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

The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cementless applications.

The subject liner is intended to be used with the DePuy Pinnacle metal acetabular shells, and DePuy metal or ceramic femoral heads to resurface the acetabular socket in cementless total hip arthroplasty. 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 DePuy Pinnacle AltrX Acetabular Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-6A1-4V). The liner component articulates with a metal or ceramic femoral head of an appropriate diameter.

The subject Pinnacle AltrX liners are cross-linked UHMWPE acetabular cup liners that are available in a neutral, lateralized neutral, lipped or lateralized face-changing orientation. The subject liners are intended for use with modular, self-centering (bipolar), M-Spec or ceramic femoral heads within the 28mm-48mm size range.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DePuy Pinnacle® AltrX™ Acetabular Liners. The submission aims to support a marketing claim regarding reduced wear when these liners are articulated against ceramic femoral heads.

Here's an analysis of the acceptance criteria and study as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific wear rate thresholds for the new claim. Instead, the claim is comparative: "Pinnacle AltrX UHMWPE liners (articulated against ceramic heads) reduce wear by 33% compared to articulation against cobalt-chromium heads."

Therefore, the success criteria for the study would be demonstrating this 33% reduction (or greater statistical significance) with the ceramic head articulation compared to cobalt-chromium heads.

Acceptance Criteria (Implied by Marketing Claim)	Reported Device Performance	Meets Acceptance Criteria?
Reduce wear by at least 33% for AltrX liners articulated against ceramic heads compared to articulation against cobalt-chromium heads (control group for this comparison would be AltrX against CoCrMo heads).	AltrX with 36mm CoCrMo femoral head (control for comparison): 4.99 ± 0.66 mg/million cycles (mg/MC) AltrX with 36mm ceramic femoral head (test group): 3.32 ± 0.38 mg/MC Calculation of reduction: ((4.99 - 3.32) / 4.99) * 100% = 33.47% reduction.	Yes

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

Sample Size: The study involved multiple groups of liners and femoral heads. While the exact number of individual devices per group isn't explicitly stated, the text mentions a "12-station orbital bearing hip simulator," which implies a certain capacity for simultaneous testing. The report provides mean and standard deviation for wear rates, indicating multiple samples were tested for each configuration.
Data Provenance: The study was an in-vitro hip simulator wear study. As such, there is no country of origin for patient data (as it's not patient data) and it is not retrospective or prospective in the clinical sense. It's a laboratory-based study.

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

Not applicable. This is an in-vitro mechanical wear study, not a study requiring expert clinical interpretation or ground truth establishment based on human observational data. The "ground truth" here is the measured wear rate in a standardized laboratory setting.

4. Adjudication Method for the Test Set

Not applicable. As this is an in-vitro mechanical wear study, there is no human adjudication of findings. The wear rates are determined by quantitative laboratory measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This is an in-vitro mechanical wear study, not a clinical study involving human readers or cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a conceptual sense, this was a "standalone" performance evaluation of the device's physical properties. The device's wear performance was measured directly in a simulated environment without human intervention influencing the wear measurement itself. It's not an AI algorithm, but rather a physical device being tested.

7. The Type of Ground Truth Used

The ground truth used was quantitative laboratory measurement of wear rates (mg/million cycles) from a standardized in-vitro hip simulator study.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" for an algorithm. The "training" for the device's design and manufacturing would involve engineering principles and previous material science studies, not a data-driven training set.

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

Not applicable, as there is no training set in the context of an algorithm. For material development and design, "ground truth" would be established through material testing, mechanical properties analysis, and prior scientific understanding of UHMWPE behavior under simulated joint loading.

Summary

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K072963 # 1/3

510 (k) Summary

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

NAME OF SPONSOR:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46582Establishment Registration Number: 1818910
510(K) CONTACT:	Rhonda MyerRegulatory Affairs AssociateTelephone: (574) 371-4927Facsimile: (574) 371-4987Electronic Mail: Rmyer7@dpyus.jnj.com
DATE PREPARED:	October 9, 2007
PROPRIETARY NAME:	DePuy Pinnacle® AltrX™ Acetabular Liners
COMMON NAME:	Polyethylene Acetabular Cup Liner
CLASSIFICATION:	Class II per 21 CFR 888.3358, Hip jointmetal/polymer/metal, semi-constrained, porouscoated, uncemented prosthesisClass II per 21 CFR 888.3353, Hip jointmetal/ceramic/polymer semi-constrainedcemented or non-porous uncemented prosthesis
DEVICE PRODUCT CODE:	87 LPH, LZO
SUBSTANTIALLY EQUIVALENTDEVICE:	DePuy Pinnacle® AltrX™ Acetabular Liners,K062148, October 24, 2006

