MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD

K062748 · DePuy Orthopaedics, Inc. · LZO · Nov 30, 2006 · Orthopedic

Device Facts

• Record ID: K062748
• Device Name: MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Nov 30, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and to 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The DePuy Ceramic Femoral Head is intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head.

Device Story

Alumina composite ceramic femoral head; 36mm diameter; +9 and +12 offset options; 11/13 S-ROM internal bore taper. Device mates with DePuy femoral hip stems via mechanical taper junction; articulates with polyethylene acetabular component. Used in total hip arthroplasty to replace damaged femoral head articular surface. Implanted by orthopedic surgeons in clinical/hospital settings. Provides patient mobility and pain reduction by restoring hip joint function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Alumina composite material; 36mm diameter; 11/13 S-ROM taper; mechanical taper junction locking mechanism; intended for articulation with polyethylene acetabular components.

Indications for Use

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

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 Ceramic Femoral Heads (K031803)
• DePuy Ceramic Heads (K040644)

Submission Summary (Full Text)

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NOV 3 0 2006

510(k) 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 | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) CONTACT: | Anne M. Schuler<br>Sr. Regulatory Affairs Associate | |
| DATE PREPARED: | September 13, 2006 | |
| TRADE NAME: | DePuy Delta Ceramic Femoral Head | |
| COMMON NAME: | Ceramic Femoral Ball Prosthesis | |
| CLASSIFICATION: | 888.3353: Hip joint femoral metal/ceramic/polymer,<br>semi-constrained cemented or nonporous,<br>uncemented prosthesis; | |
| DEVICE PRODUCT CODE: | 87 LZO | |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE: | DePuy Ceramic Femoral Heads, K031803<br>DePuy Ceramic Heads, K040644 | |

#### DEVICE DESCRIPTION:

The DePuy Delta Ceramic Femoral Head is composed of an alumina composite material and is available in a 36mm head diameter with +9 and +12 offset options. The internal bore of the ceramic femoral head taper is available in an 11/13 S-ROM option.

The Delta Ceramic head is designed to mate with DePuy femoral hip stems with a corresponding taper design. The ceramic femoral head mechanically locks with the femoral hip stem via a taper junction, and articulates with a polyethylene acetabular component.

#### INDICATIONS FOR USE AND INTENDED USE:

#### Indications for Use

The DePuy Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and to 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.

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#### Intended Use

The DePuy Ceramic Femoral Head is intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The modified DePuy Delta Ceramic femoral heads have a similar design and the same intended use, indications, manufacturing method, sterilization and packaging as the Ceramic Femoral heads cleared in K031803 and in K040644. Based on this DePuy believes that the subject Delta Ceramic femoral heads are substantially equivalent to the previously cleared Ceramic femoral heads.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Anne M. Schuler Sr. Regulatory Affairs Associate P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

NUV 3 U 2006

Rc: K062748

Trade/Device Name: DePuy Delta Ceramic Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: September 13, 2006 Received: November 6, 2006

Dear Ms. Schuler:

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 east onc product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Anne M. Schuler

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 responsibilitics 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/industry/support/index.html.

Sincerely vours.

Barbara Buchum

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

Enclosure

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### Indications for Use

K062748 510(k) Number (if known): Device Name: DePuy Delta Ceramic Femoral Head

#### Indications for Use:

The DePuy Delta Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures.

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, 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.

| Prescription Use (Part 21 CFR 801 Subpart D) | XX |
|----------------------------------------------|----|
| Over-The-Counter Use (21 CFR 807 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurre ce of Device Evaluation (ODE)

*(Division Sign-Off)*

Hubare Buchem

Division of General, Restorative, and Neurological Devices

**510(k) Number** K062748