DEPUY SUMMIT BASIC PRESS-FIT HIP STEM

K030122 · DePuy Orthopaedics, Inc. · LWJ · Feb 5, 2003 · Orthopedic

Device Facts

• Record ID: K030122
• Device Name: DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LWJ · Orthopedic
• Decision Date: Feb 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: - A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia; - Avascular necrosis of the femoral head; - Acute traumatic fracture of the femoral head or neck; - Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement; - Certain cases of ankylosis.

Device Story

Summit Basic Press-Fit Hip Stem is a collared, tapered Titanium femoral stem with grit-blasted finish; designed for cementless, press-fit fixation in total hip arthroplasty. Device replaces damaged hip joint articulation to reduce pain and improve mobility. Offered in 7 sizes with constant neck offset. Used by orthopedic surgeons in clinical/surgical settings. Provides structural support for hip joint reconstruction. Benefits patients by restoring joint function and alleviating pain associated with degenerative or traumatic hip conditions.

Technological Characteristics

Collared, tapered femoral stem; material: Ti-4V-6Al alloy; surface finish: grit blasted; fixation: cementless, press-fit; configuration: 7 sizes with constant neck offset.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to osteoarthritis, traumatic/rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head/neck, failed previous hip surgery, or ankylosis, provided sufficient sound bone exists to support components.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• DePuy Response 2000 Hip Stems (K000392)

Submission Summary (Full Text)

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K030/22

page 171

2003

## SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Orthopaedics, Inc.<br>P.O. Box 988<br>700 Orthopaedic Drive<br>Warsaw, IN 46581-0988 | FEB 05 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------|
| 510(k) CONTACT: | Cheryl Hastings<br>Director, Regulatory Affairs | |
| TRADE NAME: | DePuy Summit Basic Press-Fit Hip Prosthesis | |
| COMMON NAME: | Total Hip Joint Replacement Prosthesis | |
| CLASSIFICATION: | 888.3353: Hip joint metal/ceramic/polymer semi-<br>constrained cemented or non-porous uncemented<br>prosthesis; Class II | |
| DEVICE PRODUCT CODE: | 87 LZO | |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE: | DePuy Response 2000 Hip Stems, K000392 | |

### DEVICE DESCRIPTION:

The Summit Basic Press-Fit Hip Stem is a collared, tapered Titanium femoral stem with a grit blasted finish. The Summit Basic Press-Fit Hip Stem is offered in 7 sizes with a constant neck offset. The stem is intended for cementless, press-fit fixation and is designed specifically to treat femoral head and neck fractures but can be used for any of the indications listed below.

### INTENDED USE AND INDICATIONS:

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia;
- A vascular necrosis of the femoral head; ●
- Acute traumatic fracture of the femoral head or neck; ●
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, . hemiarthroplasty, surface replacement arthroplasty, or total hip replacement;
- . Certain cases of ankylosis.

### BASIS OF SUBSTANTIAL EQUIVALENCE:

The Summit Basic Press-Fit Hip Stem has the same basic design and has the same intended use as the Response 2000 Hip Stem. The Summit Basic Press-Fit Stem is manufactured from Ti-4V-6Al alloy while the Response 2000 Hip Stem is manufactured from Co-Cr-Mo alloy. The designs are similar - both stems are available in a single offset, but the Summit Basic Press-Fit Hip Stem is officred in only one stature while the Response 2000 Hip Stem is offered in large and small statures.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2003

Ms. Cheryl Hastings Director, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K030122

Trade/Device Name: DePuy Summit Basic Press-Fit Hip Prosthesis Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-constrained Cemented Prosthesis Regulatory Class: Class II Product Code: LWJ Dated: January 13, 2003 Received: January 14, 2003

Dear Ms. Hastings:

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

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Page 2 -- Ms. Cheryl Hastings

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. 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). 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.

Mark N. Milken

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

Enclosure

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510(k) Number (if known) _ Kos of レレレ

Device Name DePuy Summit Basic Press-Fit Hip Stem

Intended Use and Indications:

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Total hip replacement is indicated in the following conditions:

- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid . arthritis, or congenital hip dysplasia;
- Avascular necrosis of the femoral head; .
- Acute traumatic fracture of the femoral head or neck; .
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, . hemiarthroplasty, surface replacement arthroplasty, or total hip replacement;
- Certain cases of ankylosis. .

Concurrence of CDRH, Office of Device Evaluation

*for*

| (Division Sign-Off) | |
|--------------------------|------------------------|
| Division of | Geriatric, Restorative |
| and Neurological Devices | |
| 510(k) Number | K030122 |

Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The Counter Use\$\mathcal{B}\$

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