ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS

K051411 · Biomet, Inc. · LZO · Jun 29, 2005 · Orthopedic

Device Facts

• Record ID: K051411
• Device Name: ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS
• Applicant: Biomet, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jun 29, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity 4) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) Revision of previously failed total hip arthroplasty. Intended for cemented and uncemented applications

Device Story

Modular hip prosthesis system consisting of ArComXL polyethylene acetabular liners and Biolox delta ceramic femoral heads; intended for total hip arthroplasty. Ceramic head attaches to metallic femoral stem via Biomet Type I taper; highly polished spherical head articulates with polyethylene liner. Used in orthopedic surgery for joint replacement; provides bearing surface for hip joint. Benefits include reduced wear compared to previous components; facilitates treatment of degenerative joint disease, fractures, and revision cases. System allows combination of previously cleared components.

Clinical Evidence

No clinical data provided. Bench testing included volumetric wear testing showing reduced wear for the combined ArComXL and Biolox delta components.

Technological Characteristics

ArComXL liners: highly cross-linked polyethylene (ASTM F648). Biolox delta heads: Transition-Toughened-Platelet-Alumina (TTPA) ceramic. Modular design; Biomet Type I taper connection. Cemented or uncemented application.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (femoral neck/trochanteric) with head involvement, or revision of failed total hip arthroplasty.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• ArComXL Acetabular Liners (K042051)
• Biolox delta Ceramic Heads (K042091)

Submission Summary (Full Text)

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JUN 2 9 2005

## 510(k) Summary

| Sponsor: | Biomet Manufacturing Corporation<br>56 East Bell Drive<br>P.O. Box 587<br>Warsaw, IN 46581-0587 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tracy Bickel Johnson, RAC |
| Proprietary Name: | ArComXLTM Acetabular Liners and Biolox® delta Ceramic Heads |
| Common Name: | Acetabular liners and ceramic heads |
| Classification Name: | LZO- hip joint/ceramic/polymer, semi-constrained, cemented or non-<br>cemented prosthesis (888.3353) |
| Substantially Equivalent Devices: | ArComXLTM Acetabular Liners (K042051)<br>Biolox® delta Ceramic Heads (K042091) |
| Device Description: | The ArComXLTM polyethylene liners are manufactured from highly cross-<br>linked polyethylene conforming to ASTM F648 that was previously cleared in<br>K042051. ArComXLTM is available in three designs: MaxRom, Hi-Wall, and<br>10o. |
| | Biolox® delta Ceramic Heads (K042091) are composed of Transition-<br>Toughened-Platelet-Alumina (TTPA). The highly polished spherical surface<br>articulates with the ArComXLTM polyethylene liner acetabular component.<br>The modular head attaches to a metallic femoral stem with a Biomet Type I<br>taper. |
| Indications for Use: | 1) Non-inflammatory degenerative joint disease including osteoarthritis and<br>avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional<br>deformity 4) Treatment of nonunion, femoral neck and trochanteric<br>fractures of the proximal femur with head involvement, unmanageable<br>using other techniques, 5) Revision of previously failed total hip<br>arthroplasty. |
| | Intended for cemented and uncemented applications |
| Summary of Technologies: | The design, sizes, intended use, indications, contraindications, and<br>design specifications of the subject components remain identical to<br>their predicate component counterparts. This submission allows the<br>ArComXLTM Acetabular Liners and the Biolox® delta Ceramic Heads<br>to be used together. |
| Non-Clinical Testing: | Volumetric wear testing was performed on ArComXLTM Acetabular Liners<br>and the Biolox® delta Ceramic Liners showing less wear. |
| Clinical Testing: | None provided as a basis for substantial equivalence. |

All trademarks are property of Biomet, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human figures.

JUN 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms.Tracy Bickel Johnson Manager of Regulatory Affairs Biomet Incorporated P.O. Box 587 Warsaw, Indiana 46582

Re: K051411

Trade/Device Name: ArComXL™ Acetabular Liners and Biolox® delta Ceramic Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: May 27, 2005 Received: May 31, 2005

Dear Ms. Johnson:

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.Tracy Bickel Johnson

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 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/industry/support/index.html.

Sincerely yours.

iriam C. Provost, Ph.D. 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):

Device Name: ArComXL™ Acetabular Liners and Biolox® delta Ceramic Heads

## Indications For Use:

- 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.
- 5) Revision of previously failed total hip arthroplasty.

Intended for cemented and uncemented applications

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)

Styp Rhodes

Sign-Off (Division Division of General, Restorative, and Neurologica! Devices

510(k) Number: K051411