BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS

K082446 · Biomet, Inc. · KWA · Oct 15, 2008 · Orthopedic

Device Facts

• Record ID: K082446
• Device Name: BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
• Applicant: Biomet, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Oct 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

K993438, K011110, K042037, K043537, K061423, K062995: 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 using other techniques. 5. Revision of previously failed total hip arthroplasty. K002379, K003363: 1. Noninflammatory 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 failed. 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Device Story

Biomet Metal-on-Metal Hip Systems consist of acetabular cups, femoral heads, adapters, and inserts; Co-Cr-Mo head articulates with Co-Cr-Mo surface. Device used in orthopedic surgery for total hip arthroplasty. This submission specifically expands contraindications to include patients with chronic renal failure and patients who are pregnant or may become pregnant. No changes to device design, materials, or technology.

Clinical Evidence

No clinical data provided as a basis for substantial equivalence.

Technological Characteristics

Co-Cr-Mo metal-on-metal articulation; includes acetabular cups, femoral heads, adapters, and inserts. Identical to predicate devices in materials, design, and sizing.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis, traumatic arthritis), rheumatoid arthritis, functional deformity, non-union, femoral neck/trochanteric fractures, or revision of failed total hip arthroplasty. Contraindicated in patients with chronic renal failure and patients who are pregnant or may become pregnant.

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

• Metal-on-Metal Acetabular System (K993438)
• M2a™ 28mm RingLoc™ Liner (K002379)
• M2a™ 32mm Taper System (K003363)
• M2a™ Acetabular System (K011110)
• M2a-Maqnum™ System (K042037)
• TaperLoc® 12/14 Femoral Components and One-Piece Modular Heads (K043537)
• M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads (K061423)
• M2a-Magnum™ Tri-Spike™ Acetabular Component (K062995)

Submission Summary (Full Text)

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K082446

OCT 1 5 2008

Image /page/0/Picture/2 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized font with a registered trademark symbol. Below the logo is the text "MANUFACTURING CORP".

# 510(k) Summary

October 7, 2008 Preparation Date:

- Applicant/Sponsor: Biomet Manufacturing Corp.
- Contact Person: Becky Earl

Proprietary Name: Biomet® Metal on-Metal Hip Systems-Expanded Contraindications

- Common Name: Hip prosthesis, metal-on-metal articulation
Classification Name: Class III (Preamendment), 21 CFR §888.3330, KWA

- KWA- Hip joint metal/metal semi-constrained, with uncemented acetabular component prosthesis .
#### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Metal-on-Metal Acetabular System-K993438 (Biomet, Inc.) M2a™ 28mm RingLoc™ Liner-K002379 (Biomet, Inc.) M2a™ 32mm Taper System-K003363 (Biomet, Inc.) M2a™ Acetabular System-K011110 (Biomet, Inc.) M2a-Maqnum™ System-K042037 (Biomet, Inc.) TaperLoc® 12/14 Femoral Components and One-Piece Modular Heads-K043537 (Biomet, Inc.) M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads-K061423 (Biomet, Inc.) M2a-Magnum™ Tri-Spike™ Acetabular Component-K062995 (Biomet, Inc.)

## Device Description:

The systems consist of acetabular cups, femoral heads, and adapters and inserts. The Co-Cr-Mo head articulates with Co-Cr-Mo.

## Indications for Use/Intended Use:

K993438, K011110, K042037, K043537, K061423, K062995:

- 1. Non-inflammatory degenerative ioint 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 using other techniques.
- 5. Revision of previously failed total hip arthroplasty.

Mailing Address: P.O Box 587 Wars w IN 46581 0587 Toll Free: 800 3-18 9500 Office: 574 257 6839 Main Fax: [phone] www.blomel.com

Shipping Address: 60 East Bell Drive Warsaw, IN 46582

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## 510(k) Summary Biomet® Metal-on Metal Hip Systems - Expanded Contraindications Biomet Manufacturing Corp. Page 2 of 2

#### K002379, K003363:

- 1. Noninflammatory 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 failed.
- 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Contraindications have been expanded to include patients with chronic renal failure and patients who are pregnant or may become pregnant.

#### Summary of Technologies:

The technological characteristics (materials, design, sizing, and indications) of the Biomet® Metal-on-Metal Hip Systems-Expanded Contraindications are identical to the predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing is not provided as a basis for substantial equivalence.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

OCT 1 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K082446

Trade/Device Name: Biomet® Metal-on-Metal Systems- Expanded Contraindications Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA Dated: August 20, 2008 Received: August 25, 2008

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 (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 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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Wilkerson

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

-082446 510(k) Number (if known):

Device Name: Biomet® Metal-on-Metal Hip Systems-Expanded Contraindications

# Indications for Use/Intended Use:

K993438, K011110, K042037, K043537, K061423, K062995:

- 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 using other techniques.
- 5. Revision of previously failed total hip arthroplasty.

K002379, K003363:

- 1. Noninflammatory 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 failed.
- 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

| Prescription Use X | AND/OR | Over-The-Counter Use NO |
|-----------------------------|--------|-------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) |

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

Nal R firm
Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K082446

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