ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS

K062997 · Biomet Manufacturing Corp · LZO · Dec 8, 2006 · Orthopedic

Device Facts

• Record ID: K062997
• Device Name: ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
• Applicant: Biomet Manufacturing Corp
• Product Code: LZO · Orthopedic
• Decision Date: Dec 8, 2006
• Decision: SESE
• Submission Type: Traditional
• 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 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. Cemented and Uncemented Applications

Device Story

ArComXL™ Polyethylene Liners and 38/40mm Femoral Heads are orthopedic components for total hip arthroplasty. Liners are manufactured from highly cross-linked ultra-high molecular weight polyethylene (UHMWPE); femoral heads are one-piece CoCrMo designs with neck length variations (-6mm to +9mm). Device functions as a bearing surface within a hip prosthesis system. Used by orthopedic surgeons in clinical settings for joint replacement or revision surgery. Provides stable articulation to restore joint function and mobility; reduces pain associated with degenerative joint disease or fractures. No software or electronic components.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical verification activities demonstrating that the device meets or exceeds current standards and guidelines.

Technological Characteristics

Materials: UHMWPE per ASTM F-648; CoCrMo alloy. Components: Acetabular liners and 38/40mm femoral heads. Design: One-piece femoral head with neck length variations (-6mm to +9mm). Application: Cemented or uncemented hip arthroplasty. No software or electronic components.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or proximal femur fractures (non-union, femoral neck, trochanteric) requiring hip arthroplasty, including revision of failed total hip arthroplasty. Suitable for cemented and uncemented applications.

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)
• ArCom® Acetabular Liners (K023357)
• 36mm MaxRom™ Acetabular Liners (K032396)
• M2a™ Acetabular System (K011110)
• M2a Magnum™ System (K042037)

Submission Summary (Full Text)

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K062997 1/2

BIOMET

ORTHOPEDICS, INC.

## 510(k) Summar

| Preparation Date: | September 28, 2006 | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Applicant/Sponsor: | Biomet Manufacturing Corp.<br>56 East Bell Drive<br>P.O. Box 587<br>Warsaw, IN 46581-0587 | DEC 08 2006 |
| Contact Person: | Becky Earl | |
| Proprietary Name: | ArComXL™ Polyethylene Liners and 38/40mm Femoral Heads | |
| Common Name: | UHMWPE; Femoral Heads | |
| Classification Name: | - hip joint metal/polymer/metal semi-constrained porous coated<br>uncemented prosthesis (888.3358)<br>- hip joint metal/polymer semi-constrained cemented prosthesis<br>(888.3350)<br>- hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis (888.3353) | |

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: ArComXL™ Acetabular Liners— K042051 (Biomet, Inc.), ArCom® Acetabular Liners—K023357 (Biomet, Inc.), 36mm MaxRom™ Acetabular Liners—K032396 (Biomet, Inc.), M2a™ Acetabular System—K011110 (Biomet, Inc.), and M2a Magnum™ System-K042037 (Biomet, Inc.)

Device Description: Biomet Manufacturing Corp. is adding additional sizes and designs to the predicate ArComXL™ Acetabular Liners (K042051). The same manufacturing process used in the predicate results in a higher cross-linked polyethylene that Biomet will herein refer to as ArComXL™ . The femoral heads, sizes 38mm and 40mm, are a one-piece design with neck length variations ranging from -6mm to +9mm made from CoCrMo.

### Intended 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.

Cemented and Uncemented Applications

Summary of Technologies: The intended use, indications, and design specifications of the acetabular liners remain similar or identical to their predicate component counterparts. The only exception is the addition of 32 and 36mm in two designs and 38 and 40mm size liners for all included designs. The raw material being utilized in the manufacture of the subject devices is an ultra-high

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

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 574.267.6639

FAX
574.257.8137

E-MAIL [e-mail]

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K062997 2/2

### 510(k) Summary - Page 2 of 2 STO(R) Summal y - Continuers and 38/40mm Femoral Heads (Continued)

molecular weight polyethylene (UHMWPE) per ASTM F-648, identical to the predicate (K042051). The morecallar welght polychylche (OHTTP: 2) per Rom P" (UHMWPE) Acetabular Liners were previously established in K042051.

The intended use, indications, contraindications, and design specifications of the femoral heads are The Interious use, Indications, contrainciedions, and acticulating surface which is changed from metal-onluentical to their predicates with the encopies in either cemented or uncemented applications.

Non-Clinical Testing: Verification activities were performed on ArComXL™ liners, which met or exceeded current standards or guidelines.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2006

Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K062997

Trade/Device Name: ArComXL™ Polyethylene Liners and 38/40mm Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: September 29, 2006 Received: October 02, 2006

Dear Ms. Earl:

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. Becky Earl

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 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,

Sincerely yours,

Barbara Buchner

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

Enclosure

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062997 ''//

# Indications for Use

510(k) Number (if known):

Device Name: ArComXL™ Polyethylene Liners and 38/40mm Femoral 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.

Cemented and Uncemented Applications

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

Over-The-Counter Use NO (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)

Barbara Buchholz

Restorative,

510(k) Number

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