ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM

K093561 · Zimmer, Inc. · LPH · Apr 28, 2010 · Orthopedic

Device Facts

• Record ID: K093561
• Device Name: ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Apr 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trabecular Metal Modular Acetabular System with a Trilogy Neutral, Elevated, Offset or Oblique Liner 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. The Trabecular Metal Modular Acetabular System with a Trilogy Longevity® Constrained Liner is indicated for primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained components have been considered. This device is intended for either cemented or noncemented use.

Device Story

Modular acetabular cup system for hip joint replacement; replaces damaged hip joint via biological fixation (uncemented) or bone cement. System comprises Tivanium (Ti-6Al-4V alloy) shell with metallurgically bonded Trabecular Metal porous coating and polyethylene liner. Shells available in 38-80mm diameters; options include multiple screw holes, cluster screw holes, or no screw holes for Tivanium alloy screw fixation. Used by orthopedic surgeons in clinical/surgical settings. Provides stable acetabular component for hip arthroplasty; facilitates bone ingrowth for long-term fixation; restores joint function; reduces dislocation risk when using constrained liners.

Clinical Evidence

No clinical data. Substantial equivalence based on non-clinical performance testing, including evaluation of device design and geometry per FDA Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement (4/28/94).

Technological Characteristics

Modular acetabular shell; Tivanium (Ti-6Al-4V alloy) substrate; Trabecular Metal porous coating; polyethylene liner. Diameter range 38-80mm. Fixation via biological ingrowth (porous) or bone cement. Screw fixation option using Ti-6Al-4V alloy screws. Threaded polar hole for cup positioner attachment.

Indications for Use

Indicated for primary or revision total hip arthroplasty in patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, diastrophic variant). Constrained liner indicated for patients at high risk of dislocation due to instability, bone loss, or tissue laxity where other options considered.

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

• Zimmer Trabecular Metal Modular Acetabular System (K021891)
• Trilogy Longevity Constrained Liner (K071718)

Submission Summary (Full Text)

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K093561

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

APR 2 8 2010

# Summary of Safety and Effectiveness

| Sponsor: | Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Benjamin C. Curson, RAC Associate Project Manager, Regulatory Affairs Telephone: [phone] Fax: [phone] |
| Date: | April 26, 2010 |

Zimmer Trabecular Metal™ Modular Acetabular System

LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented.

JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented

KWZ - Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer

Image /page/0/Picture/11 description: The image shows a logo with the letter 'Z' inside a circle, above the word 'zimmer' in lowercase letters. The 'Z' is bold and stylized, filling most of the circle. The word 'zimmer' is in a bold, sans-serif font and is positioned directly below the circle containing the 'Z'. The overall design is simple and modern, with a focus on the letter 'Z' and the company name.

Trade Name:

Product Code / Device:

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April 26, 2010

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| Regulation Number / Description: | 21 CFR § 888.3358 - Hip joint<br>metal/polymer/metal semi-constrained porous-<br>coated uncemented prosthesis. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 21 CFR § 888.3350 - Hip joint metal/polymer<br>semi-constrained cemented prosthesis |
| | 21 CFR § 888.3353 - Hip joint<br>metal/ceramic/polymer semi-constrained cemented<br>or nonporous uncemented prosthesis |
| | 21 CFR § 888.3310 - Hip joint metal/polymer<br>constrained cemented or uncemented prosthesis |
| Predicate Device: | Zimmer Trabecular MetalTM Modular Acetabular<br>System, manufactured by Zimmer, Inc. K021891,<br>cleared September 05, 2002. |
| | Trilogy® Longevity® Constrained Liner,<br>manufactured by Zimmer, Inx. K071718, cleared<br>July 13, 2007. |
| 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>biological fixation to bone without the use of bone<br>cement; or, it may also be for cemented fixation.<br>The system consists of a shell and polyethylene<br>liner. The shell substrate is made from TivaniumTM<br>Ti-6Al-4V Alloy. The outer porous material, which<br>is metallurgically bonded to the shell substrate, is<br>made of Trabecular Metal. |
| | Three porous acetabular shell designs are available:<br>one with multiple screw holes, one with cluster<br>screw holes and one without screw holes. The<br>shells range in diameter from 38 to 80mm in 2mm<br>increments. The screw holes permit the use of<br>Tivanium Ti-6Al-4V Alloy screws for immediate<br>fixation and security. The shell incorporates a<br>threaded polar hole to attach the cup positioner. |

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Page 3 April 26, 2010

Intended Use:

The Trabecular Metal Modular Acetabular System with a Trilogy Neutral, Elevated, Offset or Oblique Liner 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.

The Trabecular Metal Modular Acetabular System with a Trilogy Longevity® Constrained Liner is indicated for primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained components have been considered.

This device is intended for either cemented or noncemented use.

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

Non-Clinical Performance and Conclusions:

Non-clinical testing was provided, including the information outlined in the FDA" Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, 4/28/94;" and, an evaluation of the device design and geometry that demonstrated that the Zimmer Trabecular Metal Modular Acetabular System met performance requirements and is as safe and effective as its predicate and this information and testing data formed the basis for a determination of substantial equivalence.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

# APR 2 8 2010

Zimmer. Inc. % Mr. Benjamin C. Curson, RAC Associate Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K093561

Trade/Device Name: Zimmer Trabecular Metal Modular Acetabular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, JDI, LZO, KWZ Dated: April 26, 2010 Received: April 27, 2010

Dear Mr. Curson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Benjamin C. Curson, RAC

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Qubau hum

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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<093541

# Indications for Use

## 510(k) Number (if known):

### Device Name:

Zimmer Trabecular Metal™ Modular Acetabular System

#### Indications for Use:

The Trabecular Metal Modular System when used with a Trilogy® Neutral, Elevated, Offset or Oblique Liner 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.

The Trabecular Metal Modular System when used with a Trilogy Longevity® Constrained Liner is indicated for primary or revision total hip arthorplasties where is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.

This device is intended for either cemented or noncemented use.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Senuta for mxn

(DKision Sign-Ord Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093561

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