ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM

K030373 · Centerpulse Orthopedics, Inc. · LZO · Mar 6, 2003 · Orthopedic

Device Facts

• Record ID: K030373
• Device Name: ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
• Applicant: Centerpulse Orthopedics, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Mar 6, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is intended to be used with Centerpulse Orthopedics acetabular components and metallic or ceramic femoral heads possessing a 12/14 taper.

Device Story

The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is a conical, straight, rectangular-cross-section femoral hip prosthesis designed for non-cemented implantation. It serves as a replacement for femoral anatomy during total hip arthroplasty. The SLL variant features a distal length up to 20% greater than the SL variant to provide primary stability in cases of poor bone quality. The device is implanted by a surgeon; it anchors via distal edges and proximal cortical contact. The design includes a slim neck and short taper to increase range of motion by up to 12°, reducing impingement and dislocation risk. The stem is manufactured from wrought Ti-Al-Nb titanium alloy with a grit-blasted surface to enhance the bone/prosthesis interface. It is intended for use with compatible acetabular components and femoral heads.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and technological similarities to the predicate device.

Technological Characteristics

Material: Wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM F1295-92). Design: Conical straight stem, rectangular cross-section, slim neck, short taper. Surface: Grit-blasted. Fixation: Non-cemented (uncemented).

Indications for Use

Indicated for patients requiring total hip replacement due to noninflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis), inflammatory 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

• Zweymueller™ SL Femoral Stem (K962101)

Submission Summary (Full Text)

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## 510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Centerpulse Orthopedics Ltd. Alloclassic™ Zweymueller™ SL/SLL Femoral Stem.

| Manufacturer: | Centerpulse Orthopedics Ltd.<br>Altgasse 44<br>CH-6340 Baar, Switzerland | MAR 0 6 2003 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------|
| US Distributor: | Centerpulse Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, Texas 78717<br>[phone] | |
| Date: | January 31, 2003 | |
| Contact Person: | Audrey Swearingen, RAC<br>Manager, Regulatory Affairs<br>[phone] | |
| Classification Name: | 21 CFR Part 888.3353 - Hip joint metal/ceramic/polymer semi-<br>constrained cemented or nonporous uncemented prosthesis | |
| Common/Usual Name: | Femoral Hip Stem | |
| Trade/Proprietary Name: | Alloclassic™ Zweymueller™ SL/SLL Femoral Stem | |

## PRODUCT DESCRIPTION

The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is designed as a conical straight stem with a rectangular cross section to ensure rotational stability. Distally the SLL stem is up to 20% longer than the same size SL stem, while maintaining the same conical features. This provides the surgeon with greater freedom of choice even in primary operations. A SLL stem of the same size as the pre-selected SL stem can be implanted to achieve primary stability in cases of unexpected poor bone quality. Distally the stem is anchored primarily by its edges; proximally the surfaces anchor against the bone cortex.

The general design of the Alloclassic™ Zweymueller™ SL/SLL Femoral Stem with the slim neck and short taper remains unchanged as compared to the design of the previously cleared Zweymueller™ SL Femoral Stem.

The modified design increases the patient's range of motion by up to 12° following a total hip replacement. The risk of impingement and ultimately the risk of dislocation are reduced following a total hip replacement.

The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM F1295-92). The entire stem below the neck of the hip stem is grit blasted to provide enhanced bone/prosthesis interface.

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## SPECIFIC DIAGNOSTIC INDICATIONS

There have been no changes in the diagnostic indications for use of the previously cleared device as a result of this modification.

The Alloclassic™ Zweymueller® SL/SLL Femoral Stem is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is intended to be used with Centerpulse Orthopedics acetabular components and metallic or ceramic femoral heads possessing a 12/14 taper.

The indications for use of the Alloclassic™ Zweymueller® SL/SLL Femoral Stem are for treatment of the following:

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

## SUBSTANTIAL EQUIVALENCE

Therefore, based on the information provided, Centerpulse Orthopedics believes the Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is substantially equivalent to the previously cleared, Zweymueller™ SL Femoral Stem (ref. K962101 as Exhibit 9) as it has the same indications for use, basic design, sizes, material, sterilization method of manufacture.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle. The seal is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 6 2003

Ms. Audrey Swearingen, RAC Manager, Regulatory Affairs Centerpulse Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K030373

Trade/Device Name: Alloclassic" Zwevmueller" SL/SLL Femoral Stem Regulation Numbers: 21 CFR 888.3353 Regulation Names: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO. JDI. KWY. KWL Dated: January 31, 2003

Received: February 4, 2003

Dear Ms. Swearingen:

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. Iisting 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 Page 2 - Ms. Audrey Swearingen, RAC

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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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

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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# K030373

510(k) Number (if known):

Device Name: Alloclassic™ Zweymueller TM SL/SLL Femoral Stem

## Indications for Use:

The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is intended for prosthetic replacement without bone cement in treatment of the following:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use** *_*_

OR

Over-The-Counter Use

Mark N Millam
Division Sign-Off

(Optional Format 1-2-96)

Division of General, Restorative
and Neurological Services

510(k) Number K030373