X-SERIES BI-METRIC HIP FEMORAL COMPONENTS

K020580 · Biomet, Inc. · LPH · Mar 22, 2002 · Orthopedic

Device Facts

• Record ID: K020580
• Device Name: X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
• Applicant: Biomet, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Mar 22, 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

X-Series Bi-Metric femoral components are hip replacement prostheses; intended for non-cemented primary hip arthroplasty. Device inputs include patient anatomical requirements; device functions as a structural replacement for the femoral head/neck. Modifications from predicate include an oblong insertion hole for improved surgical control, increased horizontal offsets, and a 130° neck angle (vs 135°). Used by orthopedic surgeons in clinical/OR settings. Output is a physical implant providing joint stability and mobility for patients with degenerative joint disease.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V) per ASTM F-620. Design: Uncemented, porous-coated femoral component. Features: Oblong insertion hole, 130° neck angle, lateralized style with increased horizontal offsets.

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

• Bi-Metric® Hip Femoral Component (K921224)

Submission Summary (Full Text)

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MAR 2 2 2002

K020580

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## Summary of Safety and Effectiveness

Applicant/Sponsor: Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Patricia Sandborn Beres Contact Person: Senior Requlatory Specialist Phone: [phone]

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

Common Name: Hip replacement prosthesis

Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, porous coated uncemented (888.3558

Legally Marketed Device to which Substantial Equivalence is Claimed: Bi-Metric® Hip Femoral Component (K921224)

Device Description: The X-Series Bi-Metric® femoral components are identical to the predicate Bi-Metric® femoral components in overall geometry. Both device series are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-620. The stem diameters and lengths are identical. An oblong insertion hole replaces the predicate round insertion hole in order to provide the surgeon with more control during insertion.

For the new lateralized style, the difference in the two series lies in the horizontal offsets and neck angle. The offset is increased and therefore the distance from the center of the modular head to the center of the stem is also increased. The taper trunion or post is angled at 130° on the modified device whereas the post of the predicate device is at 135°.

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

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

FAX [phone]

E-MAIL [e-mail]

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

Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the X-Series Bi-Metric femoral components are similar to or identical to the predicate device.

Non-Clinical Testing: Mechanical testing was conducted to insure the design changes would not effect the safety of the device.

Clinical Testing: None provided

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AR 2 2 2002

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

Re: K020580

Trade/Device Name: X-Series Bi-Metric® Hip Femoral Components 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 Dated: February 20, 2002 Received: February 21, 2002

Dear Ms. Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becament of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suned in the encreat 1976, the enactment date of the Medical Device Amendments, or to conninered prior to rial) 2011-07-2017 accordance with the provisions of the Federal Food, Drug, de nees mat have been route 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 I ou may, arorely mains 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 If your device is classinod (too arotrols. Existing major regulations affecting your device can may or buyer to back are are are are and 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 nean r rouse be actived and i bromination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 Of R Part 8077, acomig (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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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.

R. Mch. A. Mchllum

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

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510(k) Number (if known): __ KO20580

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

#### Indications For Use:

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

Madk.M.Melle

(Division Sign-Off) Division of General, Res rative and Neurological Devices KO2OSBU

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 801709)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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