TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES

K021826 · Zimmer, Inc. · KWZ · Dec 20, 2002 · Orthopedic

Device Facts

• Record ID: K021826
• Device Name: TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES
• Applicant: Zimmer, Inc.
• Product Code: KWZ · Orthopedic
• Decision Date: Dec 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trilogy Constrained Liner is indicated for either cemented or noncemented use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

Device Story

Trilogy Constrained Liner is a two-piece acetabular liner assembly consisting of a UHMWPE liner and a Tivanium (Ti-6Al-4V) constraining ring. Used with Trilogy Acetabular System metal shells in total hip arthroplasty. Features 10-degree oblique face to reduce soft tissue laxity and increase length; face can be rotated to reposition coverage against anticipated instability. Assembled by surgeon intraoperatively. Provides mechanical constraint to prevent hip dislocation in high-risk patients.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, specifically static assembly and lever-out evaluations.

Technological Characteristics

Materials: UHMWPE liner, Tivanium (Ti-6Al-4V) alloy constraining ring. Form factor: 32mm internal diameter, 50-80mm outer diameter. Design: 10-degree oblique face for offset/eccentricity. Mechanical assembly by surgeon.

Indications for Use

Indicated for primary or revision total hip arthroplasty patients at high risk of dislocation due to prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability, where other constrained options have been considered.

Regulatory Classification

Identification

A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”

Predicate Devices

• Johnson & Johnson POLY-DIAL Constrained Acetabular Liner for the S-ROM -Total Hip System (P960054)

Submission Summary (Full Text)

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K021826

Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle is the word "zimmer" in a smaller, sans-serif font.

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P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

Summary of Safety and Effectiveness

## Submitted By:

DEC 2 0 2002

.

Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 574-267-6131

### Contact Person:

Karen Cain Manager, Regulatory Affairs Telephone: [phone] FAX: [phone]

### Date:

October 1, 2002

### Trade Name:

Trilogy® Acetabular System Constrained Liner

# Common Name:

Constrained Acetabular Liner

# Classification Name:

Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis

# Predicate Devices:

- Johnson & Johnson POLY-DIAL Constrained Acetabular Liner for the S-ROM -Total Hip System, P960054, approved June 19, 1997

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### Description:

The Trilogy Constrained Liner is a polyethylene liner assembly used in conjunction with a Trilogy Acetabular System metal shell in total hip arthroplasty procedures. The liner consists of two pieces: a liner and a constraining ring. The liner is manufactured from ultra-high molecular-weight polyethylene (UHMWPE) and the constraining ring is manufactured from Tivanium® Ti-6A1-4V Alloy.

The Trilogy Constrained Liner is offered with a 32mm internal diameter and 50-80mm outer diameter sizes. The inner diameter and face of the liner is oblique by 10 degrees resulting in offset and slight eccentricity between the internal and external diameter centers. This resultant offset acts to reduce soft tissue laxity and increase length which can contribute to joint instability. The 10-degree face can be rotated to reposition coverage opposite the direction of anticipated instability.

#### Intended Use/Indications for Use

The Trilogy Constrained Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

#### Comparison to Predicate Devices

The acetabular cup listed above is substantially equivalent to the Trilogy Constrained Liner in that both are intended to replace the bearing surface of the acetabulum in patients at high risk of dislocation. The predicate device, as well as the Trilogy Constrained Liner, is manufactured from UHMWPE and features a constraining ring made of titanium alloy which is assembled by the surgeon at the time of surgery. Static assembly and lever-out evaluations indicated that this device would perform as intended and similar to other legally marketed devices.

RA092500K.LT

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, representing health and well-being.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Cain Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 .

#### Re: K021826

Trade/Device Name: Trilogy® Acetabular System Constrained Liner Regulation Number: 21 CFR 888.3310 1 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: October 1, 2002 Received: October 3, 2002

Dear Ms. Cain:

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 (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 - Ms. Karen Cain

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]. 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,

Muriam C. Provost

fo 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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Exhibit K

Page 1 of 1

510(k) Number (if known

02182

Device Name:

Trilogy® Acetabular System Constrained Liner

#### Indications for Use:

The Trilogy Constrained Liner is indicated for either cemented or noncemented use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

RA06201K.510

íriam C. Provost

sion of General, Restorative d Neurological Devices

Ko21826