TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM

K020963 · Biomet Orthopedics, Inc. · MEH · Apr 16, 2002 · Orthopedic

Device Facts

• Record ID: K020963
• Device Name: TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
• Applicant: Biomet Orthopedics, Inc.
• Product Code: MEH · Orthopedic
• Decision Date: Apr 16, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HA Taperloc® Porous Femoral Stem & HA Taperloc® Porous Lateralized Femoral Stem are indicated for use for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 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; and 5) Revision procedures where other treatments or devices have failed.

Device Story

HA Taperloc® Porous Femoral Stems are uncemented prosthetic hip joint components. Device consists of femoral stem with hydroxyapatite (HA) coating applied to porous surface. Used in orthopedic surgery to replace diseased or damaged hip joints. Operates as mechanical implant to restore joint function. Surgeon implants device into femur. HA coating promotes osseointegration. Benefits include improved fixation and joint stability for patients with degenerative joint disease, arthritis, or fractures.

Clinical Evidence

No clinical data provided. Substantial equivalence based on mechanical testing and engineering justification.

Technological Characteristics

Uncemented femoral stem prosthesis; metal/polymer construction; hydroxyapatite (HA) coating on porous surface; various sizes; intended for semi-constrained hip joint replacement.

Indications for Use

Indicated for patients requiring hip arthroplasty due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (non-union, femoral neck, trochanteric with head involvement), or revision procedures.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Taperloc® Femoral Stem (K921301)

Submission Summary (Full Text)

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K020963

# APR 1 6 2002

Image /page/0/Picture/2 description: The image shows the logo for BIOMET CORPORATE HEADQUARTERS. The word BIOMET is in a stylized font with thick, black lines. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, sans-serif font.

### SUMMARY OF SAFETY AND EFFECTIVENESS

Biomet Orthopedics, Inc. Applicant or Sponsor: 56 East Bell Drive Warsaw, IN 46581-0587

Contact Person: Dalene T. Binkley Telephone: [phone]

Proprietary Name: HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems

Common Name: Prosthetic Hip Joint - Hydroxyapatite (HA) Coated Porous Femoral Stem

Classification: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, nonporous, calcium-phosphate

Device Classification: Class II

Legally Marketed Device to which Substantially Equivalence is Claimed: Taperloc® Femoral Stem (K921301)

Device Description: The HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems are the same as the predicate Taperloc® Femoral Stem (K921301), except for the additions of Hydroxyapatite Coating and additional sized femoral stems.

Indications for Use: The indications for the HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems are for ) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 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; and 5) Revision procedures where other treatments or devices have failed.

Summary of Technologies: The HA Taperloc® Porous Femoral Stems & HA Taperioc® Porous Lateralized Femoral Stems' components-the materials, design, sizing, and indications are similar or identical to the predicate devices.

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

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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ORFICE 219.267.6639

FAX [phone]

E-MAIL [e-mail]

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Non-Clinical Testing: Mechanical Testing with an Engineering Justification determined that the HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems' components presented no new risks and were, therefore, substantially equivalent to the predicate device.

Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 6 2002

Ms. Dalene Binkley Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K020963

Trade Name: HA Taperloc® Porous Femoral Stem & HA Taperloc® Porous Lateralized Femoral Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MEH Dated: March 22, 2002 Received: March 25, 2002

Dear Ms. Binkley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Dalene Binkley

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Sincerely yours,

Mark A. Millhussen

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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## 510 (k) NUMBER (IF KNOWN): _ k 02096 3

DEVICE NAME: HA Taperloc® Porous Femoral Stem & HA Taperloc® Porous Lateralized Femoral Stem

### INDICATIONS FOR USE:

The HA Taperloc® Porous Femoral Stem & HA Taperloc® Porous Lateralized Femoral Stem are indicated for use for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 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; and 5) Revision procedures where other treatments or devices have failed.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Mark N Millham

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

510(k) Number _

0000