SC TOTAL HIP SYSTEM

K031474 · Orthopedic Alliance, LLC · JDI · Oct 15, 2003 · Orthopedic

Device Facts

• Record ID: K031474
• Device Name: SC TOTAL HIP SYSTEM
• Applicant: Orthopedic Alliance, LLC
• Product Code: JDI · Orthopedic
• Decision Date: Oct 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SC Total Hip System is indicated for use in the treatment of severcly disabled hip joints resulting from painful osteo-, rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries. The SC Femoral Hip Stem is indicated for use with or without bonc cement. The SC Acetabular Cup is for use with bone cement only.

Device Story

SC Total Hip System replaces severely disabled hip joints; provides pain relief and improved function. System components include femoral stems (straight, non-porous, collarless, standard/lateralized/revision lengths), modular femoral heads, and UHMWPE acetabular components. Femoral stem used with or without bone cement; acetabular cup used with bone cement only. Device implanted by orthopedic surgeons in clinical/hospital settings. System restores joint mechanics, benefiting patients suffering from arthritis or trauma-induced disability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Ti6Al-7Nb Titanium alloy, CoCrMo alloy, and UHMWPE per ASTM and ISO standards. Design: Semi-constrained, metal/polymer, cemented prosthesis. Components: Femoral stems (straight, non-porous, collarless), modular femoral heads, and acetabular cups.

Indications for Use

Indicated for patients with severely disabled hip joints due to painful osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or late-stage avascular necrosis, and for revision of previous hip surgeries.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• SL-Plus Hip Stem
• Zweymuller SL Hip System
• Lester Press Fit Hip System
• Alloclassic Zweymuller SL Hip Stem

Submission Summary (Full Text)

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K031474

# OCT 1 5 2003

## Summary of Safety and Effectiveness for the SC Total Hip System

This safety and effectiveness summary for the SC Total Hip System is provided per Section 513(i)(3) of the Food, Drug and Cosmetic Act

l. Submitter : Orthopedic Alliance LLC 41558 Eastman Drive Suite A Marietta, CA 92562

Contact Person : Roger Williams Orthopedic Alliance LLC 41558 Eastman Drive Suite A Marietta, CA 92562 Telephone: ( 909 ) 304-9001

Date Prepared: May 3, 2003

2. Tradename: SC Total Hip System Common Name: Total Hip System Classification Name: Hip joint metal /polymer semi-constrained cemented prosthesis ( 888.3350 )

## 3. Predicate or legally marketed devices which are substantially equivalent :

- SL-Plus Hip Stem ( Plus Orthopedics )
- Zweymuller SL Hip System ( AlloPro ) ●
- Lester Press Fit Hip System ( Kirschner ) ●
- Alloclassic Zweymuller SL Hip Stem ( Sulzer Medica ) ●

#### 4. Description of the device :

The SC Total Hip System is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems, modular femoral heads and acetabular components. The femoral stems are straight, non-porous collarless designs in standard and lateralized configurations. Revision lengths are also available. The acctabular components are UHMWPE, in various diameters, with various offset options.

Materials: The devices are manufactured from Ti6Al-7Nb Titanium alloy, CoCrMo alloy and Ultra High Molecular Weight Polyethylene ( UHMWPE ) per ASTM and ISO standards.

Function: The system functions to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma.

#### 5. Intended Use:

The SC Total Hip System is indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and post-traumatic arthritis, and the late stages of avascular necrosis, and for the revision of previous hip surgeries.

The SC Femoral Hip Stern is indicated for use with or without bone cement. The SC Acctabular Cup is for use with bone cement only.

6. Comparison of the technological characteristics of the device to predicate and legally marketed devices :

There are no significant differences between the SC Total Hip System and other total hip systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, materials and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 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 edge. In the center of the seal are three stylized human profiles facing to the right, with flowing lines above them.

Public Health Service

OCT 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Roger Williams Orthopedic Alliance LLC 41558 Eastman Drive, Suite A Marietta, CA 92562

Re: K031474 Trade/Device Name: SC Total Hip System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI, LWJ Dated: September 17, 2003 Received: September 22, 2003

Dear Mr. Williams:

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 - Mr. Roger Williams

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,

Mark N. Millen

Celia 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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Page I of 1

510(k) Number ( if known ) : K031474

Device Name : SC Total Hip System

Indications For Use :

The SC Total Hip System is indicated for use in the treatment of severcly disabled hip joints resulting from painful osteo-, rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries.

The SC Femoral Hip Stem is indicated for use with or without bonc cement.

The SC Acetabular Cup is for use with bone cement only.

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

Concurrence of CDRH, Office of Device Evaluation ( ODE )

Prescription use ( PER 21 CFR 801.109)

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OR

Over-the-counter use _________________________________________________________________________________________________________________________________________________________

( optional format 1-2-96 )

Mark N. Milliman

vision Sign-Of Restorative and Neurologic

510(k) Number K031474 mna