XR-SERIES BI-METRIC FEMORAL COMPONENTS

K052089 · Biomet Manufacturing, Inc. · LPH · Feb 17, 2006 · Orthopedic

Device Facts

• Record ID: K052089
• Device Name: XR-SERIES BI-METRIC FEMORAL COMPONENTS
• Applicant: Biomet Manufacturing, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XR-Series Bi-Metric® Femoral Components are intended for cemented or uncemented use in cases of: 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 by other techniques. 5) Revision of previously failed total joint replacement.

Device Story

XR-Series Bi-Metric femoral components are hip joint replacement prostheses; used in cemented or uncemented procedures. Device geometry is identical to predicate Bi-Metric X-Series; features titanium alloy (Ti-6Al-4V) construction; includes expanded product offering with reduced proximal profile devices; trapezoidal, polished neck design. Implanted by orthopedic surgeons in clinical/OR settings to replace diseased or fractured femoral heads; restores joint function; alleviates pain; improves patient mobility. Mechanical testing performed to ensure safety of design modifications.

Clinical Evidence

No clinical data provided. Safety supported by mechanical bench testing.

Technological Characteristics

Titanium alloy (Ti-6Al-4V) per ASTM F-620. Semi-constrained porous-coated uncemented prosthesis. Trapezoidal, polished neck. Dimensions (stem diameters/lengths) identical to predicate. Class II device.

Indications for Use

Indicated for patients requiring hip joint replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or proximal femur fractures (non-union, femoral neck, trochanteric) unmanageable by other techniques, and for revision of failed total joint replacements.

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 X-Series Hip Femoral Components (K020580, K030055)

Submission Summary (Full Text)

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FEB 1 7 2006

K052089

## 510(k) Summary

| Applicant/Sponsor: | Biomet Manufacturing Corp. |
|----------------------|---------------------------------------------------------|
| Contact Person: | Patricia Sandborn Beres<br>Senior Regulatory Specialist |
| Proprietary Name: | XR-Series Bi-Metric® Femoral Components |
| Common Name: | Hip joint replacement device |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous |

coated יות מש uncemented prosthesis.

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Bi-Metrix® X-Series Hip Femoral Components, originally cleared by 510(k) K020580, 03/22/02 and cleared for expanded indications by 510(k) K030055, 8/11/03.

Device Description: The XR-Series Bi-Metric® femoral components are identical to the predicate Bi-Metric® X-Series 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. The product offering has been expanded to include reduced proximal profile devices. All devices have a trapezoidal, polished neck.

Intended Use: The XR-Series Bi-Metric® Femoral Components are intended for cemented or uncemented use in cases of:

- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 1)
- 2) Rheumatoid arthritis
- Correction of functional deformity 3)
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal 4) femur with head involvement, unmanageable by other techniques.
- 5) Revision of previously failed total joint replacement.

Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the XR-Series Bi-Metric® Femoral Components are similar to or identical to the predicate device or other previously cleared devices.

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

Clinical Testing: None provided

Date Prepared: January 30, 2006

All trademarks are property of Biomet, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2006

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

Re: K052089

Trade/Device Name: XR-Series Bi-Metric Femoral Components Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Codes: LPH, JDI, LZO, KWY, KWZ, Dated: February 1, 2006 Received: February 2, 2006

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 for ass stated in 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 r va may, ateres, 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 11 your de rise is onable (in al controls. Existing major regulations affecting your device can may or datyed to battle to begulations, 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 i read on a made a determination that your device complies with other requirements of the Act that + Dr daral statutes and regulations administered by other Federal agencies. You must or uny I oderal battler and 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 forth in the quality bysteins (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) This letter will anow you to ocgin mailiemlig of substantial equivalence of your device to a legally premarket notification: "The Price is 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 rryou desire specific as no liance at [phone]. Also, please note the regulation entitled, Coliable of Collied of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Herbert Leuer 19

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K052089

Device Name: XR-Series Bi-Metric® Femoral Components

Indications For Use: The XR-Series Bi-Metric® Femoral Components are intended for cemented or uncemented use in cases of:

- cemented of uncemented use in odood on
1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 2) Rheumatoid arthritis
- 3) Correction of functional deformity
- 3) Correction of functional dolormis)
4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the Treatment of non anion, fornerament, unmanageable by other techniques.
- 5) Revision of previously failed total joint replacement.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |

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