DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS

K093646 · DePuy Orthopaedics, Inc. · JDI · Dec 17, 2009 · Orthopedic

Device Facts

• Record ID: K093646
• Device Name: DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Dec 17, 2009
• Decision: SESE
• Submission Type: Special
• 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. 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 total hip replacement system component. Device consists of a hemispherical titanium alloy (Ti-6Al-4V) outer shell with proprietary Gription™ porous coating and a liner (UHMWPE or CrCoMo). Used in total hip arthroplasty to replace damaged hip joint articulation. Implanted by orthopedic surgeons in a clinical/surgical setting. Fixation achieved via biological tissue ingrowth into the porous coating. Provides increased patient mobility and pain reduction by restoring joint function.

Clinical Evidence

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

Technological Characteristics

Acetabular cup system. Materials: Titanium alloy (Ti-6Al-4V) shell with Gription™ porous coating; liners of UHMWPE or high-carbon cobalt chrome (CrCoMo). Uncemented, porous-coated design for biological fixation. Modular component for total hip arthroplasty.

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 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

• Pinnacle 100 with Gription Acetabular Cups (K090998)
• Pinnacle with Gription Acetabular Cups (K071784)

Submission Summary (Full Text)

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K09364/6

# DEC 1 7 2009

### 510 (k) Summary

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

NAME OF SPONSOR:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910

510(K) CONTACT:

DATE PREPARED: PROPRIETARY NAME:

COMMON NAME:

CLASSIFICATION:

Rhonda Myer Senior Regulatory Affairs Associate

Telephone: [phone] Facsimile: [phone] Electronic Mail: rmyer7(@its.jnj.com

December 15, 2009

## DePuy Pinnacle® with Gription™ Acetabular Cups

Acetabular Cup with Porous Coating

Class III per 21 CFR 888.3330: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (KWA)

Class II per 21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis (JDI)

Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (LZO)

Class II per 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis (LPH)

#### DEVICE PRODUCT CODE:

SUBSTANTIALLY EQUIVALENT DEVICE:

KWA, JDI, LZO, LPH

Pinnacle 100 with Gription Acetabular Cups, K090998, cleared on June 12, 2009 Pinnacle with Gription Acetabular Cups, K071784, cleared on July 25, 2007

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#### 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 polyethylene (UHMWPE) or high-carbon cobalt chrome (CrCoMo), both of which lock into the outer shell. The liner component articulates with a femoral head of an appropriate diameter. which mates with a compatible DePuy femoral stem. The subject acetabular cups are coated with a proprietary titanium porous coating, Gription™.

### INDICATIONS AND INTENDED USE:

#### Indications:

The Pinnacle Acetabular Cups are indicated for total hip replacement in the following conditions:

- 1. A severely painful and/or a severely disabled joint resulting 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 arthoplasty, or other total hip replacement; and
- 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 subject Pinnacle with Gription Acetabular Cups are identical to those cleared in K071784. The only change proposed is to add three FDA classifications to the classification cleared in K071784 (LPH) so that the classifications for all Pinnacle with Gription Cups are the same as those cleared for the Pinnacle 100 with Gription Cups in K090998 (LPH, KWA, JDI, LZO). Based on the similarities in intended use, indications for use, materials, method of manufacturing, design, sterilization and

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packaging method, the subject cups are substantially equivalent to the Pinnacle 100 with Gription Acetabular Cups cleared in K090998.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Senior Regulatory Affairs Associate PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46582-0988

### DEC 1 7 2009

Re: K093646

> Trade/Device Name: DePuy Pinnacle with Gription Acetabular Cups Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular, prosthesis

Regulatory Class: Class III Product Code: KWA, JDI, LZO, LPH Dated: November 23, 2009 Received: November 25, 2009

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 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

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Page 2 - Ms. Rhonda Myer

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

Enclosure

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# Indications for Use Statement

510 (k) Number (if known): K093646

Device Name: DePuy Pinnacle with Gription Acetabular Cups

#### Indications for Use:

DePuy Pinnacle with Gription Acetabular Cups are indicated for total hip replacement in the following conditions:

- 1. A severely painful and/or a severely disabled joint resulting 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;
- 3. Freated previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and
- 5. Certain cases of ankylosis.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/CIR

(21 CFR 807 Subpart C)

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(Division Sign-Off) D. media

(Division Sign of Surgical, Orthopedic, Divisionative Devices

510(k) Number K093646

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DePuy Orthopedics, Inc.

Pinnacle with Gription: Special 510(k)