HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS

K023409 · Biomet, Inc. · LPH · Nov 8, 2002 · Orthopedic

Device Facts

• Record ID: K023409
• Device Name: HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
• Applicant: Biomet, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Nov 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.

Device Story

HA X-Series Bi-Metric Hip Femoral Components are orthopedic implants for total hip replacement; designed for uncemented, non-inflammatory degenerative joint disease treatment. Device consists of femoral stem with hydroxyapatite (HA) coating to enhance tissue adherence. Implanted by surgeons in clinical settings. HA coating promotes biological fixation to bone. Substantially equivalent to predicate X-Series Bi-Metric Hip Femoral Component (K020580), with modification limited to addition of HA coating.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by mechanical testing and engineering analysis.

Technological Characteristics

Hip joint metal/polymer/metal semi-constrained, porous-coated, uncemented prosthesis. Features hydroxyapatite (HA) coating on femoral stems. Materials, design, and sizing are identical to predicate device.

Indications for Use

Indicated for skeletally mature patients undergoing primary hip replacement surgery due to non-inflammatory degenerative joint disease.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• X-Series Bi-Metric® Hip Femoral Component (K020580)

Submission Summary (Full Text)

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8 2002 NOV

23409

BIOMET

page 10 of 11

## Summary of Safety and Effectiveness

Applicant/Sponsor:Biomet Orthopedics, Inc.

Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist

Proprietary Name: HA X-Series Bi-Metric® Hip Femoral Components

Common Name: Total Hip Replacement

Classification Name: Hip joint metal/polmer/metal semi-constrained, porouscoated, uncemented prosthesis (21 C.F.R. 888.3358)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: X-Series Bi-Metric® Hip Femoral Component (K020580)

Device Description: The HA X-Series Bi-Metric® Hip Femoral Components consist of the same design and materials as the predicate devices contained in 510(k) K020580 except that the stems have been further coated with hydroxyapatitie (HA) coating. The HA coating has been added to enhance tissue adherence.

Intended Use: Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative ioint disease.

Summary of Technologies: The HA X-Series Bi-Metric® Hip Femoral Components are similar to or identical in materials, design, sizing and processing to the predicate device.

Non-Clinical Testing: Mechanical testing and engineering analysis has justified the modifications to this device.

Clinical Testing: None provided

Bi-Metric is a trademark of Biomet, Inc.

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MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

1

OFFICE 574.267.6639

FAX [phone]

E-MAIL [e-mail]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 8 2002

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K023409

Trade/Device Name: HA X-Series Bi-Metric® Femoral Stems 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: LPH, MEH Dated: October 8, 2002 Received: October 10, 2002

Dear Ms. 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.

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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 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.

Mark n Milherm

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):** k023409

## Device Name: HA X-Series Bi-Metric® Femoral Components

## Indications For Use:

Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.

Mark A. Millhurn

Tivision Sign-Of D ision of General, Restorative and Neurological Devices

510(k) Number K023407

(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)

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