HA PMI FLANGED ACETABULAR COMPONENT

K030861 · Biomet, Inc. · LPH · Jun 12, 2003 · Orthopedic

Device Facts

• Record ID: K030861
• Device Name: HA PMI FLANGED ACETABULAR COMPONENT
• Applicant: Biomet, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jun 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HA PMI Flanged Acetabular Component is indicated for use in patients requiring reconstruction of the hip joint due to disease, deformity or trauma. The device is intended for cementless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. The device is a single use implant. The device is to be used in conjunction with any commercially available femoral component.

Device Story

Patient-matched acetabular component designed for cases of unusual anatomy or extensive bone loss; provides stability via additional screw fixation in flanges compared to standard hemispherical components. Implanted by surgeons in clinical settings; used in conjunction with commercially available femoral components. Benefits patients by providing customized anatomical fit for hip joint rehabilitation.

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. Patient-matched design for cementless application.

Indications for Use

Indicated for skeletally mature patients requiring hip joint reconstruction due to disease, deformity, or trauma; intended for cementless application.

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 Flanged Acetabular Component (K983035)

Submission Summary (Full Text)

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K 03086/

JUN 1 2 2003

## Summary of Safety and Effectiveness

Applicant/Sponsor:Biomet Orthopedics, Inc.

Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist

Proprietary Name: HA PMI Flanged Acetabular Component

Common Name: Hip replacement acetabular prosthesis

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: PMI Flanged Acetabular Component - 510(k) K983035

Device Description: A surgeon will request a PMI device over a standard line product in order to better fill the patient's natural anatomy. For example, a Patient Matched Flanged Acetabular Component might be requested in cases of unusual anatomy or extensive bone loss. In such cases, a hemispherical acetabular component, which only has the option of screw fixation in the socket area, may not provide stability that can be obtained through additional screw fixation in the flanges.

Since each cup is matched to a particular patient, a specific device description is unavailable.

Intended Use: The HA PMI Flanged Acetabular Component is indicated for use in patients requiring reconstruction of the hip joint due to disease, deformity or trauma. The device is intended for cementless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. The device is a single use implant. The device is to be used in conjunction with any commercially available femoral component.

Summary of Technologies: The HA PMI Flanged Acetabular 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

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

.

OFFICE 574.267.6639

FAX [phone]

E-MAIL [e-mail]

SHIPPING ADDRESS

56 E. Bell Drive

Warsaw, IN 46582

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 2 2003

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

Re: K030861

Trade/Device Name: HA PMI Flanged Acetabular Component Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: March 17, 2003 Received: March 18, 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

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# Page 2 - Ms. Patricia Sandborn Beres

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), 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 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,

O. Mark N. Millerson

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):

Device Name: HA PMI Flanged Acetabular Component

### Indications For Use:

The HA PMI Flanged Acetabular Component is indicated for use in patients requiring reconstruction of the hip joint due to disease, deformity or trauma. The device is intended for cementless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. The device is a single use implant. The device is to be used in conjunction with any commercially available femoral component.

(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)

for Mark A. Mulkerson

Division Sign-Off) is on of Cieveral, Restorative and Mourological Devices

510(k) Number

Over-The-Counter Use

(Optional Format 1-2-98)