PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS

K031495 · DePuy Orthopaedics, Inc. · LPH · Jun 11, 2003 · Orthopedic

Device Facts

• Record ID: K031495
• Device Name: PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jun 11, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.

Device Story

Pinnacle Duofix HA Acetabular Cup Prosthesis is a hemispherical, porous-coated (Porocoat) titanium alloy (Ti-6Al-4V) shell with hydroxyapatite (HA) coating. Designed for cementless implantation in total hip replacement or revision procedures. Interior features groove and taper to lock in UHMWPE or metal liners; articulates with femoral head. Includes apical threaded hole for insertion instrument; optional titanium alloy plug prevents particulate migration and supports polyethylene. Available in 48mm-66mm diameters in 'No Hole' or 'Cluster Hole' configurations. Used by orthopedic surgeons in clinical/OR settings. Provides stable acetabular component for hip joint reconstruction; restores joint function; reduces pain.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and technological similarities to predicate devices.

Technological Characteristics

Titanium alloy (Ti-6Al-4V) hemispherical shell; Porocoat porous coating; hydroxyapatite (HA) coating. Cementless fixation. Sizes 48mm-66mm. Configurations: No Hole or Cluster Hole. Apical threaded hole with optional titanium alloy plug. Mechanical locking mechanism for liners.

Indications for Use

Indicated for total hip replacement in patients with severe hip pain/disability due to rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, nonunion of femoral fractures, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, or previous fusion with inadequate bone stock. Indicated for revision arthroplasty. For cementless application.

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 (K000306)
• DePuy TriFlange Acetabular Cup (K001277)

Submission Summary (Full Text)

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**JUN 11 2003**

K031495- 1

### 510(k) Summary

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Est. Reg. No. 1818910 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Karla A. Ham<br>Senior Regulatory Associate<br>Phone: [phone]<br>FAX: [phone] |
| TRADE NAME: | Pinnacle Duofix™ HA Acetabular<br>Cup Prosthesis |
| COMMON NAME: | Acetabular Cup Prosthesis |
| CLASSIFICATION: | Class II Device per 21 CFR 888.3358:<br>Hip joint metal/polymer/metal semi-constrained<br>porous coated uncemented prosthesis |
| DEVICE PRODUCT CODE: | 87LPH |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | Acetabular Cup: DePuy Pinnacle Acetabular<br>System, K000306<br>HA Porous Coating: DePuy TriFlange Acetabular<br>Cup K001277 |

#### DEVICE DESCRIPTION:

The Pinnacle Duofix HA Acetabular Cup Prosthesis is a sintered, porous-coated (Porocoat®) hemispherical outer acetabular shell manufactured from titanium alloy (Ti-6Al-4V) with a thin layer of hydroxyapatite (HA) coating applied.

The interior of the acetabular cup is designed with a groove and a taper for use with either an ultra-high molecular weight polyethylene (UHMWPE) or metal acetabular cup liner, which lock into the shell. Articulation occurs between the liner, and a femoral head with the appropriately sized diameter.

The shells contain an apical threaded hole to allow the surgeon to attach the shell insertion instrument and grasp the shell during implantation. An optional titanium alloy (Ti-6Al-4V) apical hole plug is available to screw into the threaded apical hole of the shell. The plug is intended to occlude the apical hole in order to prevent particulate migration and provide polyethylene support.

The Pinnacle Duofix HA Acetabular Cup Prosthesis is provided in shell diameter sizes 48mm through 66mm in both the "No Hole" (100 series) and the "Cluster Hole" (Sector series) configurations.

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# 510(k) Summary (cont.)

#### INTENDED USE AND INDICATIONS:

The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.

### BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on similarities of design, materials, sterilization processes, and the same intended use, DePuy believes that the Pinnacle Duofix HA Acetabular Cup is substantially equivalent to the previously cleared Pinnacle Acetabular System, K000306.

In addition, DePuy believes that the hydroxyapatite (HA) coating applied to the Pinnacle Duofix HA Acetabular Cup Prosthesis is substantially equivalent to the HA coating applied to the DePuy TriFlange Acetabular Cup, cleared in K001277.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three birds in flight, arranged in a row.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2003

Ms. Karla A. Ham Senior Regulatory Associate Depuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K031495

Trade/Device Name: Depuy Pinnacle Duofix™ HA Acetabular Cup Prosthesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained, porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: April 25, 2003 Received: May 14, 2003

Dear Ms. Ham:

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 - Ms. Karla A. Ham

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 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 responsibilities under the Act may be obtained 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.

Miriam C. Provost

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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510(k) Number (if known): ূ长ο 3149/

#### Pinnacle Duofix™ HA Acetabular Cup Prosthesis Device Name:

### Indications for Use:

The Pinnacle Duofix™ HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use A

uriam C. Provost

Division of General. Restorative and Neurological Devic

OR

510(k) Number K031495

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