RESPONSE 2000 HIP STEM

K000392 · DePuy Orthopaedics, Inc. · LZO · Apr 24, 2000 · Orthopedic

Device Facts

• Record ID: K000392
• Device Name: RESPONSE 2000 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

The Response 2000 Hip Stern is intended for press-fit or cemented use in total bip arthroplasties.

Device Story

Response 2000 Hip Stem is a femoral hip prosthesis used in total hip arthroplasty. Device features straight-stem geometry, ASTM F-75 Co-Cr-Mo alloy construction, glass bead-blasted surface finish, and bullet-shaped distal tip. Designed for press-fit or cemented fixation; includes self-locking taper for connection to DePuy femoral head. Implanted by orthopedic surgeons in clinical/hospital settings to replace damaged hip joint articulation, aiming to restore patient mobility and reduce pain.

Clinical Evidence

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

Technological Characteristics

Material: ASTM F-75 Co-Cr-Mo alloy. Design: Straight-stem, glass bead-blasted surface finish, bullet-shaped distal tip. Fixation: Press-fit or cemented. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total hip arthroplasty for increased mobility and pain reduction 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 (joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement), or ankylosis, provided there is sufficient sound bone to seat and support components. Labeled for press-fit uncemented use or use with bone cement.

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

• DePuy Quantum Hip Stem
• DePuy Modular Press-Fit (MPF) Hip (Std. & MMA)
• DePuy Vision AML Hip Stems
• DePuy AML MMA Hip Stem

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581-0988 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Arlene C. Saull, RAC<br>Sr. Regulatory Associate<br>DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581-0988 |
| TRADE NAME: | ResponseTM 2000 Hip Stem |
| COMMON NAME: | Femoral Hip Prosthesis |
| CLASSIFICATION: | Class II, per 21 CFR, 888.3350 |
| DEVICE PRODUCT CODE: | 87 LZO Prosthesis, Hip, Semi-Constrained<br>Metal/Ceramic/Polymer, Cemented or Non-porou<br>Uncemented. |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | DePuy Quantum Hip Stem<br>DePuy Modular Press-Fit (MPF) Hip (Std. & MMA)<br>DePuy Vision AML Hip Stems<br>DePuy AML MMA Hip Stem |

#### DEVICE DESCRIPTION:

The Response 2000 Hip Stem is manufactured from ASTM F-75 Co-Cr-Mo alloy. It is a smooth, straight-stem design, which will have a glass bead-blasted surface finish, a bullet-shaped distal tip, and is designed with a self-locking taper for use with a DePuy femoral head.

### INDICATIONS AND INTENDED USE:

#### Intended Use:

The Response 2000 Hip Stern is intended for press-fit or cemented use in total bip arthroplasties.

# 000003

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#### 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:

- 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congcnital hip dysplasia.
- 2. Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck ని.
- Failed previous hip surgery including joint reconstruction, internal fixation, 4. arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.

# Non Porous-Coated Press-Fit or Cemented Components:

Non Porous-coated femoral hip stem prostheses labeled FOR PRESS-FIT OR CEMENTED USE are indicated for press-fit uncemented use, or for use with bone cernent.

# BASIS OF SUBSTANTIAL EQUIVALENCE:

The subject devices are identical to the predicate hip stem devices, in that they have the same straight stem geometry, materials and indications.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing hair or clothing. The logo is black and white.

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: K000392

Trade Name: Response 2000 Hip Stem Regulatory Class: II Product Code: LZO and JDI Dated: February 4, 2000 Received: February 7, 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 (OS) 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,

Dime R. Lochner.

Celia M. Witten, Ph.D., M.D. 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 solid black circle to the left of the name "DePuy" in a bold, sans-serif font. Below the name is a horizontal line, and beneath that, the text "a Johnson & Johnson company" is written in a smaller, cursive-like font.

#### INDICATIONS

#### 510(k) Premarket Notification

510(k) Number (if known) K000392

Response™ 2000 Hip System Device Name

Note: (The package insert includes intended uselindications for several types of femoral components. The below text, which is (11th plants of the package insert (see Exhibit D), contains only the intended uselindications perinent to the Response 2000 Hip Stem.)

#### Indications for 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, 1. rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head or neck. 3.
- Failed previous hip surgery including joint reconstruction, internal fixation, 4. arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. న.

# Non Porous-Coated Press-Fit or Cemented Components:

Non Porous-coated femoral hip stem prostheses labeled "FOR PRESS-FIT OR CEMENTED USE" are indicated for press-fit uncemented use, or for use with bone cement.

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Concurrence of CDRH, Office of Device Evaluation:

OR

Domer R. Lochner

Division of Coural 510(k) Number KOC C

7 Prescription Use

Over-The Counter Use (Per 21 CFR 801.109)

# 000004