CERMET III ACETABULAR CUP SYSTEM

K071583 · Implants International, Ltd. · MEH · Jul 25, 2007 · Orthopedic

Device Facts

• Record ID: K071583
• Device Name: CERMET III ACETABULAR CUP SYSTEM
• Applicant: Implants International, Ltd.
• Product Code: MEH · Orthopedic
• Decision Date: Jul 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CER-MET™ III Acetabular Cup System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.

Device Story

CER-MET™ III Acetabular Cup System is a non-cemented orthopedic implant for hip replacement or revision. System includes acetabular shell, neutral or 10° hooded poly inserts, acetabular screws, and screw hole occluders. Device is implanted by orthopedic surgeons in a clinical/surgical setting to replace damaged hip joint surfaces. Implant provides structural support and articulation for the hip joint, aiming to restore function and reduce pain associated with arthrosis or previous surgical failure. Biomechanical testing confirms suitability for in vivo loading.

Clinical Evidence

Bench testing only. Biomechanical tests were performed to evaluate the device's structural integrity and performance under loading conditions. Results were found to be equivalent to similar legally marketed implants.

Technological Characteristics

Non-cemented acetabular cup system. Components include acetabular shell, poly inserts (neutral and 10° hooded), acetabular screws, and screw hole occluders. Designed for uncemented fixation. No software or electronic components.

Indications for Use

Indicated for patients requiring uncemented hip arthroplasty due to arthrosis (degenerative, post-traumatic, or rheumatoid arthritis), femoral head fracture, avascular necrosis, or sequelae of prior hip surgeries (e.g., internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty, or total hip replacement). Also indicated for acetabular revisions.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Trident® 'T' Acetabular Shells (K040412)

Submission Summary (Full Text)

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KU71583

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| Contact: | Mr. Mohan Emmanuel, President<br>Implants International, Ltd..<br>71 Jay Avenue<br>Teeside Industrial Est.<br>Thornaby-On-Tees<br>United Kingdom T517 9LZ<br>Telephone: [phone]<br>Email: [e-mail] | JUL 25 2007 | | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|--|
| Trade name: | CER-MET™ III Acetabular Cup System | | | |
| Common name: | Acetabular Cup | | | |
| Classification<br>name: | Hip joint metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis | | | |
| | Hip joint metal/polymer/ceramic/polymer semi-constrained cemented<br>or nonporous uncemented prosthesis | | | |
| Regulation<br>number: | 21 CFR 888.3358 - Class II, Orthopedic Device Panel 87 | | | |
| | 21 CFR 888.3353 - Class II, Orthopedic Device Panel 87 | | | |
| Product Code: | MEH, LWJ, LZO, LPH | | | |
| Device<br>Description and<br>Characteristics: | The CER-MET™ III Acetabular Cup System is a non-cemented<br>acetabular cup system with a complete assortment of neutral and 10°<br>hooded poly inserts as well as acetabular screws and screw hole<br>covers (screw hole occluders). | | | |
| Equivalence: | The CER-MET™ III Acetabular Cup System is equivalent to other<br>legally marketed acetabular cup systems in design, materials and<br>intended use. Equivalent devices include the: | | | |
| | Trident® "T' Acetabular Shells marketed by Stryker Orthopaedics<br>(K040412 - S/E May 25, 2004) | | | |
| Indications: | The CER-MET™ III Acetabular Cup System is intended for<br>uncemented use for all types of arthrosis, such as advanced<br>destruction of the hip joint due to degenerative, post-traumatic or<br>rheumatoid arthritis, fracture or avascular necrosis of the femoral<br>head, sequelae of previous operations, such as internal fixation, joint<br>reconstruction, arthrodesis, hemiarthroplasty or total hip replacement.<br>The same considerations apply to acetabular revisions. | | | |
| Performance<br>data: | Biomechanical tests have been performed. The test results were<br>equivalent to other similar implants and are sufficient for in vivo<br>loading. | | | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Implants International % Turnkey Intergration, Inc. Mr. Carl Knobloch 5349 Red Leaf Court Ovieda, FL 32765

JUL 25 2007

Re: K071583 Trade/Device Name: CER-MET® III Acetabular Cup System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: MEH, LWJ, LZO, LPH Dated: April 16, 2007 Received: June 8, 2007

Dear Mr. Knobloch:

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 (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. Carl Knobloch

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

Mark N. Melkerson 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:

Device Name(s):

CER-MET™ III Acetabular Cup System

Indications for Use:

The CER-MET™ III Acetabular Cup System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.

Prescription Use X

AND/OR

Over-The-Counter-Use

(21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Karlene Bowen

Division of G Restorative. and Neurological Devices

510(k) Number K07158

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