The Pinnacle AltrX™ Acetabular Cup Liners are indicated for use in total hip replacement procedures. 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. 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.
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 the Pinnacle Acetabular Cups in cementless applications.

Device Description

The Pinnacle AltrX Acetabular Cup Liner is part of a modular system designed to replace the natural articular surface of the hip joint 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 cross-linked ultra high molecular weight polyethylene (UHMWPE), which locks into the outer shell. The liner component articulates with a 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 liners have inner diameters (ID) intended for use with modular, unipolar, self-centering (bipolar), M-Spec or ceramic femoral heads within the 28mm-48mm size range. The outer diameters (OD) are geometrically the same as other Pinnacle Acetabular Cup Liners, in a 44mm-76mm size range offering.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Claim)	Reported Device Performance (AltrX™ UHMWPE liners)	Control (Marathon® UHMWPE liners)	Control (Enduron® UHMWPE liners)
Reduce wear by 53% compared to previously cleared DePuy Marathon® UHMWPE liners.	3.4 ± 0.2 mg/million cycles (mg/MC)	7.3 ± 1.0 mg/MC	-
Reduce wear by 92% compared to previously cleared conventional non-crosslinked UHMWPE liners.	3.4 ± 0.2 mg/MC	-	43.6 ± 5.0 mg/MC
Maintain similar physical and mechanical properties as Marathon® UHMWPE.	"Mechanical testing shows that the AltrX liners perform similarly to the Marathon liners."	(Not explicitly quantified in terms of specific property values in this summary)	-

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

Sample Size: The text mentions "test devices identified as AltrX™ Polyethylene liners and two control devices identified as Marathon® Polyethylene liners and Enduron® Polyethylene liners." However, the exact number of individual liners tested for each group in the hip simulator wear study is not explicitly stated. The wear rates are provided with standard deviations (e.g., 3.4 ± 0.2 mg/MC), which suggests multiple samples were tested and averaged, but the count is missing.
Data Provenance: The study was an in-vitro hip simulator wear study. As such, there is no human patient data and therefore no specific country of origin or retrospective/prospective classification.

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

This question is not applicable. The study is an in-vitro mechanical wear study, not an assessment requiring expert interpretation of medical images or patient outcomes. The "ground truth" is established by the physical measurement of wear in a standardized laboratory setting.

4. Adjudication Method for the Test Set

This question is not applicable. There was no expert adjudication process for this type of in-vitro mechanical study. The wear measurements were objective.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This question is not applicable. This is not an AI-assisted diagnostic or imaging device. It is a medical implant, and the study focuses on its material properties and wear performance.

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

This question is not applicable. This is not an algorithmic device. The performance refers to the physical properties of the acetabular cup liner.

7. The Type of Ground Truth Used

Ground Truth Type: Objective, quantitative measurement of material degradation (wear rate) under simulated physiological conditions.

8. The Sample Size for the Training Set

This question is not applicable. There is no machine learning or AI component to this device, and thus no training set in the typical sense. The "training" in this context would be the development and manufacturing processes of the material itself.

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

This question is not applicable for the reasons stated above. The "ground truth" for the material development would have been established through iterative material science and engineering principles, with testing on prototypes, rather than a formal "training set" with established ground truth labels as seen in AI/ML applications.

Summary

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K06Z148

SUMMARY OF SAFETY AND EFFECTIVENESS

OCT 2 4 2006

NAME OF FIRM:	DePuy Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46581-0988
510(k) CONTACT:	Anne M. SchulerSr Regulatory Affairs Associate
DATE PREPARED:	October 23, 2006
TRADE NAME:	DePuy Pinnacle® AltrX™ Acetabular Cup Liner
COMMON NAME:	Acetabular Cup Liner
CLASSIFICATION:	CFR 888.3358 Hip joint metal/polymer/metal,semi-constrained, porous-coated, uncementedprosthesis, Class II deviceCFR 888.3353 Hip joint metal/ceramic/polymersemi-constrained cemented or non-porousuncemented prosthesis, Class II device
DEVICE PRODUCT CODE:	87 LPH, LZO
SUBSTANTIALLY EQUIVALENTDEVICE:	DePuy Pinnacle® Acetabular Cup System ESLMarathon™ Polyethylene liners (K033273,cleared May 6, 2004)DePuy Pinnacle® Acetabular System (K000306,cleared March 23, 2000)

