TRIDENT LARGE DIAMETER ACETABULAR INSERTS

K062419 · Howmedica Osteonics Corp. · LPH · Nov 15, 2006 · Orthopedic

Device Facts

• Record ID: K062419
• Device Name: TRIDENT LARGE DIAMETER ACETABULAR INSERTS
• Applicant: Howmedica Osteonics Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Nov 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Trident® Large Diameter Acetabular Inserts are intended for the replacement of the bearing and articulating surfaces of the acetabulum to relieve pain, and the restriction of motion. These subject devices are provided sterile and designed for single use only, and are intended for use in patients indicated for total hip arthroplasty. The components may be used for primary and revision applications.

Device Story

Trident® Large Diameter Acetabular Inserts are Ultra High Molecular Weight polyethylene liners for hip prostheses. Available in 40mm and 44mm inner diameters to accommodate specific cobalt chrome femoral heads, with additional sizes (28-36mm) compatible with previously cleared femoral heads. Designed for use with Trident® acetabular shells in primary or revision total hip arthroplasty. Provided sterile for single-use. Orthopedic surgeons implant these devices to replace acetabular bearing surfaces, aiming to relieve pain and restore joint motion in patients with disabling hip disease or poor bone stock.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultra High Molecular Weight polyethylene acetabular inserts. Thickness ranges from 3.8mm to 12.6mm. Compatible with Trident® acetabular shells and specific cobalt chrome femoral heads. Provided sterile for single use.

Indications for Use

Indicated for patients with painful disabling hip joint disease (degenerative, rheumatoid, or post-traumatic arthritis, or late-stage avascular necrosis), patients requiring revision of unsuccessful femoral head replacement or cup arthroplasty, patients where arthrodesis or other reconstructive techniques are less likely to succeed, and patients with poor bone stock or 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® Acetabular Inserts (K033716)
• Inter-Op Durasul Acetabular System (K002575)

Reference Devices

• Howmedica Osteonics' cobalt chrome femoral heads (K061434)

Submission Summary (Full Text)

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325 Corporate Drive Mahwah, NJ USA 07430

# 510(k) Summary of Safety and Effectiveness for the Trident® Large Diameter Acetabular Inserts

NUV 15 2006

| Proprietary Name: | Trident® Large Diameter Acetabular Inserts |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Common Name: | Hip Prosthesis |
| Classification Name and Reference | Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained, Cemented or Nonporous Uncemented Prosthesis 21 CFR §888.3350 |
| | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis 21 CFR §888.3358 |
| | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis 21 CFR §888.3353 |
| Regulatory Class: | Class II |
| Device Product Code: | 87 LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented |
| | 87 LPH - Prosthesis Hip, Semi-Constrained, Porous Coated, Uncemented |
| | 87 MEH - Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum- phosphate |
| | 87 JDI - Prosthesis, hip, semi-constrained, metal/polymer, cemented |

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K062419

For Information contact:

Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07432 Phone: [phone] Fax: [phone] E-Mail: [e-mail] August 17, 2006

Date Summary Prepared:

#### Device Description

The proposed acetabular inserts are Ultra High Molecular Weight polyethylene devices that range thickness from 3.8mm to 12.6mm measured at 34° from the axis of symmetry. The subject inserts include Trident® Large Diameter acetabular inserts, which will be available in 40mm and 44mm inner diameter (ID), and accommodate Howmedica Osteonics' 40mm and 44mm cobalt chrome femoral heads (K061434). The sizes 28 through 36 inner diameter inserts accommodate previously cleared Howmedica Osteonics' femoral heads. The polyethylene liners are compatible with the Trident® line of acetabular shells.

## Intended Use:

The Trident® Large Diameter Acetabular Inserts are intended for the replacement of the bearing and articulating surfaces of the acetabulum to relieve pain, and the restriction of motion.

These subject devices are provided sterile and designed for single use only, and are intended for use in patients indicated for total hip arthroplasty. The components may be used for primary and revision applications.

## Indications for Use

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

## Substantial Equivalence:

The Trident® large diameter acetabular inserts are substantially equivalent to Howmedica Osteonics' Trident® Acetabular Inserts, K033716 and Inter-Op Durasul Acetabulan System cleared by Sulzer Orthopaedics, K002575.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corp. % Ms. Tiffani Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

NOV 15 2006

Re: K062419

Trade/Device Name: Trident® Large Diameter Acetabular Inserts Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Codes: LPH, JDI, LZO, MEH Dated: August 17, 2006 Received: August 18, 2006

Dear Ms. Rogers:

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. Tiffani Rogers

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" (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/industry/support/index.html.

Sincerely yours,

for Rob

Mark N. Melkerson
Director

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): 1662419

Device Name: Trident® Large Diameter Acetabular Inserts

#### Indications for Use

- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid 매 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 reconstructive techniques are 피 less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as 트 indicated by deficiencies in the acetabulum.

Prescription Use

OR Over-the-Counter Use -------(Per 21 CFR 801.109)

Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

P.O. Runa

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

11962919 510(k) Number