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.

Device Description

The DePuy Pinnacle ALTRX Acetabular Liners are 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-6Al-4V). The liner component articulates with a metal or ceramic femoral head of an appropriate diameter. The subject devices represent additional sizes and style combinations of the predicate acetabular liners.

AI/ML Overview

The DePuy Pinnacle ALTRX Acetabular Liners are a medical device used in total hip replacement procedures. The 510(k) summary provides information on the device's acceptance criteria and the study that proves it meets these criteria.

Acceptance Criteria and Device Performance

The acceptance criteria for the DePuy Pinnacle ALTRX Acetabular Liners are implicitly demonstrated by showing substantial equivalence to legally marketed predicate devices. The study conducted was a non-clinical test that focused on specific performance requirements.

Here's a table summarizing the characteristics of the subject device in comparison to its predicate and reference devices, which effectively serve as the acceptance criteria based on equivalence:

Characteristic	Acceptance Criteria (Predicate/Reference)	Reported Device Performance (Subject Device)
Intended Use	Total Hip Arthroplasty	Total Hip Arthroplasty (Same)
Material	UHMWPE, GUR 1020 (Predicate)/GUR 1050 (Reference)	UHMWPE, GUR 1020
Fixation	Uncemented	Uncemented (Same)
Compatible Acetabular Shell Diameters	44-76 mm (Predicate), 38-76 mm (Reference)	52-76 mm (New sizes added within acceptable range)
Compatible Femoral Head Diameters	28, 32, 36, 40, 44, and 48 mm (Predicate/Reference)	28, 32, 36, and 40 mm (Subset of compatible sizes)
Minimum Cross-sectional Thickness	3.14 mm (Predicate), 3.25 mm (Reference)	3.05 mm (Slightly thinner but justified by testing)
Sterile Method	Gas Plasma	Gas Plasma (Same)
Packaging	Double PETG blister with Tyvek peel lid	Double PETG blister with Tyvek peel lid (Same)
Shelf Life	5 years	5 years (Same)
Impingement Performance	Met applicable performance requirements (implied by predicate clearance)	Demonstrated to meet applicable performance requirements
High Angle Fatigue Performance	Met applicable performance requirements (implied by predicate clearance)	Demonstrated to meet applicable performance requirements
Push-out Performance	Met applicable performance requirements (implied by predicate clearance)	Demonstrated to meet applicable performance requirements
Torque-out Performance	Met applicable performance requirements (implied by predicate clearance)	Demonstrated to meet applicable performance requirements

The device performance, as reported, indicates that the subject devices "met the applicable performance requirements and are as safe and effective as a legally marketed device."

Study Details

Given that this is a 510(k) submission for a line extension, the primary "study" is a demonstration of substantial equivalence through non-clinical testing.

Sample size used for the test set and the data provenance:
- No specific sample sizes for test sets are provided in the document. The testing mentioned (Impingement, High Angle Fatigue, Push-out, and Torque-out) would involve specific numbers of physical samples of the liners and associated components, but these numbers are not detailed here.
- Data Provenance: The data is from non-clinical tests conducted by the manufacturer, DePuy Orthopaedics. The country of origin of the data is not explicitly stated but is implied to be within the company's testing facilities, likely in the US (Warsaw, IN). The tests are prospective in the sense that they were conducted for the purpose of this submission to demonstrate performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For non-clinical performance testing of medical devices like acetabular liners, the "ground truth" is typically established by engineering standards and validated test methodologies. There isn't a concept of medical "experts" establishing ground truth in the same way as, for example, reviewing medical images. The acceptance criteria for these tests (e.g., maximum force, cycles to failure) are derived from industry standards, regulatory requirements, and historical data from similar, cleared devices. The engineers and technicians who conduct and interpret these tests are qualified in biomechanical testing and materials science, but their specific number or qualifications are not provided here.
Adjudication method for the test set:
- Not applicable in the traditional sense. Non-clinical mechanical tests are generally quantitative, and their outcomes are determined by meeting predefined engineering specifications and statistical analysis, rather than through expert human adjudication.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- No, a MRMC comparative effectiveness study was explicitly stated as not conducted. The document states, "No clinical tests were conducted to demonstrate substantial equivalence." This type of study is typically used for diagnostic or screening devices involving human interpretation of data (e.g., radiology images).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant (acetabular liner) for hip replacement, not a software algorithm.
The type of ground truth used:
- The ground truth for the non-clinical tests (Impingement, High Angle Fatigue, Push-out, and Torque-out) is based on established engineering performance requirements and industry standards for such orthopedic implants. The reported performance of the subject device was compared against these predefined acceptable limits (derived from the predicate devices and general orthopedic device standards) to ensure it performs "as safe and effective as a legally marketed device."
The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

