HA PMI FEMORAL HIP STEM

K030048 · Biomet Orthopedics, Inc. · LPH · Feb 5, 2003 · Orthopedic

Device Facts

• Record ID: K030048
• Device Name: HA PMI FEMORAL HIP STEM
• Applicant: Biomet Orthopedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 5, 2003
• 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

The HA PMI Femoral Hip Stem is a patient-specific, uncemented hip replacement prosthesis. It is designed to better fill the patient's natural femoral canal by modifying parameters such as A-P diameter, lateral flare, and posterior bowing. Because each stem is custom-matched to the patient's anatomy, the device is manufactured within a defined geometric envelope rather than as a standard off-the-shelf product. It is intended for use by orthopedic surgeons in a clinical/surgical setting to replace a diseased hip joint, potentially improving anatomical fit and patient outcomes. The device is implanted during primary hip replacement surgery.

Clinical Evidence

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

Technological Characteristics

Uncemented, porous-coated, semi-constrained hip joint prosthesis. Materials, design, and processing are identical or similar to the predicate device. The device is customized to patient anatomy within a defined geometric envelope.

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

• PMI Hip Femoral (K923452)

Submission Summary (Full Text)

{0}------------------------------------------------

K030048

BIOMET

## Summary of Safety and Effectiveness

Applicant/Sponsor:Biomet Orthopedics, Inc.

FEB 0 5 2003

Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist

Proprietary Name: HA PMI Femoral Hip Stem

Common Name: Hip replacement prosthesis

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

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The PMI Hip Femoral - 510(k) K923452.

Device Description: A surgeon will request a PMI hip stem over a standard line product in order to better fill the patient's natural femoral canal. The most common parameters modified include the expansion of the A-P diameter, the increase of the lateral flare of the device and the posterior bowing of the stem. The resulting device will more closely match the patient's natural anatomy. Since each stem is matched to a particular patient, a specific device description is unavailable. Instead, an envelope has been defined which all devices must fit.

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 PMI Hip Femoral Stems 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

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

■

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

.

OFFICE 574.267.6639

FAX [phone]

E-MAIL [e-mail]

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2003

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

Re: K030048

Trade/Device Name: HA PMI Femoral Hip 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 Codes: LPH, MEH Dated: January 2, 2003 Received: January 6, 2003

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.

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

{2}------------------------------------------------

## Page 2 - Ms. Patricia Sandborn Beres

systems (OS) 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 vour 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/dsma/dsmamain.html

Sincerely yours,

Sincerely, yours,

Mark N. Milkerson

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

{3}------------------------------------------------

510(k) Number (if known):

Device Name: HA PMI Hip Femoral Stems

## 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. Milkerso

Division Sis 2 % 31 Restorative and Neur

510(k) Number -

(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)

00:00