TRITANIUM ACETABULAR SHELL SYSTEM

K081171 · Howmedica Osteonics Corp. · LPH · Jul 22, 2008 · Orthopedic

Device Facts

• Record ID: K081171
• Device Name: TRITANIUM ACETABULAR SHELL SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Jul 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tritanium Acetabular Shell is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function.

Device Story

Tritanium Acetabular Shell System is a hemispherical, cementless hip replacement component; available in solid-backed or cluster screw-hole designs; sizes 44-72 mm OD. Features proprietary Particle Sintered Foam (PSF) porous metal coating for bone ingrowth. Used in primary and revision total hip arthroplasty to alleviate pain and restore function. Implanted by orthopedic surgeons in clinical/hospital settings. Device provides structural support and interface for polyethylene inserts; facilitates biological fixation to acetabulum. Benefits patients by restoring joint mobility and reducing pain associated with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material characteristics.

Technological Characteristics

Hemispherical acetabular shell; sizes 44-72 mm OD. Material features proprietary Particle Sintered Foam (PSF) porous metal coating for cementless fixation. Compatible with polyethylene Trident inserts. Device is a semi-constrained, porous-coated uncemented hip prosthesis.

Indications for Use

Indicated for patients with painful, disabling hip joint disease due to non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late-stage avascular necrosis; revision of failed femoral head replacement, shell arthroplasty, or other procedures; clinical management problems where arthrodesis or alternative reconstruction is less likely to succeed; or cases with poor bone stock/acetabular deficiencies. Intended for cementless use only.

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

• Trident® Acetabular Systems (K013676)
• Trident® Acetabular Systems (K010170)
• Implex/Zimmer's Hedrocel® Revision Cup (K001759)

Submission Summary (Full Text)

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

K0811171 (pg. 1 of 2)

# 510(k) Summary of Safety and Effectiveness

| Proprietary Name: | Tritanium®Acetabular Shell System |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Artificial Hip Replacement Components -<br>Acetabular |
| Classification Name and Reference: | Hip joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis<br>21 CFR §888.3358 |
| Proposed Regulatory Class: | Class II |
| Product Codes: | LPH - prosthesis, hip, semi-constrained,<br>metal/polymer, porous uncemented |
| For Information contact: | Kimberly Lane<br>Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone] Fax: [phone] |
| Date Prepared: | April 23, 2008 |

## Description:

The Tritanium® Acetabular Shell consists of a hemispherical acetabular shell in both solid-backed and cluster screw-hole design and is compatible with all polyethylene Trident inserts. Both shell designs will be available in sizes 44-72 mm outside diameter (OD) in 2 mm increments. The Trident shell is being modified to include a proprietary porous coating, Particle Sintered Foam. The particle sintered foam (PSF) porous metal technology offers net-shape coatings on acetabular shells from which devices can be fabricated.

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

K081171 (pg. 2 of 2)

#### Intended Use:

The Tritanium Acetabular Shell is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function.

#### Indications:

- 1. Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
- 2. Revision of previous failed femoral head replacement, shell arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive 3. techniques are less likely to achieve satisfactory results.
- 4. Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

This acetabular shell is intended for cementless use only.

## Substantial Equivalence:

The Tritanium Acetabular Shell system is substantially equivalent to other commercially available acetabular systems in regards to intended use, design, materials, and operational principles. The following devices are examples of predicate systems: Trident® Acetabular Systems (K013676 and K010170) and Implex/Zimmer's Hedrocel® Revision Cup (K001759).

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

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 stylized eagle with its wings spread, facing to the right. The eagle is rendered in black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2 2008

Howmedica Osteonics Corp. % Ms. Kimberly Lane Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430

K081171 Re: Trade/Device Name: Tritanium® Acetabular Shell System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Codc: LPH Dated: April 23, 2008 Received: April 24, 2008

Dear Ms. Lane:

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.

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.

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

Page 2 - Ms. Kimberly Lane

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, plcase contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mullison

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

### Indications for Use

510(k) Number (if known):

Device Name: Tritanium® Acetabular Shell System

Indications for Use:

The indications for use of the total hip replacement prostheses include:

- 1. Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
- 2. Revision of previous failed femoral head replacement, shell arthroplasty or other procedure.
- 3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- 4. Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

This acetabular shell is intended for cementless use only.

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| Page 1 of 1 | |
|---------------|---------|
| 510(k) Number | K081171 |

for MXM

5