TRIDENT T ACETABULAR SHELLS

K040412 · Stryker Orthopaedics · LPH · May 25, 2004 · Orthopedic

Device Facts

• Record ID: K040412
• Device Name: TRIDENT T ACETABULAR SHELLS
• Applicant: Stryker Orthopaedics
• Product Code: LPH · Orthopedic
• Decision Date: May 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trident® Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® polyethylene acetabular bearing insert. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopaedics 6.5mm or 5.5mm bone screws.

Device Story

Trident® "T" Acetabular Shells are orthopedic implants for cementless fixation in the acetabulum. Designed as hemispherical shells with thicker walls compared to predicate designs, allowing compatibility with smaller polyethylene bearing inserts. Features dome screw holes for optional 5.5mm or 6.5mm bone screws; screw holes shifted up to 4 degrees to maintain structural integrity on the inner radius. Used by orthopedic surgeons during total hip arthroplasty. The device provides a stable foundation for the hip joint, potentially improving patient mobility and reducing pain associated with degenerative joint disease. Thicker wall design provides mechanical stability comparable to or better than predicate shells, as confirmed by deflection testing.

Clinical Evidence

Bench testing only. Study compared deflection of subject devices against predicate shell designs upon implantation into the acetabulum. Results demonstrated that the thicker wall design of the subject devices exhibited less deflection than some predicate shells and approximately the same deflection as others.

Technological Characteristics

Hemispherical acetabular shell; cementless fixation; metal construction (same as predicates); features thicker walls than predicate designs; compatible with Trident® polyethylene bearing inserts; includes optional dome screw holes for 5.5mm or 5.5mm bone screws; screw hole positions shifted ≤4 degrees.

Indications for Use

Indicated for patients with painful, disabling hip joint disease (degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, late-stage avascular necrosis); revision of unsuccessful femoral head replacement, cup arthroplasty, or other procedures; clinical management where arthrodesis or alternative techniques are less likely to achieve satisfactory results; or cases where bone stock is of poor quality or inadequate for other reconstructive techniques due to acetabular deficiencies.

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® Porous Titanium (K010170)
• Trident® Porous Titanium (K013475)
• Osteonics Secur-Fit-AD Generation II Acetabular Components (K983502)
• Osteonics Generation II Acetabular Components (K983382)
• Trident® AD and AD/HA Hemispherical Acetabular Shells (K013676)

Submission Summary (Full Text)

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Trident" "T" Acctabular Shells

# MAY 2 5 2004

510(k) Premarket Notification

510(k) Summary of Safetv and Effectiveness for the TRIDENT® "T" SHELLS

K040412
page 1 of 3

Proprietary Name:

Common Name:

Classification Name and Reference

Regulatory Class:

Device Product Code:

For Information contact:

Date Summary Prepared:

February 17. 2004

## Identification of Predicates

- 1. K010170 Trident® Porous Titanium
- 2. K013475 Trident® Porous Titanium

K040412
page 1 of 3

Trident® "T" Acetabular Shells

Artificial Hip Components

Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prostheses, 21 CFR §888.3353

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis 21 CFR §888.3358

Class II

87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calciumphosphate,

87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

87 LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Ginny Stamberger Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07432 Phone: [phone] Fax: [phone] E-Mail: [e-mail]

February 17. 2004

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K040412
510(k) Premarket Notification
page 2 of 3

- 3. K983502 Osteonics Secur-Fit-AD Generation II Acetabular Components
- 4. K983382 formerly designated as Osteonics Generation II Acetabular Components
- 5. K013676 Trident® AD and AD/HA Hemispherical Acetabular Shells

## Device Description

The subject devices are identical to their corresponding predicate devices, except that they feature thicker walls. Consequently, for each shell size (except the smallest, which remains unchanged) the subject Trident® "T" Shells will be compatible with a liner one size smaller than ihat used for the predicate Trident® designs. In addition, to accommodate the thicker walls, the screw holes were mimimally shifted (not more than 4 degrees measured off the center of the shell) so as not to run into each other on the inner radius of the shell.

## Intended Use:

The Trident® "I" Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® polyethylene acetabular bearing inserts. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopaedics 6.5mm or 5.5mm bone screws.

## Indications

- · Painful, disabling joint disease of the hip resulting from: degenerative arthritis, post-oraunatic arthrits or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative rechniques are less likely to ache ve satisfactory results.
- · Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum

# Substantial Equivalence:

## Intended Use

The subject Trident® "T" Shells retain the same intended uses and same indications for use as the cited predicate Trident® Acetabular Shells.

## Materials

The subject Trident® "T" Shells are manufactured from the same materials as their corresponding predicate Trident Acetabular Shells.

## Design

The subject Trident® "T" Shells retain the same designs as their corresponding predicate Trident@ Acetabular Shells with the following exceptions: The subject devices (except for the smallest size, which was unmodified) feature thicker walls. As a consequence of the thicker

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Trident® "T" Acetabular Shells

4/04/2
510(k) Premarket Notification
page 3 of 3

5

walls, each shell now accepts an insert that is one size smaller than what is used in the corresponding predicate Trident® System Shells. To accommodate the added thickness, the screw hole locations were shifted minimally so as not to run into each other on the inner radius of the shell. No single shift was more than 4 degrees measured off the center of the shell. These design modifications do not raise new questions of safety or effectiveness.

# Testing

A study was performed to compare the deflection experienced by the subject and predicate devices. The study demonstrated that the thicker wall design of the subject and presired.
Incode for the study demonstrated that thicker wall design of the subject devices re less deflection (upon implantation into the acetabulum) than in some predicate shellis in 1) in 1 2) about the same deflection as seen in other predicate shell designs.

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Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2004

Ms. Ginny Stamberger Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07432

Re: K040412 Trade/Device Name: Trident® "T" Acetabular Shells Regulation Number: 21 CFR 888.3358, 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prothesis Regulatory Class: II Product Code: LPH, LZO, MEH Dated: April 27, 2004 Received: April 28, 2004

Dear Ms. Stamberger:

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.

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Page 2 - Ms. Ginny Stamberger

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 predicated 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" (21CFR 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 [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Mulkerson

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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Page 1 of 1

510(k) Number (if known): K0404/0

Device Name: Trident® "T" Acetabular Shells

Indications For Use:

The Trident® Acelabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® polycthylene acetabular bearing insert. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopacdics 6.5mm or 5.5mm bone screws.

Indications

- Painful, disabling joint disease of the bip resulting from: degenerative arthrins, theumatoid arthritis, post-traumatic . arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. .
- Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpari C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

l Mark N. Mulhearn

of General, Restorative, and Neurological Devices

Page 1 of

**510(k) Number** K040412