PINNACLE REVISION SYSTEM

K033338 · DePuy Orthopaedics, Inc. · LPH · Jan 8, 2004 · Orthopedic

Device Facts

• Record ID: K033338
• Device Name: PINNACLE REVISION SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jan 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. The Pinnacle Revision System is intended to be used to resurface the Acetabular socket in cementless total hip arthroplasty.

Device Story

Pinnacle Revision System is a modular acetabular cup prosthesis for cementless total hip arthroplasty. System comprises titanium alloy (Ti-6Al-4V) shells with Porocoat porous coating and UHMWPE liners. Shells feature multihole, standard, and deep profile (DPx) configurations for lateralization and screw fixation. Liners include anti-rotation devices for variable alignment. Device is implanted by orthopedic surgeons in an operating room setting to replace damaged hip joint articulation. Benefits include increased patient mobility and pain reduction through stable, cementless fixation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Modular acetabular cup prosthesis. Shell: Forged/wrought titanium alloy (Ti-6Al-4V) with Porocoat (commercially pure titanium beads). Liner: UHMWPE. Features: Multihole, standard, and deep profile configurations; peripheral and dome screw holes; apical threaded hole for insertion instrument. Cementless application.

Indications for Use

Indicated for total hip replacement in patients with severely painful/disabled joints due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head/neck, failed previous hip surgery (reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement, or total hip replacement), or ankylosis. Indicated for cementless application.

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 System
• Summit™ Acetabular System
• DePuy Duraloc® Cementless Acetabular Cup System
• Marathon™ Cross-Linked Polyethylene Acetabular Cup Liners
• 36mm Marathon™ +4 Polyethylene Liners
• Modified DePuy Acetabular System

Submission Summary (Full Text)

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JAN - 8 2004

033338
page 1 of 2

# 510(k) Summary NAME OF SPONSOR: DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Est. Reg. No. 1818910 510(K) CONTACT: Bob Friddle, BSMF Consultant, Regulatory Affairs Telephone: [phone] Fax: [phone] DATE PREPARED: November 18, 2003 TRADE NAME: PinnacleTM Revision System COMMON NAME: Acetabular Cup Prosthesis CLASSIFICATION: Class II Device per 21 CFR 888.3358: Hip joint metal/polymer/metal semiconstrained porous coated uncemented prosthesis DEVICE PRODUCT CODE: 87 LPH SUBSTANTIALLY EQUIVALENT DePuy Pinnacle™ Acetabular System DEVICES: Summit™ Acetabular System DePuy Duraloc® Cementless Acetabular Cup System DePuy Duraloc® Cementless Acetabular Cup System Marathon™ Cross-Linked Polyethylene Acetabular Cup Liners 36mm Marathon™ +4 Polyethylene Liners Modified DePuy Acetabular System

# DEVICE DESCRIPTION:

The Pinnacle™ Revision System is a modular system for resurfacing the acetabulum in total hip arthroplasty. It is a line extension of the DePuy Pinnacle™ Acetabular System. The system consists of two separate units, a shell and a liner. The shell substrate is manufactured from forged or wrought titanium alloy (Ti-6AL-4V). The outer porous-coating (Porocoat®) consists of commercially pure titanium beads metallurgically bonded to the shell substrate. The interior of the shell is designed to mate with a variety of styles of liners that lock into the liner is manufactured from Ultra-high molecular weight polyethylene (UHMWPE). The liners contain multiple ARDs (anti-rotation devices) that engage mating shell features to prevent rotation within the shell. The ARDs enable variable rotational alignment of Face Changing (+4 / 10°) and Lipped liners for patient appropriate positioning. The acetabular liner articulates with a compatible femoral head of appropriate diameter.

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033338
page 2 of 2

## 510(k) Summary (cont.)

The Pinnacle™ Revision System extends the existing Pinnacle™ Acetabular System shell options by providing Multihole, Standard Profile and DPx (Deep Profile) configurations. The Revision DPx Shells provide lateralization of the femoral head. Both Revision Standard Profile and Revision DPx shells provide peripheral screw holes in addition to dome screw holes. The screw holes permit use of compatible titanium alloy screws to provide immediate adjunct fixation, stability and intimate contact with bone. The shells contain an apical threaded hole to attach the shell insertion instrument and grasp the shell during implantation. An optional titanium alloy (Ti-6Al-4V) apical hole plug is available to screw into the threaded apical hole of the shell.

The Pinnacle™ Revision System extends the range of Pinnacle™ Marathon Liners by offering corresponding sizes for 28, 32 and 36mm femoral heads in Neutral, +4, and +4 / 10' degree configurations and a Lipped liner configuration for 28 and 32mm femoral heads.

### INTENDED USE AND INDICATIONS:

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. The Pinnacle Revision System is intended to be used to resurface the Acetabular socket in cementless total hip arthroplasty.

The Pinnacle™ Revision System is indicated for total hip replacement in the following conditions:

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

The Pinnacle™ Revision System Acetabular Cup Shell components are indicated for cementless application.

### BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on the same Intended Use, Indications for Use, materials, sterilization processes and similarities of technological and geometric features, DePuy believes that the subject Pinnacle™ Revision System components are substantially equivalent to the previously cleared DePuy predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three legs, representing the department's mission related to health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 8 2004

Ms. Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K033338 Trade/Device Name: Pinnacle™ Revision System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymet/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPI Dated: December 11, 2003 Received: December 12, 2003

Dear Ms. Heck:

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 Mcdical 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 may of bather to saterial 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 (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. Natalie Heck

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will anow yourse ough finding of substantial equivalence of your device to a legally premantee notification "The 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 If you desire specific acrioliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorination of Journer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known): Device Name: Pinnacle™ Revision System

## Intended Use/Indications for Use

Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. The Pinnacle Revision System is intended to be used to resurface the Acetabular socket in cementless total hip arthroplasty.

The Pinnacle" Revision System is indicated for total hip replacement in the following conditions:

- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, l. rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head or neck. 3.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.

The Pinnacle™ Revision System Porocoat® porous-coated Acetabular Cup Shell components arc indicated for cementless application.

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED. Concurrence of CDRH, Office of Device Evaluation (ODE)

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for K033338

ision Sign-Off)
ision of General, Restorative
Neurological Devices

K033338

Number

K0553

Prescription Use X OR Over-The-Counter Use
(Per 21 CFR 801.109)