Wright Medical LINEAGE® A-CLASS™ Poly Liner (K052026, cleared Dec 5, 2005)

DEVICE INFORMATION:

A. DEVICE DESCRIPTION

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manufactured from cross-linked ultra high molecular weight polyethylene (UHMWPE), which locks into the outer shell. The liner component articulates with a 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 liners have inner diameters (ID) intended for use with modular, unipolar, self-centering (bipolar), M-Spec or ceramic femoral heads within the 28mm-48mm size range. The outer diameters (OD) are geometrically the same as other Pinnacle Acetabular Cup Liners, in a 44mm-76mm size range offering,

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

AltrX™ UHMWPE liners reduce wear by 53% compared to previously cleared DePuy Marathon® UHMWPE liners while maintaining similar physical and mechanical properties as Marathon® UHMWPE. In addition. AltrX™ UHMWPE liners reduce wear by 92% compared to previously cleared conventional noncrosslinked UHMWPE liners.

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 two control devices identified as Marathon® Polyethylene liners and Enduron® Polyethylene liners. The test and control liners were manufactured by DePuv Orthopaedics by a ram extrusion process. The test and control liners had a thickness of 0.374 inches with a 28mm inner diameter and were gas plasma sterilized prior to the study.

Test and control liners were tested for 6 million cycles using an orbital bearing hip wear test machine manufactured by Shore Western Manufacturing Inc. The articulating component for both the test and control liners was a 28mm CoCr femoral head manufactured by DePuy Orthopaedics. 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 43.6 + 5.0 mg/million cycles (mg/MC) for the Enduron control, 7.3 ± 1.0 mg/MC for the Marathon control and 3.4 ± 0.2 mg/MC for the AltrX test material.

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

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B. INTENDED USE AND INDICATIONS

Intended Use

The subject Pinnacle AltrX UHMWPE Liners are intended to be used with the DePuy Pinnacle metal acetabular shells, modular femoral heads, unipolar femoral heads, M-Spec heads, bi-polar self-centering heads and ceramic heads to resurface the acetabular socket in cementless total hip arthroplasty.

Indications

The Pinnacle AltrX Acetabular Cup Liner is indicated for use in total hip replacement procedures. 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. 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.

The Pinnacle AltrX is indicated for use with the Pinnacle Acetabular Cup in cementless application.

C. BASIS OF SUBSTANTIAL EQUIVALENCE:

The Pinnacle AltrX Acetabular Cup Liners have the same design, intended use, manufacturing method, sterilization and packaging as the Pinancle Marathon Acetabular Liners cleared in K033273 and K000306. Mechanical testing shows that the AltrX liners perform similarly to the Marathon liners and exhibit less wear in hip simulator testing. Based on similarities in design, intended use, manufacturing method, sterilization and packaging DePuy believes that the Pinnacle® AltrX™ Acetabular Cup Liners are substantially equivalent to the previously cleared Pinnacle® Marathon™ Liners and to the previously cleared Wright Medical LINEAGE® A-CLASS™ Poly Liner which is similar in design, manufacturing method and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Anne M. Schuler Sr. Regulatory Affairs Associate P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana

OCT 8 4 2006

Re: K062148 Trade/Device Name: DePuy Pinnacle Altrx™ Acetabular Cup 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: July 26, 2006 Received: July 27, 2006

Dear Ms. Schuler:

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. Insting 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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Page 2 -- Ms. Anne M. Schuler

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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

Ron Kirk

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

K062148

510(k) Number (if known): __ Ko 6 >14 8
Device Name: __ DePuv Pinnacle AltrXTMAce Device Name: DePuy Pinnacle AltrX™Acetabular Cup Liners

Indications for Use:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid 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.

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

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 807 Subpart C)	No
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

(Division Sign-Off)

Division of Generen Restorative, Office of Device Evaluation (ODE)

and Neurological Devices

510 k02214/

0000003

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.