DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062

K040544 · Depuy, Inc. · LPH · May 28, 2004 · Orthopedic

Device Facts

• Record ID: K040544
• Device Name: DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062
• Applicant: Depuy, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: May 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Duraloc® Option Acetabular Cup System is for total hip replacement. A 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. 5. Certain cases of ankylosis. The acetabular cups are indicated for cementless application.

Device Story

Duraloc® Option Acetabular Cup System is a hip prosthesis for total hip arthroplasty. Device comprises UHMWPE acetabular liner and porous-coated Ti-6Al-4V acetabular shell; secured via Co-Cr-W-Ni alloy locking ring. Liner interlock allows rotation to match patient anatomy. System articulates with 28mm or 22.225mm femoral heads. Used by orthopedic surgeons in clinical settings to replace damaged hip joint articulation; aims to increase patient mobility and reduce pain. Cementless application.

Clinical Evidence

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

Technological Characteristics

Materials: UHMWPE (liner), Ti-6Al-4V (shell), Co-Cr-W-Ni alloy (locking ring). Form factor: Acetabular cups 46-66mm (2mm increments). Principle: Cementless, semi-constrained hip prosthesis. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to severe pain/disability from 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/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• DePuy Pinnacle Acetabular System (K001534)
• DePuy Duraloc Cementless Acetabular Cup System (K961186)

Reference Devices

• Femoral heads (K920317)
• Femoral heads (K980513)
• Femoral heads (K893872)
• Femoral heads (K883460)
• Femoral heads (K860701)
• Femoral heads (K891082)
• Femoral heads (K011533)

Submission Summary (Full Text)

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K040544

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF SPONSOR: | DePuy® Inc.<br>P.O. Box 988<br>Warsaw, IN 46581-0988<br>Registration Number: 1818910 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Dina L. Weissman, J.D.<br>Legal Consultant, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| TRADE NAME:<br>COMMON NAME: | Duraloc® Option Acetabular Cup System<br>Hip Prosthesis |
| REGULATORY CLASSIFICATION: | 888.3358 Hip joint metal/polymer/metal semi-<br>constrained porous-coated uncemented prosthesis<br>888.3353 Prosthesis, hip, semi-constrained,<br>metal/ceramic/polymer, cemented or non-porous,<br>uncemented, CLASS II |

#### DEVICE PRODUCT CODE: 87 LPH and 87 LZO

### SUBSTANTIALLY EQUIVALENT DEVICES:

- DePuy Pinnacle Acetabular System (K001534) .
- DePuy Duraloc Cementless Acetabular Cup System (K961186) .

#### DEVICE DESCRIPTION AND INTENDED USE:

The Duraloc® Option Acctabular Cup System consists of a UHMWPE acetabular cup liner secured to a porous-coated Ti-6A1-4V acetabular shell. The acetabular system articulates with previously cleared 28mm fernoral heads, as well as with 22.225mm femoral heads internally documented by DePuy as line extensions to femoral heads cleared in K920317 and K980513.

The 28mm femoral heads were cleared in K920317 on March 19, 1992, K893872 on July 11, 1989, K883460 on October 11, 1998, K860701 on March 19, 1986, K891082 on June 9, 1989 and K011533 on January 28, 2002.

The acetabular cups are sized from 46mm to 66mm, in 2 mm increments. The liners are available in two styles: neutral and lipped. Liners with a 22,225mm inner diameter are offered in the outer diameter of 46mm. Liners with a 28mm inner diameter are offered in outer diameters of 48/50mm, 52mm, 54/56mm, 58/60mm, and 62/64/66mm.

The liner interlock allows the liner to be rotated to match the patient's anatomy. A locking ring, manufactured from Co-Cr-W-Ni alloy, is used to secure the liner.

The cups and liners are intended to be used in total hip arthroplasty to provide increased patient mobility and to reduce pain by replacing damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components.

The acetabular cups are indicated for cementless application.

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Image /page/1/Picture/1 description: The image shows a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human services.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 8 2004

Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs DePuy, Inc. P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K040544

Trade/Device Name: Duraloc® Option Acetabular Cup System Regulation Number: 21 CFR 888.3358 and 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis and Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Regulatory Class: II

Product Codc: LPH and LZO Dated: March 1, 2004 Received: March 2, 2004

Dear Dr. Weissman:

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

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Page 2 - Dina L. Weissman, J.D.

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 premated 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 responsibilities 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/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

Mark A. Milliman

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 for Use

510(k) Number (if known): K040544 Device Name: Duraloc® Option Acetabular Cup System Indications for Use:

The Duraloc® Option Acetabular Cup System is for total hip replacement.

A 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.
- 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, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.

The acetabular cups are indicated for cementless application.

Prescription Use XXXX Over-The-Counter Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Millkeum

Division of General, Restorative and Neurological Devices

K040544
mber

510(k) Number.