CLS SPOTORNO STEM

K042249 · Zimmer Austin, Inc. · LZO · Sep 15, 2004 · Orthopedic

Device Facts

• Record ID: K042249
• Device Name: CLS SPOTORNO STEM
• Applicant: Zimmer Austin, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Sep 15, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CLS™ Spotorno™ Femoral Stem is intended for use as a prosthetic replacement of the proximal portion of the femur during total hip arthroplasty. It is indicated for cementless use in total hip replacement in treatment of the following: patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis and conditions of inflammatory degenerative joint disease (IJD), e.g. rheumatoid arthritis; those patients with failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed hip arthroplasty.

Device Story

CLS™ Spotorno™ Femoral Stem is a prosthetic implant for proximal femur replacement during total hip arthroplasty. Device functions as a mechanical structural support for hip joint reconstruction. Used in clinical settings by orthopedic surgeons. Modified version includes 125° stem with increased offset, slim neck, and short taper; design below resection line remains identical to predicate. Implant provides stability and restores joint function in patients with degenerative joint disease or failed prior arthroplasty. Benefit is improved mobility and pain reduction.

Clinical Evidence

Bench testing only. Fatigue testing performed on the modified CLS 125° stem design to verify structural integrity under physiological loading; all samples met acceptance criteria.

Technological Characteristics

Femoral stem prosthesis for cementless total hip arthroplasty. Features include 125° stem angle, increased offset, slim neck, and short taper. Materials and manufacturing processes are consistent with previously cleared CLS™ Stems.

Indications for Use

Indicated for patients requiring cementless total hip replacement due to noninflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis), inflammatory degenerative joint disease (e.g., rheumatoid arthritis), failed previous surgery with persistent pain/deformity/dysfunction, or revision of failed 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

• CLS™ Stems

Submission Summary (Full Text)

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## SEP 1 5 2004 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

- Zimmer Austin, Inc. Submitter: 9900 Spectrum Drive Austin, TX 78717 [phone]
- Zimmer GmbH Manufacturer: Sulzer Allee 8 Winterthur, 8404 Switzerland
- August 16, 2004 Date:
- Contact Person: Audrey Swearingen Manager, Regulatory Affairs
- Hip joint metal/ceramic/polymer semi-constrained cemented or Classification Name: nonporous uncemented prosthesis 21CFR 888.3353
- Common/Usual Name: Femoral Stem
- CLS™ Spotorno™ Stem Trade/Proprietary:

## Product Description:

The CLS™ Spotorno™ Femoral Stem is intended for use as a prosthetic replacement of the proximal portion of the femur during total hip arthroplasty. It is indicated for cementless use in total hip replacement in treatment of the following:

- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. + avascular necrosis, osteoarthritis and conditions of inflammatory degenerative joint disease (IJD), e.g. rheumatoid arthritis;
- those patients with failed previous surgery where pain, deformity, or dysfunction � persists;
- revision of previously failed hip arthroplasty �

This Special 510(k) incorporates the following changes as compared to the original device configuration: 1) addition of the CLS 125° stem, with an increased offset; and 2) incorporation of a slim neck and short taper. Below the resection line, the design of the modified stem remains the same as the legally marketed device.

## Substantial Equivalence:

The modified CLS™ Spotorno™ Stem is substantially equivalent in terms of fundamental design, materials, manufacturing, indications for use and intended use to the previously cleared, currently marketed CLS™ Stems.

Verification activities included fatigue testing of the CLS 125° to ensure that the modified design is safe and effective. All test samples met the acceptance criteria, thus indicating that the device, as modified, will survive physiological loading.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2004

Ms. Audrey Swearingen Manager, Regulatory Affairs Zimmer Austin, Inc. 9900 Spectrum Drive Austin, TX 78717

K042249 Re: Trade/Device Name: CLSTM Spotorno™ Femoral Stem Regulatory 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: August 18, 2004 Received: August 19, 2004

Dear Ms. Swearingen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rollowed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use bated in the eners of 776, 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, do noo that hat to other hat 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 I 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 or any 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 the rate 877, accems (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. Audrey Swearingen

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and w yourse 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 11 you desire spocific acries in 101 [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 other golderal informational 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,

Miriam C. Provost

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): __ ҚоЧ2249

Device Name: CLS™ Spotorno™ Stem

Indications for Use:

The CLS™ Spotorno™ Femoral Stem is intended for cementless use in total hip replacement in treatment of the following:

- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular � pations osteoarthritis and conditions of inflammatory degenerative joint disease (IJD), e.q. rheumatoid arthritis;
- e.g. Treathator artimal �
- revision of previously failed hip arthroplasty. �

Prescription Use
(Part 21 CFR 801 Subpart D) X

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** K042249

(Posted November 13, 2003)