EXCEL FRACTURE CEMENTED HIP STEM

K011367 · DePuy Orthopaedics, Inc. · JDI · Jun 15, 2001 · Orthopedic

Device Facts

• Record ID: K011367
• Device Name: EXCEL FRACTURE CEMENTED HIP STEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Jun 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• 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: 1) a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement; and 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

Excel Fracture Cemented Hip Stem is a modular, smooth-stemmed femoral prosthesis; constructed from cobalt chromium molybdenum alloy. Device replaces femoral portion of hip joint in total hip arthroplasty; intended for cemented use only. Used by orthopedic surgeons in clinical settings to restore mobility and reduce pain in patients with damaged hip joints. Device provides structural support for articulation; requires bone cement for fixation. Benefits include pain relief and improved joint function.

Clinical Evidence

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

Technological Characteristics

Cobalt chromium molybdenum alloy; modular, smooth-stemmed femoral prosthesis; cemented fixation; Class II device (21 CFR 888.3350).

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 (joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement), or ankylosis.

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

• Excel Fracture Cemented Hip Stem (cleared as Response 2000 Cemented Hip Stem) (K00432)

Submission Summary (Full Text)

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# 011367

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:

510(K) CONTACT:

TRADE NAME:

COMMON NAME:

CLASSIFICATION:

DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Sally Foust Sr. Regulatory Associate [phone] FAX [phone]

Excel Fracture Cemented Hip Stem

Hip Prosthesis

Class II device per 21 CFR, 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.

DEVICE PRODUCT CODE:

87 JDI

#### SUBSTANTIALLY EQUIVALENT DEVICE

Excel Fracture Cemented Hip Stem (cleared as Response 2000 Cemented Hip Stem) K00432

## DEVICE DESCRIPTION AND INTENDED USE:

The subject device is a cobalt chromium molybdenum alloy modular and smooth stemmed prosthesis that is intended for cemented use to replace the femoral portion of the hip joint in total hip arthroplasty. 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 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement; and 5) certain cases of ankylosis.

#### BASIS OF SUBSTANTIAL EQUIVALENCE:

Except for being a smaller size, the size 1 Excel Fracture Cemented Hip Stem is identical in design, material, manufacturing process and intended use to the Excel Fracture Cemented Hip Stem cleared as Response 2000 Cemented Hip Stem.

# 000003

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Image /page/1/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 tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. The text is written in a sans-serif font and is arranged in a circular pattern.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 2001

Ms. Sally Foust Senior Regulatory Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw. Indiana 46581

Re: K011367

Trade Name: Excel Fracture Cemented Hip Stem - Size 1 Regulation Number: 888.3350 Regulatory Class: II Product Code: JDI Dated: May 3, 2001 Received: May 4, 2001

Dear Ms. Foust:

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 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 (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. Sally Foust

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,

C. Colin M. Wittwer, Ph.D., M.D.

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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### INDICATIONS

510(k) Number (if known)

Device Name: Excel Fracture Cemented Hip Stem

#### INDICATIONS:

INDICATIONS.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by Total mp articulation in interiot articulation in patients where there is evidence of replacing the damaged seen 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 congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- 3. Acute traumatic fracture of the femoral head or neck.
- 5. Failed previous hip surgery including joint reconstruction, internal fixation, r anot provious mp broplasty, surface replacement arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.

#### Cemented Components:

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

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(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K011367

Over-The Counter Use

Prescription Use X 801.109)

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