TRIDENT ACETABULAR SYSTEM

K033716 · Howmedica Osteonics Corp. · LPH · Feb 10, 2005 · Orthopedic

Device Facts

• Record ID: K033716
• Device Name: TRIDENT ACETABULAR SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Trident® Acetabular Hip System Polyethylene inserts are intended for use with the mating Trident Acetabular Shells. The Trident Acetabular Shells are intended for cementless fixation. The Trident® Hip System components are for use in total hip arthroplasty to relieve pain and restore function for indications such as: painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis; revision of previous failed femoral head replacement, cup arthroplasty or other procedure; clinical management problems where arthrodesis or alternative reconstructive 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.

Device Story

Trident® Hip System acetabular inserts replace bearing surfaces in total hip arthroplasty; relieves pain and restores function. Modification involves sequentially crosslinked and annealed polyethylene material sterilized via STERRAD gas plasma. Components mate with Trident® Acetabular Shells for cementless fixation. Used in clinical settings by orthopedic surgeons. Output is a mechanical bearing surface; clinical decision-making relies on surgeon assessment of joint disease and bone stock. Benefits include improved wear characteristics and stability for patients with degenerative bone disease, trauma, or failed prior implants.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included material properties, wear testing, sterilization effects, dimensional assessment, disassembly force evaluation, and contact stress analysis.

Technological Characteristics

Acetabular inserts for total hip arthroplasty. Material: Sequentially crosslinked and annealed polyethylene. Sterilization: STERRAD gas plasma. Design: Semi-constrained, porous-coated uncemented prosthesis. Connectivity: None (mechanical implant).

Indications for Use

Indicated for patients requiring total hip arthroplasty due to painful, disabling joint disease (non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, late stage avascular necrosis), revision of failed previous procedures, or clinical management problems where alternative reconstructive techniques are less likely to succeed due to 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® Hip System (K033716)

Submission Summary (Full Text)

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K033716 FEB 1 0 2005

## Summary of Safety and Effectiveness

| Contact Person: | Karen Ariemma<br>Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>[phone] (Phone)<br>[phone] (FAX) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 3, 2005 |
| Device: | Trident® Hip System |
| Classification: | Prosthesis Hip, Semi-Constrained, Porous Coated,<br>Uncemented Prosthesis: 21 CFR 888.3358 |
| | Hip Joint Metal/Ceramic/Polymer Semi-constrained<br>cemented or nonporous uncemented prosthesis: 21 CFR<br>888.3353 |
| | Hip Joint Metal/Polymer Semi-Constrained Cemented<br>Prosthesis, 21 CFR 888.3350 |
| Device Product Codes: | 87 JDI, 87 LPH, 87 LWJ, 87 LZO, 87 MEH: |
| Predicate Devices: | Trident® Hip System |
| Indications for Use: | The Trident® Acetabular Hip System Polyethylene inserts<br>are intended for use with the mating Trident Acetabular<br>Shells. The Trident Acetabular Shells are intended for<br>cementless fixation. The Trident® Hip System components<br>are for use in total hip arthroplasty to relieve pain and<br>restore function for indications such as: painful, disabling<br>joint disease of the hip resulting from: non-inflammatory<br>degenerative arthritis, rheumatoid arthritis, post-traumatic<br>arthritis, or late stage avascular necrosis; revision of<br>previous failed femoral head replacement, cup arthroplasty<br>or other procedure; clinical management problems where<br>arthrodesis or alternative reconstructive techniques are less<br>likely to achieve satisfactory results, where bone stock is of<br>poor quality or inadequate for other reconstructive<br>techniques as indicated by deficiencies of the acetabulum. |

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| Proposed Modification: | Addition of new polyethylene components of a modified<br>sequentially crosslinked and annealed material which has<br>undergone a STERRAD gas plasma sterilization. |
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| Device Description: | The device includes the acetabular inserts of a total hip<br>system. These components are used for the replacement of<br>the bearing surface of the acetabulum to relieve pain,<br>instability and the restriction of motion due to degenerative<br>bone disease, including osteoarthritis, rheumatoid arthritis,<br>failure of other devices or trauma. |
| Summary of Data: | A risk analysis and research and development testing have<br>been performed to demonstrate equivalence of the proposed<br>products to the predicate devices. The testing includes<br>material properties testing; wear testing; the effect of<br>sterilization on the sequentially crosslinked and annealed<br>material; dimensional assessment of the sequentially<br>crosslinked and annealed material; disassembly force<br>evaluation; and contact stresses. |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2005

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K033716

Trade/Device Name: Trident® Hip System Trade/Device Name: "Thuene" Thp 3558:21 CFR 888.3353 and 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Hip joint metal/ceramic/polymer semiancetrained cemented or nonporous uncemented prosthesis,Hip joint metal/polymer semi-constrained cemented prosthesis

Regulatory Class: II Product Code: LPH, LZO, JDI, MEH and LWJ Dated: December 14, 2004 Received: December 15, 2004

Dear Ms. Ariemma:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed four becalent of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreases in the enactment date of the Medical Device Amendments, or to commerce prior to rias 2011-12-11 in accordance with the provisions of the Federal Food, Drug, devices mark nave occh recident a newee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general voltrols pro reserving 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 If your device is olassinod (600 a00 10) als. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i least of advised that i Dr brisean that your device complies with other requirements of the Act that I Dri has intace a and regulations administered by other Federal agencies. You must

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## Page 2 - Ms. Karen Ariemma

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 CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This icter with anow you to ough mailing of substantial equivalence of your device to a legally premarket notification. The FDA mianing of castion 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 11 you desire specific advice for Jour do 100-276-0120. Also, please note the regulation entitled, Connact the Office of Collier of Colliention" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours

Martin M. Wilkerson

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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## Indications for Use

510(k) Number (if known): K033716

## Device Name: Trident Hip System - Polyethylene Inserts

Indications For Use:

The Trident® Acetabular Hip System Polyethylene inserts are intended for use with the mating Trident® Acetabular Shells. The Trident® Acetabular Shells are intended for cementless fixation. The Trident® Acetabular Hip System Polyethylene inserts are indicated for use in total hip arthroplasty in the following instances:

- Painful, disabling joint disease of the hip resulting from: non-inflammatory . degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
- Revision of previous failed femoral head replacement, cup arthroplasty or other . procedure.
- Clinical management problems where arthrodesis or alternative reconstructive � 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

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 IF NEEDED)

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Concurrence of CDRH Office of Device Evaluation (ODE)
*Met*
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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510(k) Number K033716