DEPUY PINNACLE ALTRX ACETABULAR CUP LINER

K062148 · DePuy Orthopaedics, Inc. · LPH · Oct 24, 2006 · Orthopedic

Device Facts

• Record ID: K062148
• Device Name: DEPUY PINNACLE ALTRX ACETABULAR CUP LINER
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Oct 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Modular acetabular cup liner system for total hip replacement; replaces damaged hip joint articulation. Components: porous-coated titanium alloy (Ti-6Al-4V) outer shell; cross-linked UHMWPE liner. Liner locks into shell; articulates with modular femoral heads (28mm-48mm). Used in orthopedic surgery; implanted by surgeons. In-vitro hip simulator testing demonstrates reduced wear compared to conventional and previous cross-linked UHMWPE liners. Device provides increased patient mobility and pain reduction.

Clinical Evidence

Bench testing only. In-vitro hip simulator study (6 million cycles) compared AltrX liners to Marathon and Enduron controls. Wear rates: 3.4 ± 0.2 mg/MC (AltrX) vs 7.3 ± 1.0 mg/MC (Marathon) and 43.6 ± 5.0 mg/MC (Enduron). No clinical data provided; wear claims based on simulator results which may not predict clinical performance.

Technological Characteristics

Material: Cross-linked UHMWPE liner; Ti-6Al-4V titanium alloy shell. Dimensions: Liner ID 28mm-48mm; OD 44mm-76mm. Sterilization: Gas plasma. Energy source: N/A (mechanical). Connectivity: N/A. Design: Modular, cementless, semi-constrained.

Indications for Use

Indicated for total hip replacement in patients with sufficient sound bone to support components. Conditions: osteoarthritis, traumatic/rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, acute traumatic fracture of femoral head/neck, failed previous hip surgery (reconstruction, fixation, arthrodesis, hemiarthroplasty, surface replacement), or ankylosis. For use with Pinnacle Acetabular Cups in cementless applications.

Regulatory Classification

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.

Predicate Devices

• DePuy Pinnacle Acetabular Cup System ESL Marathon Polyethylene liners (K033273)
• DePuy Pinnacle Acetabular System (K000306)
• Wright Medical LINEAGE A-CLASS Poly Liner (K052026)

Submission Summary (Full Text)

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K06Z148

## SUMMARY OF SAFETY AND EFFECTIVENESS

OCT 2 4 2006

| NAME OF FIRM: | DePuy Orthopaedics, Inc.<br>P.O. Box 988<br>700 Orthopaedic Drive<br>Warsaw, IN 46581-0988 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Anne M. Schuler<br>Sr 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,<br>semi-constrained, porous-coated, uncemented<br>prosthesis, Class II device<br><br>CFR 888.3353 Hip joint metal/ceramic/polymer<br>semi-constrained cemented or non-porous<br>uncemented prosthesis, Class II device |
| DEVICE PRODUCT CODE: | 87 LPH, LZO |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE: | DePuy Pinnacle® Acetabular Cup System ESL<br>Marathon™ Polyethylene liners (K033273,<br>cleared May 6, 2004)<br><br>DePuy Pinnacle® Acetabular System (K000306,<br>cleared March 23, 2000) |

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

## DEVICE INFORMATION:

## A. 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

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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.
- 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- 5. 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 [phone]. 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 [phone] 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:

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:

- 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.

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

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(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/

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