TRIDENT CROSSFIRE POLYUETHYLENE LINERS

K021911 · Howmedica Osteonics Corp. · LPH · Jul 2, 2002 · Orthopedic

Device Facts

• Record ID: K021911
• Device Name: TRIDENT CROSSFIRE POLYUETHYLENE LINERS
• Applicant: Howmedica Osteonics Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Jul 2, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject acetabular liners are single-use devices intended for use in total hip replacement. They are intended for mechanical assembly to predicate Trident® series acetabular shells. (The predicate Trident® series shells are intended for cementless fixation.)

Device Story

Trident® Crossfire® Polyethylene Liners are acetabular components for total hip replacement; designed as a line extension to existing Trident® system. Liners are single-use; manufactured from Crossfire® polyethylene; intended for mechanical assembly into predicate Trident® cementless acetabular shells. Device provides bearing surface for femoral head in hip arthroplasty. Used in clinical/surgical settings by orthopedic surgeons. Benefits include restoration of hip function and pain relief for patients with degenerative joint disease or failed prior procedures. Safety and effectiveness demonstrated via engineering analysis of cam-out risk and hip wear simulator testing comparing new sizes to predicate liners.

Clinical Evidence

No clinical data. Evidence consists of engineering analysis to assess cam-out risk and hip wear simulator testing of a similar cup liner to demonstrate comparable safety and effectiveness to predicate devices.

Technological Characteristics

Acetabular liners manufactured from Crossfire® polyethylene. Designed for mechanical assembly into Trident® series cementless acetabular shells. Available in various sizes (26mm, 28mm, 32mm, 36mm) and configurations (0° and 10° versions). Single-use device.

Indications for Use

Indicated for patients with painful, disabling hip joint disease due to degenerative, rheumatoid, or post-traumatic arthritis, or late-stage avascular necrosis; revision of failed femoral head replacement, cup arthroplasty, or other procedures; clinical management where arthrodesis or other reconstructive techniques are less likely to succeed; or cases with poor bone stock/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

• Osteonics® Secur-FitTM AD Generation II Acetabular Component System
• Osteonics® Trident® Polyethylene Inserts
• Trident® Elevated Rim Liners

Submission Summary (Full Text)

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Kozia 11

Line Extension to the Trident® Polyethylene Acetabular System – Trident® Crossfire® Polyethylene Liners

Special 510(k) Premarket Notification

## Special 510(k) Summary

# Line Extension to the Trident® Polyethylene Acetabular System - Trident® Crossfire® Polyethylene Liners

| Proprietary Name: | Trident® Crossfire® Polyethylene Liners |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Artificial Hip Components |
| 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 |
| Device Product Code: | 87 LPH |
| Predicate Proprietary Name(s): | Osteonics® Secur-FitTM AD Generation II<br>Acetabular Component System; Line Extension<br>Osteonics® Trident® Polyethylene Inserts; and<br>Line Extension, Trident® Elevated Rim Liners |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code(s): | 87 LPH and LZO |
| For Information Contact: | Debra Bing<br>Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, New Jersey 07401-1677<br>Phone: [phone]<br>Fax: [phone] |

## Description/Technological Comparison

The existing Trident® Polyethylene Acetabular System features acetabular liners in neutral, hooded, eccentric and elevated rim versions. The subject Trident® Crossfire® Polyethylene Liners are an addition to the existing liners (standard and eccentric versions). The subject liners will be offered in fourteen new sizes which include the addition of a 36mm size eccentric liner in Page 3

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Line Extension to the Trident® Polyethylene Acetabular System -- Trident® Crossfire® Polyethylene Liners

both 0° and 10° versions and 26mm, 28mm, 32mm and 36mm size standard liners in both 0° and 10° versions in the same polyethylene thicknesses as the Trident® Elevated Rim Liners. The subject liners, like the predicate liners, are manufactured using Crossfire® polyethylene.

### Intended Use

The subject acetabular liners are single-use devices intended for use in total hip replacement. They are intended for mechanical assembly to predicate Trident® series acetabular shells. (The predicate Trident® series shells are intended for cementless fixation.)

#### Indications:

- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, theumatoid . 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 is inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.

#### Testing Summary

Engineering analysis was employed to ensure that the risk of cam-out for the subject device is less than the risk associated with predicate devices. Hip wear simulator testing of a similar cup liner was used to demonstrate the comparable safety and effectiveness of the new liner sizes in the subject series to the predicate devices.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 : :

Mr. William J. Cymbaluk Vice President Quality Assurance, Regulatory Affairs and Clinical Research Stryker Howmedica Osteonics Corporation 59 Route 17 South Allendale, NJ 07401

Re: K021911

Trade Name: Trident® Crossfire® Polyethylene Liners Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: June 7, 2002 Received: June 11, 2002

Dear Mr. Cymbaluk:

We have reviewed your Section 510(k) premarket 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) 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 (OS) 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 - Mr. William J. Cymbaluk

and the country of the first to

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

L. Colin M. Wittwer, Ph.D., M.D.

Celia M. 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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510(k) Number (if known): KO Z ( G | l

Device Name: Line Extension to the Trident® Polyethylene Acetabular System-Trident® Crossfire® Polyethylene Liners

The subject acetabular liners are single-use devices intended for use in total hip replacement. They are intended for mechanical assembly to predicate Trident® series acetabular shells. (The predicate Trident® series shells are intended for cementless fixation.)

#### Indications:

- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, theumatoid . 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 is inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Hyte Rhodes

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

510(k) Number K021911