RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM

K023085 · Biomet Orthopedics, Inc. · JDI · Oct 17, 2002 · Orthopedic

Device Facts

• Record ID: K023085
• Device Name: RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM
• Applicant: Biomet Orthopedics, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Oct 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for the Rx 90™ Femoral Stems and Rx 90™ 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. This device is to be used with bone cement.

Device Story

Metallic total hip femoral component; intended for cemented fixation in hip arthroplasty. Modifications to predicate include lateralized version, additional sizes, smaller stem, reduced collar, and smooth finish. Device implanted by orthopedic surgeons in clinical/hospital settings to replace diseased or damaged femoral head/neck. Provides structural support for hip joint; restores function; alleviates pain associated with degenerative joint disease or fractures. Mechanical properties verified via bench testing.

Clinical Evidence

No clinical testing was provided as a basis for substantial equivalence; bench testing only.

Technological Characteristics

Metallic total hip femoral component; semi-constrained cemented prosthesis. Materials, design, and sizing are similar to predicate. Intended for use with bone cement.

Indications for Use

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

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Rx 90™ Femoral Components (K924028)

Submission Summary (Full Text)

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K 023085 page 14

OCT 1 7 2002

# SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor: Biomet Orthopedics, Inc.

Dalene T. Binkley Contact Person:

Proprietary Name: Rx 90TM Femoral Stems and Rx 90™ Lateralized Femoral Stems

Common Name: Metallic total hip femoral component

Classification: Hip joint metal/polymer/metal semi-constrained cemented prosthesis

Device Classification: Class II

Legally Marketed Device to which Substantially Equivalence is Claimed: Rx 90™ Femoral Components- 510(k) K924028

Device Description: The Rx 90™ Femoral Components have been modified to include, not only a lateralized version to expand its product line, but also additional sizes including a smaller stem, a reduced collar and a "smooth" finish.

Indications for Use: The indications for the Rx 90™ Femoral Stems and Rx 90™ 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.

Summary of Technologies: The Rx 90™ Femoral Stems and Rx 90™ Lateralized Femoral Stems' components-the materials, design, sizing, and indications are similar or identical to the predicate devices.

Non-Clinical Testing: Mechanical testing was provided to demonstrate that the modifications do not effect the mechanical properties of the device.

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

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

SHIPPING ADDRESS 56 E. Bell Drive Warsaw. IN 46582

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FAX [phone]

E-MAIL [e-mail]

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 7 2002

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

Re: K023085

Trade/Device Name: Rx-90™ Femoral Stem and Rx-90™ Lateralized Femoral Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Cemented Prosthesis Regulatory Class: II Product Code: JDI Dated: September 16, 2002 Received: September 17, 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) 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 A. 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

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Page **_ of _**

510 (k) NUMBER (IF KNOWN): K023085

DEVICE NAME: Rx 90™ Femoral Stem and Rx 90™ Lateralized Femoral Stem

INDICATIONS FOR USE:

The indications for the Rx 90™ Femoral Stems and Rx 90™ 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.

This device is to be used with bone cement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use UK (Per 21 CFR 801.109)

OR

Over-The-Counter-Use No
(Optional Format 1-2-96)

for Mark A. Milleson
Division Sign Off

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

510(k) Number K02309

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