DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS

K090998 · DePuy Orthopaedics, Inc. · JDI · Jun 12, 2009 · Orthopedic

Device Facts

• Record ID: K090998
• Device Name: DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Jun 12, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pinnacle 100 with Gription Acetabular Cup is indicated for use as part of the acetabular portion of a total hip replacement. 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. Porous-coated Pinnacle Acetabular Cups are indicated for cementless applications. 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.

Device Story

Modular acetabular component for total hip replacement; consists of titanium alloy (Ti-6Al-4V) hemispherical shell with proprietary Gription porous coating and UHMWPE or CrCoMo liner. Implanted by orthopedic surgeons in clinical/OR settings. Device replaces damaged hip joint articulation to restore mobility and reduce pain. Cementless application relies on bone ingrowth into porous coating for fixation. Output is a functional prosthetic joint interface.

Clinical Evidence

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

Technological Characteristics

Acetabular shell: Titanium alloy (Ti-6Al-4V) with Gription porous coating. Liner: UHMWPE or CrCoMo. Modular design for cementless fixation. No software or electronic components.

Indications for Use

Indicated for patients requiring total hip replacement due to osteoarthritis, traumatic/rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, acute traumatic fracture, failed previous hip surgery, or ankylosis. Intended for cementless applications in patients with sufficient sound bone to support components.

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 with Gription Acetabular Cups (K071784)
• Pinnacle Acetabular System (Porocoat) (K001534)

Submission Summary (Full Text)

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510 (k) Summary

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

DePuy Orthopaedics, Inc.

JUN 1 2 2009

#### NAME OF SPONSOR:

510(K) CONTACT:

DATE PREPARED:

COMMON NAME:

CLASSIFICATION:

PROPRIETARY NAME:

700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910

Rhonda Myer Senior Regulatory Affairs Associate Telephone: [phone] Facsimile: [phone] Electronic Mail: [e-mail]

May 13, 2009

DePuy Pinnacle® 100 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

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

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

Class II per 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis

#### DEVICE PRODUCT CODE:

#### SUBSTANTIALLY EQUIVALENT DEVICES:

Pinnacle with Gription Acetabular Cups, K071784 (July 25, 2007) Pinnacle Acetabular System (Porocoat), K001534 (June 12, 2000)

KWA, JDI, LZO and LPH

DePuy Orthopaedics, Inc.

K090998: Additional Information Pinnacle 100 with Gription

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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 polyetheylene (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. The subject acetabular cup is coated with a proprietary titanium porous coating, Gription.

#### INDICATIONS AND INTENDED USE:

#### Indications:

The Pinnacle 100 with Gription Acetabular Cup is indicated for use as part of the acetabular portion of a total hip replacement.

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

#### 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.

#### BASIS OF SUBSTANTIAL EQUIVALENCE:

The Pinnacle 100 with Gription Acetabular Cup is substantially equivalent in geometry to the Pinnacle 100 Acetabular Cups (with Porocoat) cleared in K001534, and substantially equivalent in porous coating to the Pinnacle Cups with Gription cleared in K071784 based on similarities in intended use, indications for use, material, design, sterilization, packaging and method of manufacturing.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 2 2009

DePuy Orthopaedics, Incorporated c/o Ms. Rhonda Myer Senior Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46582 ·

Re: K090998

Trade/Device Name: DePuy Pinnacle 100 with Gription Acetabular Cups Regulation Number: 21 CFR 888.3330

Regulation Name: Hip Joint Metal/Metal Semi-Constrained, With an Uncemented Acetabular Component, Prosthesis

Regulatory Class: Class iII Product Code: KWA, JDI, LZO, LPH Dated: May 14, 2009 Received: May 15, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting

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Page 2-Ms. Rhonda Myer

(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Вавене Внелит

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

Enclosure

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# 1090998

### Indications for Use Statement

510 (k) Number (if known): K090998

#### DePuy Pinnacle® 100 with Gription™ Acetabular Cup Device Name:

Indications for Use:

The Pinnacle 100 with Gription Acetabular Cup is indicated for use as part of the acetabular portion of a total hip replacement.

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.

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

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

Jauta
(Division Sign-Off)

for

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090998