MS-30 FEMORAL STEM STANDARD AND LATERAL

K040803 · Zimmer, Inc. · LZO · Apr 29, 2004 · Orthopedic

Device Facts

• Record ID: K040803
• Device Name: MS-30 FEMORAL STEM STANDARD AND LATERAL
• Applicant: Zimmer, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Apr 29, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MS-30 Femoral Stem is intended for cemented use in treatment of the following: - Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases. - Fractures or vascular necroses. - Status following earlier operations, such as joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty of total hip prosthesis (THP).

Device Story

MS-30 Femoral Stem is a highly polished, collarless femoral component for hip arthroplasty; manufactured from forged stainless steel alloy; available in six standard and six lateral sizes; lateral version provides 12% increased offset. Device is intended for cemented use by orthopedic surgeons in clinical settings. It replaces the femoral head/neck to restore joint function in patients with degenerative, traumatic, or necrotic hip conditions. Clinical benefit includes pain relief and restoration of joint mobility.

Clinical Evidence

No clinical data; substantial equivalence supported by bench testing, design comparisons, and functional analyses.

Technological Characteristics

Material: Forged stainless steel alloy. Design: Highly polished, collarless femoral stem. Configuration: Available in standard and lateral (12% offset) versions. Intended for cemented fixation. No software or electronic components.

Indications for Use

Indicated for patients requiring cemented hip arthroplasty due to degenerative, posttraumatic, or rheumatic joint wear; fractures; vascular necroses; or revision of prior procedures including osteotomy, arthrodesis, or hemiarthroplasty.

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

• MS-30 Femoral Stem standard (K993043, K001078)
• MS-30 Femoral Stem lateral (K020713)

Submission Summary (Full Text)

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K040803

(fg lot)

#### 510(k) SUMMARY APR 2 9 2004

| SPONSOR NAME: | Centerpulse Orthopedics, Inc.<br>9900 Spectrum Drive<br>Austin, TX 78717 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Robert M. Wolfarth<br>Phone: [phone]<br>E-Mail: [e-mail] |
| TRADE NAME: | MS-30 Femoral Stem, Standard and Lateral |
| COMMON NAME: | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis |
| CLASSIFICATION: | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prostheses (Product Code 87 LZO) are Class<br>II per 21 CFR §888.3353, reviewed by the Orthopedic Devices pane |

#### PREDICATE DEVICES:

MS-30 Femoral Stem standard: K993043, K001078 MS-30 Femoral Stem lateral: K020713

### DEVICE DESCRIPTION:

The MS-30 Stem is a highly polished, collarless femoral component manufactured from forged stainless steel alloy. It is available in six standard sizes and six lateral sizes. The lateral version offers the surgeon a 12% offsct versus the standard version. The MS-30 Stem is intended for cemented use.

#### INTENDED USE:

The MS-30 Fernoral Stem is intended for cemented use in treatment of the following:

- Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases. .
- . Fractures or vascular necroses.
- Status following earlier operations, such as joint reconstruction (osteotomy), arthrodesis, . hemiarthroplasty of total hip prosthesis (THP).

## BASIS OF SUBSTANTIAL EQUIVALENCE:

Performance tests, design comparisons, and functional analyses conducted on the MS-30 Femoral Stem demonstrate that it is substantially equivalent to the predicate devices.

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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 stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

APR 2 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert M. Wolfarth Regulatory Affairs Programs Manager Zimmer. Inc. 9900 Spectrum Drive Austin, Texas 78717

Rc: K040803 Trade/Device Name: MS-30 Femoral Stem Standard and Lateral Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prostheses Regulatory Class: II Product Code: LZO Dated: March 26, 2004 Received: March 30, 2004

Dear Mr. Wolfarth:

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 cquivalence 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 (OS) 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- Mr. Robert M. Wolfarth

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/dsma/dsmamain.html

Sincerely yours,

sincerely yours,

Mark A. Millman

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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# Indications for Use

510(k) Number (if known):

Device Name: MS-30 Femoral Stem Standard and Lateral

Indications For Use:

The MS-30 Femoral Stem is intended for cemented use in treatment of the following:

- Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases. t
- Fractures or vascular necroses. .
- Status following earlier operations, such as joint reconstruction (osteotomy), arthrodesis, � hemiarthroplasty of total hip prosthesis (THP).

Prescription Use × (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)

Mark A. Mikkelsen

Page 1 of Division of General, Restorative. and Neurological Devices

510(k) Number K040803