HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM

K021403 · Biomet Orthopedics, Inc. · MEH · May 31, 2002 · Orthopedic

Device Facts

• Record ID: K021403
• Device Name: HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM
• Applicant: Biomet Orthopedics, Inc.
• Product Code: MEH · Orthopedic
• Decision Date: May 31, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for the HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems are 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

Prosthetic hip joint components; uncemented femoral stems; intended for total hip arthroplasty. Device consists of porous-coated femoral stem with hydroxyapatite (HA) coating. Used by orthopedic surgeons in clinical/hospital settings. Functions as structural replacement for proximal femur; HA coating promotes biological fixation to bone. Output is physical implant; aids in restoring joint function and mobility. Benefits patients by addressing degenerative disease, fractures, and revision needs.

Clinical Evidence

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

Technological Characteristics

Uncemented, semi-constrained hip prosthesis. Materials: metal/polymer with hydroxyapatite (HA) coating. Design: porous-coated femoral stem. Connectivity: N/A. Sterilization: Not specified.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or proximal femur fractures (non-union, femoral neck, trochanteric) requiring surgical intervention, including 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

• Mallory/Head® Porous Femoral Stem (K921181)
• Mallory/Head® Lateralized Press-Fit Femorals (K000538)
• Mallory/Head® Lateralized Press-Fit Femorals (K003429)

Submission Summary (Full Text)

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CORPORA RTERS

### SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:

Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587

Contact Person:

Dalene T. Binkley Telephone: [phone]

Proprietary Name: HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem

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: Mallory/Head® Porous Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429.

Device Description: The HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems are the same as each of their predicate(s)- Mallory/Head® Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429, except for the addition of Hydroxyapatite Coating and additional sizes for the standard femoral stems.

Indications for Use: The indications for the HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® 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.

> 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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00100

OFFICE 219.267.6639

FAX [phone]

E-MAIL [e-mail]

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001.09

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

Non-Clinical Testing: Mechanical Testing with an Engineering Justification determined that the HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® 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 seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 31 2002

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

Re: K021403

Trade/Device Name: HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® 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: II Product Code: MEH, LPH Dated: April 26, 2002 Received: May 2, 2002

Dear Ms. Binkley:

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. Dalene T. Binkley

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to obgin manisang your device of your device to a legally premaired 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 II you desire specific acrited to: your avitro diagnostic devices), please contact the Office of additionally 21 CHC Fart 607.10 for his raily, for questions on the promotion and advertising of Compliance at [phone] - 1550 - 155ce of Compliance at [phone]. Also, please note the your device, prease connecting by reference to premarket notification" (21CFR Part 807.97). It guiation entitued, "Nilostanang oresponsibilities under the Act may be obtained from the Outcl general information on your step 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,

R. Mark H. Millman

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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Page **_ of _**

# 510 (k) NUMBER (IF KNOWN): _ K O 21 4 v 3

DEVICE NAME: HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem

#### INDICATIONS FOR USE:

The HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® 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

KO21403

Over-The-Counter-Use \$\underline{No}\$
(Optional Format 1-2-96)

Mark n Milkesen

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

510(k) Number_

00009