M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT

K062995 · Biomet Manufacturing Corp · KWA · Oct 31, 2006 · Orthopedic

Device Facts

• Record ID: K062995
• Device Name: M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
• Applicant: Biomet Manufacturing Corp
• Product Code: KWA · Orthopedic
• Decision Date: Oct 31, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The M2a-Magnum™ System is indicated for non-cemented use in patients requiring total hip replacement due to the following: - 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. - Rheumatoid arthritis - Correction of functional deformity - Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques - Revision of previously failed total hip arthroplasty

Device Story

M2a-Magnum™ Tri-Spike™ Acetabular Component is a Co-Cr-Mo metal-on-metal hip prosthesis component. Device features full hemisphere shell (44mm-66mm diameter) with porous plasma spray coating for biological fixation and three dome spikes for rotational stability. Used in total hip replacement surgery; implanted by orthopedic surgeons. Provides metal articulation surface for hip joint. Benefits include restoration of joint function and stability in patients with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Material: Co-Cr-Mo alloy. Form factor: Full hemisphere shell, 44mm-66mm outer diameter. Features: Porous plasma spray coating for biological fixation; three dome spikes for rotational stability. Intended for non-cemented use.

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 proximal femur fractures/non-union unmanageable by other techniques, and for 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™ System (K042037)

Submission Summary (Full Text)

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## 510(k) Summarv

OCT 3 1 2006

| Preparation Date: | September 22, 2006 |
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| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| Contact Person: | Patricia Sandborn Beres<br>Senior Regulatory Specialist |
| Proprietary Name: | M2a-Magnum™ Tri-SpikeTM Acetabular Component |

Common Name: Metal on metal acetabular component

Classification Code(s)/Name(s): 87 KWA - Hip joint metal/metal semi-constrained, with uncemented acetabular component prosthesis (21 CFR 888.3330)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: M2a-Magnum™ System, 510(k) K042037.

## Device Description:

The M2a-Magnum™ ™ Tri-Spike™ Acetabular Components is a Co-Cr-Mo, full hemisphere shell in outer diameters of 44mm to 66mm designed for metal articulation. The outer surface of the shell features porous plasma spray coating for biological fixation and three dome spikes for rotational stability.

Intended Use: The M2a-Magnum™ System is indicated for non-cemented use in patients requiring total hip replacement due to the following:

- 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.
- . Rheumatoid arthritis
- . Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- Revision of previously failed total hip arthroplasty

Summary of Technologies: The overall design, materials and processing methods are similar to the predicate device

## Non-Clinical Testing: None provided

Clinical Testing: None provided

All trademarks are property of Biomet, Inc.

| MAILING ADDRESS | P.O. Box 587<br>Warsaw, IN 46581 0587 |
|------------------|---------------------------------------|
| SHIPPING ADDRESS | 56 E. Bell Drive<br>Warsaw, IN 46582 |
| OFFICE | 574.267.6639 |
| FAX | 574.267.8137 |
| E-MAIL | [e-mail] |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Ms. Patricia Sandborn Beres Senior Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-1683

OCT 3 1 2006

Re: K062995 Trade/Device Name: M2a-Magnum™ Tri-Spike Acetabular Component Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with uncemented acetabular component Regulatory Class: Class III Product Code: KWA Dated: September 29, 2006 Received: October 02, 2006

Dear Ms. Sandborn 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 Sandborn 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson 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: _________________________________________________________________________________________________________________________________________________________________

Indications For Use: The M2a-Magnum™ System is indicated for non-cemented use in patients requiring total hip replacement due to the following:

- 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.
- Rheumatoid arthritis
- . Correction of functional deformity
- . Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- � Revision of previously failed total hip arthroplasty

Prescription Use (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) | |
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Pep

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K062997 Page 1 of 1

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