PINNACLE ACETABULAR SYSTEM

K000306 · DePuy Orthopaedics, Inc. · LPH · Mar 23, 2000 · Orthopedic

Device Facts

• Record ID: K000306
• Device Name: PINNACLE ACETABULAR SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Mar 23, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pinnacle Acetabular System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. All Pinnacle porous-coated acetabular shells are indicated for cementless application.

Device Story

Pinnacle Acetabular System is a modular hip joint prosthesis for total hip replacement or revision. Device consists of a porous-coated hemispherical outer shell (titanium alloy Ti-6Al-4V) and a locking liner (UHMWPE). Liner articulates with a femoral head. System is implanted by surgeons in clinical settings to replace damaged hip joints, addressing pain and disability. Modular design allows for cementless application. Output is a reconstructed hip joint interface, restoring joint function and mobility for patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and manufacturing similarities to the predicate device.

Technological Characteristics

Modular acetabular cup prosthesis. Outer shell: titanium alloy (Ti-6Al-4V). Liner: ultra high molecular weight polyethylene (UHMWPE). Cementless application. Hemispherical form factor. Mechanical locking mechanism between shell and liner.

Indications for Use

Indicated for patients requiring total hip replacement or revision due to severe pain/disability from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, femoral fracture nonunion, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, or previous fusion with inadequate bone stock.

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

• SUMMIT Acetabular System

Submission Summary (Full Text)

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MAR 2 3 : :

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## SUMMARY OF SAFETY AND EFFECTIVENES DePuv Orthopaedics, Inc.

| NAME OF FIRM: | DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, IN 46581-0988 | PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 USA Tel: [phone] Fax: [phone] |
|-----------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Lynnette Whitaker Group Leader, Regulatory Affairs | |
| TRADE NAME: | Pinnacle Acetabular System | |
| COMMON NAME: | Acetabular Cup Prosthesis | |
| CLASSIFICATION: | 888.3358 Hip joint metal/polymer semi-constrained cementless prosthesis | |
| DEVICE PRODUCT CODE: | 87 LPH | |
| SUBSTANTIALLY EQUIVALENT DEVICES: | SUMMIT TM Acetabular System | |

## DEVICE DESCRIPTION AND INTENDED USE:

The Pinnacle Acetabular System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

All Pinnacle porous-coated acetabular shells are indicated for cementless application.

The Pinnacle Acetabular System is part of a modular system for use 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 ultra high molecular weight polyetheylene (UHMWPE), which locks into the outer shell. The liner component articulates with a femoral head of an appropriate diameter.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The Pinnacle Acetabular System has the following similarities to the acetabular cup liners that were cleared in K983014: same intended use; same material; same method of manufacture; same design; same sterilization and packaging methods. The Pinnacle Acetabular System demonstrated equivalent performance to the predicate device.

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MAR 2 3 200(

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lynnette Whitaker Group Leader, Regulatory Affairs Depuy Orthopedics, Inc. P.O. Box 988 700 Orthopedic Drive Warsaw, Indiana 46581-0988

Re: K000306

Trade Name: Pinnacle Acetabular System Regulatory Class: II Product Code: LPH Dated: Febrary 24, 2000 Received: Febrary 28, 2000

Dear Ms. Whitaker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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MAR 2 3 2000

Page 2 - Ms. Lynnette Whitaker

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (2017) 594-4639. Natinonally 120-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsionnes and in the research and except of at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Kim C. Yeager

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

Enclosure

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KUDO306

510(k) Number (if known)_Kooo} ab

Device Name Pinnacle Acetabular System

Indications for Use:

The Pinnacle Acetabular System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the nevious hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

All Pinnacle porous-coated acetabular shells are indicated for cementless application.

Concurrence of CDRH, Office of Device Evaluation

Ticnel' Jayan.

(Division Sigri-Off) Division of Ceneral Restorative Devices Koriso 510(k) Number __

Prescription Use no (Per 21 CFR 801.109)

OR

Over-The Counter Use

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