M2A/C2A ACETABULAR SYSTEM

K042841 · Biomet, Inc. · JDL · Dec 21, 2004 · Orthopedic

Device Facts

• Record ID: K042841
• Device Name: M2A/C2A ACETABULAR SYSTEM
• Applicant: Biomet, Inc.
• Product Code: JDL · Orthopedic
• Decision Date: Dec 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3320
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The M²a™/C²a™ Acetabular System is intended for cemented or noncemented use in cases of: 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Revision procedures where other treatment or devices have been unsuccessful 5) Treatment of non-union, femoral neck fracture, trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

Device Story

M²a™/C²a™ Acetabular System is a metallic hip joint prosthesis; consists of hemispherical titanium outer shell with plasma-sprayed coating and cobalt alloy metallic liner. Liner attaches to shell via taper mechanism; articulates with cobalt alloy modular heads. Used in orthopedic surgery for hip replacement; implanted by surgeons. Provides structural support and bearing surface for hip joint; facilitates joint mobility; corrects functional deformities; addresses degenerative disease and fractures. System allows for cemented or non-cemented fixation; includes screw holes in dome for additional fixation.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Titanium outer acetabular shell with plasma-sprayed coating; cobalt alloy metallic liner; hemispherical geometry; modular taper attachment; screw holes for fixation; cemented or non-cemented application.

Indications for Use

Indicated for patients requiring hip joint replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision of failed prior treatments, or proximal femur fractures (non-union, femoral neck, trochanteric) unmanageable by other techniques.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Metal on Metal Acetabular System (K993438)
• M2a™ 32mm Taper System (K003363)
• Mallory/Head PF Acetabular Component (K861114)

Submission Summary (Full Text)

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K042841 1/2

DEC 21 2004

## 510(k) Summary

Applicant/Sponsor:Biomet Manufacturing Corp.

Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist

Proprietary Name: M²a™/C²a™ Acetabular System

Common Name: Metallic Acetabular System

### Classification Name:

- 1. Hip joint metal/metal semi-constrained, with an uncemented acetabular component prosthesis (21 CFR 888.3330)
- 2. Hip joint metal/metal semi-constrained, with a cemented acetabular component prosthesis (21 CFR 888.3320)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet devices:

> K993438 - Metal on Metal Acetabular System K003363 - M2a™ 32mm Taper System K861114 - Mallory/Head PF Acetabular Component

Device Description: The M²a™/C²a™ Acetabular System consists of a titanium outer acetabular shell with a cobalt alloy metallic liner for metal articulation.

The acetabular shells are hemispherical in shape to closely match the natural acetabulum. Two screw holes in the dome allow for additional fixation by the use of screws. The outer surface of the shells are covered with Biomet's plasma sprayed coating.

The metallic cobalt alloy bearing liner fits into the outer shell by means of a taper similar to the taper used for the attachment of a modular head to a femoral stem. The metallic liners articulate with cobalt alloy modular heads.

| MAILING ADDRESS | P.O. Box 587 |
|------------------|-----------------------|
| | Warsaw, IN 46581-0587 |
| SHIPPING ADDRESS | 56 E. Bell Drive |
| | Warsaw, IN 46582 |
| OFFICE | |
| FAX | |

Warsaw, IN 46582

574 267 (1634)

574.267.8137

125

E-MAH. [e-mail]

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K012041

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M²a™/C²a™ Acetabular System 510(k) Summary Page 2

Intended Use: The Mªa™/C²a™ Acetabular System is intended for cemented or noncemented use in cases of:

- 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 2) Rheumatoid arthritis
- 3) Correction of functional deformity
- 4) Revision procedures where other treatment or devices have been unsuccessful
- 5) Treatment of non-union, femoral neck fracture, trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

Summary of Technologies: The technological characteristics of the new device are similar of identical to the predicates.

Non-Clinical Testing: None provided

Clinical Testing: None provided.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread, which is a common symbol of the United States. The eagle is stylized and appears to be in motion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2004

Ms. Patricia S. Andborn Beres Senior Regulatory Specialist 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46582

Re: K042841 Trade/Device Name: M2a / C2a™ Acetabular System Regulation Number: 888.3330; 888.3320 Regulation Name: Hip joint metal/semi constrained, with uncemented acetabular component prosthesis; Hip joint metal / metal semi-constrained acetabular component prosthesis Regulatory Class: III Product Code: KWA, JDL Dated: November 26, 2004 Received: November 29, 2004

Dear Ms. Andborn Beres:

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. Patricia S. Andborn Beres

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/dsma/dsmamain.html

Sincerely yours.

Alan Watt

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 (if known):

Device Name: M²a™/C²a™ Acetabular System

Indications For Use:

The M²a™/C²a™ Acetabular System is intended for cemented or non-cemented use in cases of:

- Cases of.
1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 2) Rheumatoid arthritis
- 3) Correction of functional deformity
- 5) Oorcollon of fancischer enothing
4) Revision procedures where other treatment or devices have been unsuccessful
- 4) Trevision procudios where earle recture, trochanteric fractures of the proximal frouthwith head involvement, unmanageable using other techniques

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

Over-The-Counter Use (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)

Alva Watts

Division of Genera Kerturative and Neurological Devices

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510(k) Namber_66