RESPONSE 2000 CEMENTED HIP STEM

K000432 · DePuy Orthopaedics, Inc. · LZO · Apr 24, 2000 · Orthopedic

Device Facts

• Record ID: K000432
• Device Name: RESPONSE 2000 CEMENTED HIP STEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Apr 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• 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 is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Femoral stem and acetabular cup total hip components labeled "For cemented use only" are indicated only for use with bone cement.

Device Story

Response 2000 Cemented Hip Stem is a femoral hip prosthesis designed for cemented total hip arthroplasty. It replaces the femoral portion of the hip joint to restore mobility and reduce pain. The device features a smooth-stemmed design, specific distal tip geometry, and a taper neck. It is implanted by orthopedic surgeons in a clinical/hospital setting. The device provides structural support for the hip joint, relying on bone cement for fixation. It benefits patients by addressing joint damage from arthritis, necrosis, fractures, or previous surgical failure.

Clinical Evidence

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

Technological Characteristics

Femoral hip prosthesis; smooth-stemmed design; metal/polymer construction; taper neck; distal tip geometry; intended for cemented fixation.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (reconstruction, arthrodesis, hemiarthroplasty, surface replacement, or total hip replacement), or ankylosis, provided there is sufficient sound bone to seat and support components. For use with bone cement only.

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

• Paramount Cemented Hip Stem

Submission Summary (Full Text)

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K00432

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| MANUFACTURER: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Arlene C. Saull, RAC<br>Sr. Submissions Associate<br>DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581-0988 |
| TRADE NAME: | Response 2000 Cemented Hip Stem |
| COMMON NAME: | Femoral Hip Prosthesis |
| CLASSIFICATION: | Class II, per 21 CFR, 888.3350: Hip joint<br>metal/polymer semi-constrained cemented<br>prosthesis. |
| DEVICE PRODUCT CODE: | 87 JDI Prosthesis, Hip, Semi-Constrained,<br>Metal/Polymer, Cemented. |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | Paramount Cemented Hip Stem |

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## INTENDED USE AND DEVICE DESCRIPTION:

The subject Response 2000 Cemented Hip Stem is intended for cemented use to replace the femoral portion of the hip joint. The subject device is a smooth-stemmed prosthesis which is very similar to the Paramount Hip Stem design, which has been previously cleared by FDA for cemented use.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The subject device is similar to the predicate device in that it uses the same material, has the same stem lengths, same intended use, same indications, same distal tip geometry and uses the same taper neck design.

7S&ESummary

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Public Health Service

# APR 2 4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Arlene C. Saull, RAC Senior Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K000432

Trade Name: Response 2000 Cemented Hip Stem Regulatory Class: II Product Code : LZO and JDI Dated: February 8, 2000 Received: February 9, 2000

Dear Ms. Saull:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Arlene C. Saull, RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Donna R. Vochner.

Celia M. Witten, Ph.D., M.D. (1) Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo consists of a black circle to the left of the word "DePuy" in a bold, sans-serif font. Below "DePuy" is a horizontal line, and below that is the text "a Johnson+Johnson company" in a smaller, script-like font. The logo is simple and professional, reflecting the company's association with healthcare and medical devices.

### INDICATIONS

### 000432 510(k) Number (if known)

Device Name: Response 2000 Cemented Hip Stem

### Indications:

(The package insert includes intended use/indications for several types of femoral components. The below text, which is extrapolated from the package insert (see Exhibit D), contains only the intended use/indications pertinent to the Response 2000 Cemented Hip Stem.)

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, theumatoid arthritis, or 1. congenital hip dysplasia.
- 2. Avascular necrosis of the femoral head.
- 3. Acute traumatic fracture of the femoral head or neck.

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- Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, 4. surface replacement arthroplasty, or total hip replacement.
- న్ Certain cases of ankylosis.

#### Cemented Components:

Femoral stem and acetabular cup total hip components labeled "For cemented use only" are indicated only for use with bone cement.

Concurrence of CDRH, Office of Device Evaluation:

OR

Donna R. Lochner.

(Division Sign-Off)
Division of General Restorative De 510(k) Number

Prescription Use X

Over-The Counter Use (Per 21 CFR 801.109)

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