A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia:
Avascular necrosis of the femoral head;
Acute traumatic fracture of the femoral head or neck;
Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
Certain cases of ankylosis.
Porous-coated Pinnacle Acetabular Cups are indicated for cementless application.

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™.

AI/ML Overview

This document is a 510(k) summary for the DePuy Pinnacle® with Gription™ Acetabular Cups. It is important to note that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical studies with detailed acceptance criteria and performance data like those for novel devices or PMAs.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not contain specific quantitative acceptance criteria (e.g., specific thresholds for wear rates, pull-out strength, etc.) or a quantitative performance report of the device against such criteria. The basis for substantial equivalence is primarily through comparison to previously cleared predicate devices.

The "device performance" described is largely qualitative, focusing on equivalence to predicate devices in terms of:

Intended use
Indications for use
Materials
Method of manufacturing
Design
Sterilization
Packaging method

The core of this 510(k) states: "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... 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..."

Therefore, the acceptance criteria implicitly involve demonstrating that the device is identical or substantially equivalent to previously cleared devices in these qualitative aspects, and that the expanded classification does not alter the fundamental safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This 510(k) is a "Special 510(k)" based on a minor change (adding classification codes) to an already cleared device, and relies on substantial equivalence. It does not present a new study with a "test set" in the context of clinical or performance data for a novel device. The "data provenance" would refer back to the original predicate device clearances (K071784 and K090998), which would have had their own data supporting their clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This document does not describe a study involving a "test set" and expert ground truth establishment for performance evaluation.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. This 510(k) is for an orthopedic implant and does not involve AI or image reading, so an MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This applies to AI/software as a medical device, which is not the case here.

7. Type of Ground Truth Used

Not applicable in the context of a de novo performance study. The "ground truth" for this submission is effectively the established safety and effectiveness of the existing predicate devices (K071784 and K090998) through their prior clearance processes, which would have been based on a combination of engineering testing, materials characterization, and potentially pre-clinical or clinical data if required at the time and for the specific device types.

8. Sample Size for the Training Set

Not applicable. There is no AI component or "training set" described in this submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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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: (574) 371-4927 Facsimile: (574) 371-4987 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

p 1 of 3

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DEVICE DESCRIPTION:

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:
1. Avascular necrosis of the femoral head;
1. Acute traumatic fracture of the femoral head or neck;
1. Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
1. 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.

p. 3 of 3

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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 (800) 638-2041 or (301) 796-7100 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:
1. Avascular necrosis of the femoral head;
1. Acute traumatic fracture of the femoral head or neck;
1. Freated previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and
1. 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)

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

Smita for nxm
(Division Sign-Off) D. media

(Division Sign of Surgical, Orthopedic, Divisionative Devices

510(k) Number K093646

p. 1 of 1

DePuy Orthopedics, Inc.

Pinnacle with Gription: Special 510(k)

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.