{0}------------------------------------------------

MAR 1 0 2014

Section 5: 510 (k) Summary

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

Submitter Information
Name	DePuy Orthopaedics
Address	700 Orthopaedic DriveWarsaw, IN 46582
Phone number	574-372-7745
Fax number	574-371-4987
Establishment RegistrationNumber	1818910
Name of contact person	Megan Burns
Date prepared	February 14, 2014
Name of device
Trade or proprietary name	DePuy Pinnacle ALTRX Acetabular Liners
Common or usual name	Polyethylene Acetabular Cup Liner
Classification name	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Class	II
Classification panel	Orthopedics
Regulation	21 CFR 888.3358: Hip joint metal/polymer/metal, semi-constrained,porous-coated, uncemented prosthesis21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrainedcemented or non-porous uncemented prosthesis
Product Code(s)	LPH, LZO
Legally marketed device(s) towhich equivalence is claimed	DePuy Pinnacle ALTRX Acetabular Liners(K102423, cleared October 29, 2010)
Reason for 510(k) submission	Line extension
Device description	The DePuy Pinnacle ALTRX Acetabular Liners are part of a modularsystem designed to replace the natural articular surface of the hip jointin total hip replacement. The liner is manufactured from ultra highmolecular weight polyethylene (UHMWPE), which locks into a porouscoated, hemispherical outer shell component manufactured fromtitanium alloy (Ti-6Al-4V). The liner component articulates with ametal or ceramic femoral head of an appropriate diameter. The subjectdevices represent additional sizes and style combinations of thepredicate acetabular liners.
Intended use ofthe device	The subject liners are intended to be used with the DePuy Pinnacle metalacetabular shells and DePuy metal or ceramic femoral heads to resurface theacetabular socket in cementless total hip arthroplasty. Total hip arthroplasty isintended to provide increased patient mobility and reduce pain by replacing thedamaged hip joint articulation in patients where there is evidence of sufficientsound bone to support the components.
Indications for use	The DePuy Pinnacle ALTRX Acetabular Cup Liners are indicated for use intotal hip replacement procedures.Total hip replacement is indicated in the following conditions:1. A severely painful and/or disabled joint from osteoarthritis, traumaticarthritis, 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, internalfixation, arthrodesis, hemiarthroplasty, surface replacementarthroplasty, or total hip replacement.5. Certain cases of ankylosis.The Pinnacle ALTRX Acetabular Cup Liners are indicated for use withPinnacle Acetabular Cups in cementless applications.

{1}------------------------------------------------

{2}------------------------------------------------

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICECOMPARED TO THE PREDICATE DEVICE
Characteristics	Subject Device:DePuy PinnacleALTRXAcetabular Liners	Predicate Device:DePuy PinnacleALTRX AcetabularLiners(K102423 andK072963)	Reference Device:DePuy PinnacleMarathon AcetabularLiners (K033273 and(K033338)
Intended Use	Total Hip Arthroplasty	Same	Same
Material	UHMWPE,GUR 1020	Same	UHMWPE,GUR 1050
Fixation	Uncemented	Same	Same
CompatibleAcetabular ShellDiameters	52-76 mm	44-76 mm	38-76mm
CompatibleFemoral HeadDiameters	28, 32, 36, and 40 mm	28, 32, 36, 40, 44, and 48mm	22, 28, 32, 36, 40, 44,and 48 mm
Minimum cross-sectionalthickness	3.05 mm	3.14 mm	3.25 mm
Sterile Method	Gas Plasma	Same	Same
Packaging	Double PETG blisterwith Tyvek peel lid	Same	Same
Shelf Life	5 years	Same	Same
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE
Non-clinical testing, including Impingement, High Angle Fatigue, Push-out and Torque-out testing

demonstrated that the subject devices met the applicable performance requirements and are as safe and effective as a legally marketed device. Therefore, the subject device is substantially equivalent to the predicate device.

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

No clinical tests were conducted to demonstrate substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject DePuy ALTRX Acetabular Liners are substantially equivalent to the predicate DePuy ALTRX Acetabular Liners.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The words are likely part of a document or sign, indicating an affiliation with a public health organization.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2014

DePuy Orthopaedics, Inc Ms. Megan Burns Senior Associate, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K132959

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, LZO Dated: December 19, 2013 Received: December 20, 2013

Dear Ms. Burns:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{4}------------------------------------------------

Page 2 - Ms. Megan Burns

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins

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

Enclosure

{5}------------------------------------------------

Section 4: Indications for Use Statement

K132959 510 (k) Number (if known): __

Device Name: DePuy Pinnacle AltrX Acetabular Liners

Indications for Use:

The DePuy 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.
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 Pinnacle Acetabular Cups in cementless applications.

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Elizabeth & Frank -S

(Division Sign-Off Division of Orthopedic Devices 510(k) Number: K132959

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.