DEVICE DESCRIPTION:

The subject Pinnacle AltrX liners are cross-linked UHMWPE acetabular cup liners that are available in a neutral, lateralized neutral, lipped or lateralized face-changing orientation. The

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K072913 * 2/3

subject liners are intended for use with modular, self-centering (bipolar), M-Spec or ceramic femoral heads within the 28mm-48mm size range.

The following marketing claim will be made for the Pinnacle Altrx liner:

Pinnacle AltrX UHMWPE liners (articulated against ceramic heads) reduce wear by 33% compared to articulation against cobalt-chromium heads.

An in-vitro hip simulator wear study was conducted to support these wear claims. The study was conducted using test devices identified as AltrX Polyethylene Liners and control devices identified as AltrX or Enduron™ Polyethylene Acetabular Cup Liners (inner diameter of 28 mm or 36 mm) used with DePuy cobalt chromium or Delta Ceramic Femoral Heads. The control devices are manufactured by DePuy Orthopaedics, Inc. of ram-extruded bars and machined into Pinnacle liners. The test devices are manufactured by DePuy Orthopaedics, Inc. of ram-extruded bars, irradiated to 7.5 Mrad in vacuum, remelted and machined into Pinnacle liners. The subject liners were not terminally sterilized prior to testing.

Test and control liners were tested for 5 million cycles using a 12-station orbital bearing hip simulator manufactured by Shore Western Manufacturing Inc. The thickness of the test liner was 5.53 mm. The heads were roughened after 5 million cycles by tumbling for 30 minutes with a bauxite/alumina abrasive media in a tabletop tumbler made by A.E. Aubin Co. and tested for an additional 2 million cycles against the liners. The articulating components for the test and control liners include 28 mm and 36 mm CoCrMo femoral heads, and 36 mm ceramic femoral heads. The lubricant used in the study was 90% bovine serum with 0.2% NaN3 and 20mM EDTA. The wear rates determined at the conclusion of the study were 34.3 ± .51 mg/million cycles (mg/MC) for the 28 mm CoCrMo femoral head/Enduron group (control), 31.54 ± 0.8 mg/MC for the 36 mm CoCrMo femoral head/Enduron group (control), 4.99 ± 0.66 mg/MC for the 36 mm CoCrMo femoral head/AltrX (control), and 3.32 ± 0.38 mg/MC for the 36 mm ceramic femoral head/AltrX test group.

Note: Reduced Wear Claims are based on the results of in-vitro hip wear simulator tests which have not been shown to quantitatively predict clinical wear performance

INDICATIONS AND INTENDED USE:

Indications:

The Pinnacle AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures.

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.

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1. Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery, including joint reconstruction, internal fixation, 4. arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cementless applications.

Intended Use:

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Pinnacle AltrX Acetabular Liner described in this submission is identical to the DePuy Pinnacle AltrX Acetabular Liner previously cleared in K062148 on October 24, 2006. The subject liners have not been modified from the previously cleared Pinnacle AltrX liners, and based upon the referenced testing, DePuy wishes to make a claim of reduced wear when the subject liners are used with ceramic femoral heads.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is made up of several curved lines, and the text is in a simple sans-serif font. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health and Human Services.

JAN - 9 2008

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Depuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, IN 46582

Re: K072963 Trade/Device Name: DePuy Pinnacle® Altrx™ Acetabular Liners 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: January 2, 2008 Received: January 3, 2008

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 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.

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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 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 (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Wilkerson

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

510 (k) Number (if known):	K072963
----------------------------	---------

DePuy Pinnacle® AltrX™ Acetabular Cup Liner Device Name:

Indications for Use:

The Pinnacle AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures.

Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic 1. arthritis, rheumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck. 3.
Failed previous hip surgery, including joint reconstruction, internal fixation, 4. arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
న్. Certain cases of ankylosis

The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cementless applications.

Prescription Use X(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 807 Subpart C)
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(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)

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Division of General, Restorative, and Neurological Devices

510(k) Number K072963

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

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