TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE

K061226 · Zimmer, Inc. · LPH · Aug 2, 2006 · Orthopedic

Device Facts

• Record ID: K061226
• Device Name: TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Aug 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for cemented use only as part of a layered construct and is indicated for patients with conditions of, but not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery, advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis, and failed previous surgery, e.g., osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty, or total hip replacement.

Device Story

Metallic, dome-shaped, flanged acetabular cage; designed to bridge acetabular bone loss/deficiencies. Features multiple screw holes for intraoperative peripheral stabilization of revision shell constructs. Available in five sizes, left/right versions, and short/long flange configurations to accommodate patient anatomy. Used by surgeons in revision hip procedures. Implanted to provide structural support and bridge bone defects; functions as part of a layered, cemented construct. Benefits patients by restoring acetabular integrity in complex revision cases.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Material: Commercially Pure (CP) Titanium. Design: Dome-shaped, flanged acetabular component with multiple screw holes. Configuration: Five sizes, left/right versions, short/long flanges. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring acetabular revision surgery due to bone loss, deficiencies, or defects (e.g., dysplasia, osteoporosis, protrusio acetabuli, cystic roof, fractures, loosening, tumors, arthritis, or failed prior hip procedures). Intended for cemented use only as part of a layered construct.

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

• Burch/Schneider™ Reinforcement Cage (K960678)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

# AUG 0 2 2006

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Jenks<br>Specialist, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | July 26, 2006 |
| Trade Name: | Zimmer Trabecular Metal™ Acetabular Revision<br>System Cage |
| Common Name: | Acetabular Cage |
| Classification Name<br>and Reference: | Prosthesis, Hip, Semi-constrained, Metal/Polymer,<br>Porous, Uncemented<br>21 CFR § 888.3358 |
| Predicate Device: | Burch/Schneider™ Reinforcement Cage, K960678,<br>cleared May 3, 1996, manufactured by Zimmer<br>GmbH (formerly Centerpulse Orthopedics Ltd.) |
| Device Description: | The Zimmer Trabecular Metal Acetabular Revision<br>System Cage is a device intended to bridge the<br>areas of acetabular bone loss in patients with<br>acetabular bone deficiencies, such as pelvic defects<br>and discontinuities. The cage is a metallic, dome-<br>shaped, flanged acetabular component with multiple<br>screw holes for adjunct intraoperative peripheral<br>stabilization of revision shell constructs.<br><br>The cage is available in five sizes configured in<br>both right and left versions along with either short<br>or long flanges to meet various anatomical needs. It<br>offers intraoperative flexibility of implant<br>orientation/positioning to accommodate patient<br>anatomies. The cage is fabricated from<br>Commercially Pure (CP) Titanium |
| Intended Use: | This device is intended for cemented use only as<br>part of a layered construct and is indicated for<br>patients with conditions of, but not limited to,<br>acetabular dysplasia, osteoporosis, protrusio<br>acetabuli, cystic acetabular roof, reconstruction in<br>cases of defects after fracture, acetabular loosening,<br>tumors or revision surgery, advanced joint<br>destruction resulting from degenerative, post-<br>traumatic, or rheumatoid arthritis, and failed<br>previous surgery, e.g., osteosynthesis, joint<br>reconstruction, arthrodesis, hemi-arthroplasty, or<br>total hip replacement. |
| Comparison to Predicate Device: | Both the predicate and proposed devices are<br>intended for revision hip surgeries to bridge the<br>areas of acetabular bone loss in patients with<br>acetabular bone deficiency. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>Engineering evaluations were performed to verify<br>that the performance of the device would be<br>adequate for anticipated in vivo use.<br>Clinical Performance and Conclusions:<br>Clinical data and conclusions were not needed for<br>this device. |

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and is composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 2 2006

Ms. Patricia Jenks Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K061226

Trade/Device Name: Trabecular Metal Acetabular Revision System Cage Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Codes: LPH Dated: July 26, 2006 Received: July 27, 2006

Dear Ms. Jenks:

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. Iisting 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 vour 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 - Ms. Patricia Jenks

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. 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Halut Lener Lwo

Mark N. Melkerson, M.S. 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):

#### Device Name:

Zimmer Trabecular Metal™ Acetabular Revision System Cage

### Indications for Use:

This device is intended for cemented use only as part of a layered construct and is indicated for patients with conditions of, but not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli. cystic acetabular roof. reconstruction in cases of defects after fracture. acetabular loosening, tumors or revision surgery, advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis, and failed previous surgery, e.g., osteosynthesis, joint reconstruction, arthrodesis. hemi-arthroplasty. or total hip replacement.

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)

Hubert Lemer

(Division Sig) :-Division of Georgi, Restorative, and Neurological Devices

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510(k) Number L061226