M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS

K061423 · Biomet Manufacturing Corp · KWA · Jul 27, 2006 · Orthopedic

Device Facts

• Record ID: K061423
• Device Name: M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
• Applicant: Biomet Manufacturing Corp
• Product Code: KWA · Orthopedic
• Decision Date: Jul 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are intended for use in patients requiring total hip replacement due to the following: 1. Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision of previously failed total hip arthroplasty.

Device Story

Modular hip prosthesis components; includes 12/14 taper inserts and one-piece modular heads. Designed for use with TaperLoc 12/14 taper femoral components and M2a Magnum system articulating shells. Inserts provide neck offsets (-6mm to +9mm); mate with modular heads (38mm-60mm diameters). Used in total hip replacement surgery; implanted by orthopedic surgeons. Provides articulating surface for hip joint; restores joint function; addresses degenerative disease, arthritis, and revision needs.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Modular hip prosthesis components. Materials, design, and articulating surfaces are identical to predicate systems. Designed for uncemented applications. Features 12/14 taper interface for femoral component compatibility.

Indications for Use

Indicated for patients requiring total hip replacement due to non-inflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis, traumatic arthritis), rheumatoid arthritis, functional deformity, or treatment of non-union/fractures of the proximal femur, and revision of failed total hip arthroplasty.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented 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. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• M2a Magnum™ Systems (K042037)
• ASR™ Modular Acetabular Cup System (K040627)
• TaperLoc® 12/14 Taper Femoral Components (K043537)

Submission Summary (Full Text)

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K061423 (Pg 1 of 2)

Image /page/0/Picture/1 description: The image shows the logo for Biomet Orthopedics Inc. The logo consists of the word "BIOMET" in a bold, sans-serif font, with the letters connected to form a single block. Below the word "BIOMET" is the phrase "ORTHOPEDICS INC." in a smaller, serif font. The logo is simple and modern, and it is likely used to represent the company's brand.

**JUL 27 2006**

## 510(k) Summarv

Preparation Date: May 19, 2006

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Becky Earl, Regulatory Specialist

Proprietary Name: M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads

Common Name: metal-on-metal inserts and modular heads

Classification Name: Hip joint metal/metal semi-constrained, with uncemented acetabular component prosthesis (888.3330)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: M2a Magnum™ Systems-K042037 (Biomet, Inc.); ASR™ Modular Acetabular Cup System-K040627 (DePuy Orthopaedics, Inc.), and TaperLoc® 12/14 Taper Femoral Components-K043537 (Biomet, Inc.).

Device Description: The M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are designed for use with the Taper oc 12/14 taper femoral components and the articulating heads and shells of the M2a Maqnum™ Sytem (K043537) for uncemented applications.

There are two sets of taper inserts, each providing neck offsets from to +9mm. The first set has a smaller diameter and mates with modular head sizes 42mm. The second set of taper inserts has a larger outer diameter and mates with modular head sizes 52mm through 60mm. The one-piece 12/14 modular head sizes will include 38mm and 40mm outer diameters. Available neck offsets will range from -6mm to +9mm.

## Intended Use:

The M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are intended for use in patients requiring total hip replacement due to the following:

- 1. Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis.
- 2. Rheumatoid arthritis.
- 3. Correction of functional deformity.
- 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- 5. Revision of previously failed total hip arthroplasty.

Summary of Technologies: The technological characteristics (materials, design, sizing, articulating surface, indications) of the M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are similar or identical to the predicate devices.

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

SHIPPING ADDRESS 56 E Boll Drive Warsaw, IN 46582

OFFICE 574.267.6639

FAX
574.267.8137

E-MAIL [e-mail]

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K061423 (pg 2 of 2)

## Page 2 of 2 r uge = = = = Biomet Manufacturing Corp.

Non-Clinical Testing: Non-clinical laboratory testing had been previously 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.

All trademarks are property of Biomet, Inc. except for ASR™ Modular Acetabular Cup System (DePuy Orthopaedics, Inc.)

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text around the perimeter appears to be the name of an organization or agency. The central graphic consists of three curved lines that resemble a bird in flight or a stylized representation of human figures. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 7 2006

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

Re: K061423

Trade/Device Name: M2a Magnum™ 12/14 Taper Inserts and One--Piece Modular Heads Regulation Number: 21 CFR 888.3330

Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component prosthesis

Regulatory Class: Class III Product Code: K.WA Dated: May 22, 2006 Received: May 23, 2006

Dear Ms. Earl:

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.

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

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Page 2 - Ms. Becky Earl

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.

Hubertus

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): YOG1423

Device Name: M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads

Indications For Use:

The M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are indicated for use in patients requiring total hip replacement due to the following:

- 1. Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis.
- 2. Rheumatoid arthritis.
- 3. Correction of functional deformity.
- 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanaqeable by other techniques.
- 5. Revision of previously failed total hip arthroplasty.

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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(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K061423