DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS

K071784 · DePuy Orthopaedics, Inc. · LPH · Jul 25, 2007 · Orthopedic

Device Facts

• Record ID: K071784
• Device Name: DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jul 25, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• 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. Pinnacle Porous Coated Acetabular Cup total hip components are indicated for cementless use with fixation provided by biological tissue ingrowth into the porous coating.

Device Story

Modular acetabular component for total hip replacement; consists of hemispherical titanium alloy (Ti-6Al-4V) outer shell with proprietary Gription™ porous coating and UHMWPE or CrCoMo liner. Device implanted by orthopedic surgeons in clinical settings; fixation achieved via biological tissue ingrowth into porous coating (cementless). Liner articulates with femoral head to restore joint function, reduce pain, and improve patient mobility. Device replaces damaged hip joint articulation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical design, materials, and manufacturing processes to predicate devices.

Technological Characteristics

Acetabular cup system; hemispherical shell of titanium alloy (Ti-6Al-4V); liner of UHMWPE or high-carbon cobalt chrome (CrCoMo). Features proprietary Gription™ titanium porous coating for cementless biological fixation. Modular design; semi-constrained prosthesis.

Indications for Use

Indicated for total hip replacement in patients with severely painful/disabled joints due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head/neck, failed previous hip surgery (reconstruction, fixation, arthrodesis, hemiarthroplasty, surface replacement, or total hip replacement), or ankylosis. Indicated 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

• Pinnacle® Acetabular System (K001534)
• Pinnacle® Revision System (K033338)

Submission Summary (Full Text)

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JUL 2 5 2007

## 510 (k) Summary

(As required by 21 CFR 807.92 and 21 CFR 807.93)

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46582<br>Establishment Registration Number: 1818910 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rhonda Myer<br>Regulatory Affairs Associate<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| DATE PREPARED: | June 22, 2007 |
| PROPRIETARY NAME: | DePuy Pinnacle® with Gription™ Acetabular<br>Cups |
| COMMON NAME: | Acetabular Cup with Porous Coating |
| CLASSIFICATION: | Class II per 21 CFR 888.3358: Hip joint<br>metal/polymer/metal semi-constrained porous-<br>coated uncemented prosthesis |
| DEVICE PRODUCT CODE: | 87 LPH |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | Pinnacle® Acetabular System, K001534 (June 12, 2000)<br>Pinnacle® Revision System, K033338 (January 8, 2004) |

## DEVICE DESCRIPTION:

The Pinnacle Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (Ti-6Al-4V) and a liner manufactured from ultra high molecular weight polyetheylene (UHMWPE) or highcarbon cobalt chrome (CrCoMo), both of which lock into the outer shell. The liner component articulates with a femoral head of an appropriate diameter. The subject acetabular cups are coated with a new proprietary titanium porous coating, Gription" ".

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### INDICATIONS AND INTENDED USE:

#### Indications:

Pinnacle® Acetabular Cups are indicated for total hip replacement 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.

Porous-coated Pinnacle® Acetabular Cups are indicated for cementless application.

#### 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.

Pinnacle Porous Coated Acetabular Cup total hip components are indicated for cementless use with fixation provided by biological tissue ingrowth into the porous coating.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The Pinnacle® with Gription™ Acetabular Cups have the following similarities to the Pinnacle® Acetabular Cups (with Porocoat®) that were cleared in K001534 and K033338:

- . Identical intended use and indications for use
- Identical material �
- . Identical design
- Identical sterilization and packaging .
- . Identical method of manufacturing

The Pinnacle® with Gription™ Acetabular Cups are substantially equivalent to the Pinnacle® Acetabular Cups (with Porocoat®) based on similarities in intended use, indications for use, material, design, sterilization, packaging and method of manufacturing.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 5 2007

DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Affairs Associate 700 Orthopaedic Drive P.O. Box 988 Warsaw. Indiana 46581-0988

Re: K071784

Trade/Device Name: DePuy Pinnacle® with Gription™ Acetabular Cups Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: June 29, 2007 Received: July 2, 2007

Dear Ms. Myer:

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. Rhonda Myer

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehrle

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 Statement

2071784

510 (k) Number (if known):

Device Name:

DePuy Pinnacle® with Gription " Acetabular Cups

#### 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.

Pinnacle® Acetabular Cups are indicated for total hip replacement 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.

Porous-coated Pinnacle® Acetabular Cups are indicated for cementless application.

Prescription Use X (Part 21 CFR 801 Subpart D)

510(k) Num

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*(Posted November 13, 2003)* Page 1 of 1

(Division Sign-O Division of General, Restorative. and Neurological Devices

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