanium alloy. Features porous coating with an additional Hydroxyapatite (HA) coating layer. Designed for uncemented biological fixation with optional screw fixation. Modular design.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal humerus fractures, or difficult clinical management problems (e.g., cuff arthropathy) requiring total or hemi-shoulder arthroplasty.

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

• Bio-Modular® Shoulder System (K030710)

Submission Summary (Full Text)

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K043100

FEB 1 7 2005

BIOMET

## 510(k) Summary

| Applicant/Sponsor: | Biomet Manufacturing Corp.<br>56 East Bell Drive<br>Warsaw, IN 46582<br>FDA Registration #: 1825034 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Baker<br>Biomet Manufacturing Corp.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587<br>Phone: (574) 267 - 6639<br>FAX: (574) 372 - 1683 |
| Proprietary Name: | Bio-Modular® Shoulder System - Hydroxyapatite Coated Glenoid Components |
| Common Name: | Shoulder prosthesis |
| Classification Name: | The Bio-Modular® Shoulder System - Hydroxyapatite Coated Glenoid Components are included in the following classification:<br>1. Shoulder Joint, Metal/Polymer/Metal, Non-Constrained or Semi-constrained, Porous Coated, Uncemented Prosthesis 21 CFR § 888.3670 |

The Bio-Modular® Shoulder System has been cleared for:
1. Shoulder Joint, Metal/Polymer/Metal, Non-Constrained or Semi-constrained, Porous Coated, Uncemented Prosthesis 21 CFR § 888.3670
2. Shoulder Joint, Metal/Polymer, Non-constrained, Cemented Prosthesis 21 CFR §888.3650
3. Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Cemented 21 CFR § 888.3660
4. Shoulder Joint, Humeral, "Hemi-Shoulder," Metallic, Uncemented Prosthesis 21 CFR § 888.3690

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Bio-Modular® Shoulder System (K030710) – Biomet Inc.

Device Description: The Bio-Modular® Shoulder System is a set of components intended for total or hemi shoulder arthroplasty. It consists of humeral stems, humeral heads, and glenoid components. The only change to this system proposed by this submission is the addition of Hydroxyapatite (HA) coating to the glenoid components that utilize metal backs and are intended for biological fixation with optional screw fixation. The HA coated glenoid components are intended only for total shoulder arthroplasty.

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| MAILING ADDRESS<br>P.O. Box 587<br>Warsaw, IN 46581-0587 | SHIPPING ADDRESS<br>56 E. Bell Drive<br>Warsaw, IN 46582 |
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574.267.6639

FAX
574.267.8137

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E-MAIL [e-mail]

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K043100

p. 2/2

Intended Use:

Indications For Use:

- 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis, 2.
- 3. Revision where other devices or treatments have failed,
- Correction of functional deformity, ধ
- ડ. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
- 6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
- A Humeral components with a Macrobond® surface coating are indicated for either cemented or uncemented press-fit applications.
- A 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).
- A Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications (Metal backed glenoid components offer optional screw fixation).
- Humeral components with a non-coated (Interlok") surface are indicated for cemented application A only.
- Polyethylene glenoid components not attached to a metal back are indicated for cemented application A only.

The Comprehensive Humeral Fracture Stem is intended for use with the Bio-Modular® humeral heads and glenoid components.

The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive Humeral Fracture Stem and the glenoid components of the Bio-Modular® Shoulder System.

## Summary of Technologies:

The Bio-Modular Shoulder System with the Hydroxyapatite coated glenoid components has the same intended use, the same mechanical design, the same functional characteristics, and is made of the same titanium alloy as the predicate device.

- Non-Clinical Testing: The modified devices were found to be substantially equivalent to the predicate devices.
- Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.

All trademarks are property of Biomet. Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

FEB 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K043100

Trade Name: Bio-Modular® Shoulder System-Hydroxyapatite Coated Glenoid Components Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBF Dated: January 14, 2005 Received: January 18, 2005

Dear Mr. Baker:

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 svstems (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. Gary Barker

This letter will allow you to begin marketing your device as described in your Section 510(k) rms leket natification. The FDA finding of substantial equivalence of your device to a legally prematice hotified.om "Thesults 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 n you accire 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 other general 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 A. Milkersen

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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## Indications For Use

510(k) Number (JF K NOWN) -

Device Name: Bio-Modular* Shoulder System – Hydroxyapatite Coated Glenoid Components

Indications For Use:

- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 1 .
- 2. Rheumatoid arthritis.
- Revision where other devices or treatments have failed, 3.
- 4. Correction of functional deformity,
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate, 5.
- Difficult clinical management problems, including cuff arthropathy, where other methods of 6. treatment may not be suitable or may be inadequate.
- Humeral components with a Macrobond® surface coating are indicated for either cemented press-ﺮ ﺍ fit applications.
- Humeral glenoid components with a porous coated surface coating are indicated for either cemented or ﺮ uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).
- Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for r uncemented biological fixation applications (Metal backed glenoid components offer optional screw fixation).
- Humeral components with a non-coated (Interlok ) surface are indicated for cemented application only. ﻨﺮ
- Polyethylene glenoid components not attached to a metal back are indicated for cemented application only. ﺮ

The Complehensive Humeral Fracture Stem is intended for use with the Bio-Modular® humeral heads and glenoid components

Fhe Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive Humeral Fracture Stem and the glenoid components of the Bio-Modular® Shoulder System

Prescription Use (Per 21 CFR 801 Subpart D) Over-The-Counter Use _ (Per 21 CFR 807 Subpart C)

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

and/or

Concurrence of CDRH. Office of Device Evaluation (ODE)

*Mach N Mill*

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

K073100