A severely painful and/or disabled joint 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 arthroplasty, or total hip replacement.
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 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.

AI/ML Overview

This document is a 510(k) summary for a medical device called the DePuy Pinnacle® 100 with Gription™ Acetabular Cups. It does not describe a study involving AI or machine learning, nor does it provide acceptance criteria or performance data in the typical sense of algorithm evaluation.

Instead, this document is a regulatory submission demonstrating substantial equivalence to previously approved devices. This means the manufacturer is asserting that their new device is as safe and effective as devices already on the market, based on similarities in intended use, indications for use, material, design, sterilization, packaging, and manufacturing methods.

Therefore, most of the requested information about acceptance criteria, performance, sample sizes, ground truth establishment, and expert involvement for an AI study is not applicable to this document.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. This document is not a study reporting on the performance of an AI or diagnostic algorithm against specific acceptance criteria. It's a regulatory submission for a physical medical device. The "acceptance criteria" here are implicitly the FDA's requirements for demonstrating substantial equivalence.

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

Not applicable. There is no "test set" in the context of an algorithm evaluation. The device itself is the product being reviewed.

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

Not applicable. There is no "ground truth" established by experts in the context of an algorithm's performance. The safety and effectiveness of the physical device are evaluated based on its design, materials, and comparison to predicate devices, not through expert-labeled data.

4. Adjudication Method for the Test Set:

Not applicable. No test set or expert adjudication related to algorithm performance.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study:

No. This document does not mention or describe an MRMC study.

6. Standalone Performance Study (Algorithm Only):

No. This device is a physical acetabular cup, not a standalone algorithm.

7. Type of Ground Truth Used:

Not applicable. Ground truth is not a concept pertinent to this type of device submission. The FDA evaluates the device based on its design specifications, materials testing, and comparison to predicate devices.

8. Sample Size for the Training Set:

Not applicable. There is no training set as this is not an AI/ML algorithm.

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

Not applicable. There is no training set or ground truth in the context of AI/ML.

Summary based on the document:

This document is a 510(k) Pre-market Notification for a medical device (DePuy Pinnacle® 100 with Gription™ Acetabular Cups). The basis of approval is Substantial Equivalence to previously cleared devices (Pinnacle 100 Acetabular Cups with Porocoat K001534 and Pinnacle Cups with Gription K071784). The manufacturer asserts equivalence based on similarities in intended use, indications for use, material, design, sterilization, packaging, and manufacturing method. This type of submission does not involve performance studies of AI algorithms against defined acceptance criteria, nor does it rely on human readers, ground truth datasets, or training sets in the way an AI/ML device would.

Summary

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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: (574) 371-4927 Facsimile: (574) 371-4987 Electronic Mail: Rmyer7@its.jnj.com

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:

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:

A severely painful and/or disabled joint 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.

Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

1. Certain cases of ankylosis.
  Porous-coated Pinnacle Acetabular Cups are indicated for cementless applications.

Intended Use:

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 (800) 638-2041 or (240) 276-3150 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.
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 arthroplasty, or total hip replacement.
1. 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

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.