DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM

K043505 · Biomet, Inc. · KWT · Feb 9, 2005 · Orthopedic

Device Facts

• Record ID: K043505
• Device Name: DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
• Applicant: Biomet, Inc.
• Product Code: KWT · Orthopedic
• Decision Date: Feb 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for use for the Discovery™ - Mosaic™ Total Humerus System include: 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 5. Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods 6. Oncology applications The Discovery™ - Mosaic™ Total Humerus System is intended for cemented use only.

Device Story

Total humerus prosthesis system; modular design combining Discovery Elbow components, 3-Piece Proximal Humeral Replacement System components, and an intercalary segment. Used for total humeral replacement in orthopedic surgery. Implanted by surgeons to restore joint function in patients with severe fractures, degenerative disease, or oncology-related bone loss. System utilizes modular heads and glenoid components; intended for cemented fixation only. Provides structural replacement of the humerus to facilitate limb salvage and functional recovery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Modular shoulder/elbow prosthesis system. Materials are identical to predicate devices (metal/polymer). Intended for cemented use only. Non-constrained design.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, acute/chronic fractures involving humeral epicondyle or humeral head unmanageable by other methods, oncology applications, or revision cases.

Regulatory Classification

Identification

A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation 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, 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1378-97 “Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System (K033280)
• 3 Piece Proximal Humeral Replacement System (K020045)

Submission Summary (Full Text)

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K043505

FEB - 9 2005

#### 510(k) Summary

Applicant/Sponsor:

Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Contact Person:

Gary Baker Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587 Phone: [phone] FAX: [phone]

Proprietary Name: Discovery™ - Mosaic™ Total Humerus System

Shoulder Prosthesis Common Name:

Classification Name: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer, Cemented (21 CFR 888.3650)

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

Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System: K033280 -Biomet Inc. 3 Piece Proximal Humeral Replacement System: K020045 - Biomet Inc.

#### Device Description:

The Discovery™ - Mosaic™ Total Humerus System includes the components of the Discovery Elbow, the components of the 3 Piece Proximal Humeral Replacement System, and an intercalary segment designed to connect them. The Discovery™ - Mosaic™ Total Humerus System uses the same modular heads and glenoid components that were cleared for use in the predicate 3 Piece Proximal Humeral Replacement System.

> MAHING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

> > .

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

()FFICE 574.267.6639

ト・ヘ× 574.267.8137

E-MAIL [e-mail]

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K043565 Lot 2

## Intended Use:

The indications for use for the Discovery™ – Mosaic™ Total Humerus System include:

- leations for use for the degencrative joint disease including osteoarthritis and avascular necrosis
- 2. Rheumatoid arthritis
- Revision where other devices or treatments have failed 3.
- Correction of functional deformity 4.
- Correction of famononal deformic fractures with humeral epicondyle (elbow) ર્ડ . involvement or humeral head (shoulder), which are unmanageable using other treatment methods
- 6. Oncology applications

The Discovery™ - Mosaic™ Total Humerus System is intended for cemented use only.

# Summary of Technologies:

al your recimiologies:
The Discovery™ - Mosaic™ Total Humerus System components have the same intended The Discovery - - Hosare - and are manufactured from the same materials as the predicate devices.

## Non-Clinical Testing:

illical Testing.
The performance data indicated that the Discovery™ - Mosaic™ Total Humerus System is I ric performally equivalent to the predicate devices for the uses indicated.

## Clinical Testing:

It Testing was not required for these components to support 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 black and white emblem for the U.S. Department of Health & Human Services. The emblem is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of three overlapping lines that resemble a person.

FEB - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K043505

Trade/Device Name: Discovery™ - Mosaic ™ Total Humerus System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: KWT Dated: December 17, 2004 Received: December 20, 2004

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 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. Baker

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,
Mark N. Millanvor

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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## Page 1 of 1

## Statement of Indications For Use

510(k) Number (IF KNOWN): Kby 3500

Device Name: Discovery™ - Mosaic™ Total Humerus System

## Indications for Use:

The indications for use for the Discovery™ - Mosaic™ Total Humerus System include:

- 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
- Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement or న్న humeral head (shoulder), which are unmanageable using other treatment methods
- 6. Oncology applications

The Discovery™ - Mosaic™ Total Humerus System is intended for cemented use only.

Prescription Use ズ (Per 21 CFR 801 Subpart D) OR

Over-the-Counter Use (Per 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)

Mark M. Millinson

510(k) Number