ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM

K021891 · Zimmer, Inc. · LPH · Sep 5, 2002 · Orthopedic

Device Facts

• Record ID: K021891
• Device Name: ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Sep 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. This device is intended for either cemented or noncemented use.

Device Story

Modular acetabular cup system for total hip arthroplasty; replaces damaged hip joint. System comprises Tivanium (Ti-6Al-4V) shell substrate with metallurgically bonded Trabecular Metal porous outer layer. Available in diameters 38-80mm; options include screw holes (standard or cluster) or no screw holes. Tivanium screws (4.5mm/6.5mm) provide fixation. Designed for cemented or noncemented implantation. Used by orthopedic surgeons in clinical/OR settings. Provides stable acetabular component for hip reconstruction; facilitates bone fixation; restores joint function.

Clinical Evidence

No clinical data. Bench testing only; Trabecular Metal/Tivanium alloy interface tested per FDA guidance and ASTM standards to confirm integrity under physiological loads.

Technological Characteristics

Materials: Tivanium (Ti-6Al-4V) alloy shell, Trabecular Metal porous coating. Modular design; hemispherical inner diameter, elliptical outer diameter. Fixation: Cemented or noncemented. Accessories: Tivanium screws (4.5mm, 6.5mm). Dimensions: 38-80mm diameter (2mm increments).

Indications for Use

Indicated for primary or revision hip surgery in patients with noninflammatory degenerative joint disease (NIDJD), including osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, and diastrophic variant.

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

• Trilogy Acetabular System (K934765)
• Implex Hedrocel Modular Elliptical Acetabular Cup (K001039)

Submission Summary (Full Text)

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## 5 2002 SEP

## Summary of Safety and Effectiveness

K021891
page 1 of 2

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fred McClure<br>Senior Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | June 6, 2002 |
| Trade Name: | Zimmer Trabecular Metal Modular Acetabular<br>System |
| Common Name: | Acetabular component for total Hip prosthesis |
| Classification Name<br>and Reference: | Hip joint metal/polymer semi-constrained cemented<br>prosthesis; 21 CFR § 888.3350<br>Hip joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis;<br>21 CFR § 888.3358 |
| Predicate Device: | <i>Trilogy</i> ^® Acetabular System, manufactured by<br>Zimmer, Inc., (K934765), cleared April 29, 1994;<br>and Implex Hedrocel Modular Elliptical Acetabular<br>Cup, manufactured by Implex Corp., (K001039),<br>cleared June 15, 2000. |
| Device Description: | The Zimmer Trabecular Metal Modular Acetabular<br>System is a modular acetabular cup system intended<br>to replace a hip joint and designed to achieve<br>fixation to bone either with or without the use of<br>bone cement. The system consists of a shell and<br>liner. The shell substrate is made from <i>Tivanium</i> ^®<br>Ti-6Al-4V Alloy. The outer porous material, which<br>is metallurgically bonded to the shell substrate, is<br>made of Trabecular Metal. The Trabecular Metal<br>material has an elliptical outer diameter and a<br>hemispherical inner diameter to allow hemisphere<br>to hemisphere bonding between the Trabecular<br>Metal and the <i>Tivanium</i> substrate. |

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Intended Use:

Comparison to Predicate Device:

Performance Data (Nonclinical

and/or Clinical):

Kcd1891
page 2 of 2

Three porous acetabular shell designs are available: one with screw holes, one with cluster screw holes and one without screw holes. The shells range in diameter from 38 to 80 mm in 2mm increments. The screw holes permit the use of Tivanium Allov screws to provide immediate fixation and security. Screws are available in 4.5 and 6.5mm diameters with varying lengths. The shell incorporates a threaded polar hole to attach the cup positioner.

This device is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. This device is intended for either cemented or

noncemented use.

The Zimmer Trabecular Metal Modular Acetabular System incorporates the same materials, has the same intended use, and similar technological and geometrical features as the legally marketed predicate devices.

Non-Clinical Performance and Conclusions:

The Trabecular Metal/Tivanium alloy interface was tested per applicable FDA Guidance Documents and ASTM Standards and the results demonstrated that the interface will maintain its integrity under physiological loads.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

0016

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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 an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 2002 SEP

Mr. Fred McClure Senior Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw. IN 46581-0708

Re: K021891

Trade Name: Zimmer Trabecular Metal Modualr Acetabular System Regulation Number: 21 CFR 888.3350 and 888.3358 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II

Product Code: JDI and LPH Dated: June 6, 2002 Received: June 7, 2002

Dear Mr. McClure:

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 (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 – Mr. Fred McClure

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.

Stept Rlwdw

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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## Indications for Use

Page 1 of 1

KO21891 510(k) Number (if known):

Device Name:

Zimmer® Trabecular Metal Modular Acetabular System

Indications for Use:

This device is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.

This device is intended for either cemented or noncemented use.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices

| 510(k) Number | K 021891 |
|---------------|----------|
|---------------|----------|

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