THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ

K033384 · Implex Corp. · JDK · Nov 19, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033384
• Device Name: THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
• Applicant: Implex Corp.
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Nov 19, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel Trabecular Metal Reconstruction System may also be used with bone graft.

Device Story

Hedrocel Trabecular Metal Reconstruction System; porous tantalum surgical mesh; 80% porosity with 0.5mm interconnecting pores. Used by surgeons in orthopaedic procedures to reinforce weak/deficient bone; requires ancillary fixation (plates/screws) for long bone applications; compatible with bone graft. Provides structural support to bony tissues. Not for spinal use.

Clinical Evidence

Bench testing only. Mechanical test data and calculations referenced from MAF #920 and K962468 demonstrate sufficient strength for the indicated use in supporting weakened or deficient bony structures.

Technological Characteristics

Material: Hedrocel porous tantalum. Structure: 80% porous with ~0.5mm diameter interconnecting pores. Form factor: Surgical mesh components. Energy source: None (passive implant). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring reinforcement of weak or deficient bony tissues during orthopaedic procedures, including pelvic, acetabular, femoral, and humeral reconstruction; cement restriction; and use with bone graft. Contraindicated for spinal applications.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• K010378
• K023882
• K032282
• K032344

Reference Devices

• MAF #920
• K962468

Submission Summary (Full Text)

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NOV 1 9 2003

#### 1 . 42 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## The Hedrocel Trabecular Metal Reconstructive System

| Submitter Name | Implex Corp. |
|------------------------------------|-------------------------------------------------------|
| And Address: | 80 Commerce Drive<br>Allendale, New Jersey 07401-1600 |
| Contact Person: | Marci Halevi |
| Phone Number: | (201) 818 - 1800, ext. 507 |
| Fax Number: | (973) 829 - 0825 |
| Date Prepared: | October 21, 2003 |
| Device Trade Name: | The Hedrocel Trabecular Metal Reconstructive System |
| Device Common Name: | Surgical Mesh |
| Classification Number<br>and Name: | 21 CFR § 878.3300<br>Surgical Mesh |

Substantial The term "substantial equivalence" as used in this 510(k) Equivalence: notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

Metal Device Hedrocel Trabecular Reconstruction Svstem The ાંટ Description: manufactured wholly of Hedrocel porous tantalum. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. This line extension adds new components to the Hedrocel Trabecular Metal Reconstruction System.

MATERIALS: Tantalum (Hedrocel porous tantalum)

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### 510(k) Summary Continued ...

Indications for The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic Use: surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel Trabecular Metal Reconstruction System may also be used with bone graft.

Device

Technological Characteristics & Comparison to Predicate Device: A comparison of device technological characteristics and properties demonstrates that the device is substantial equivalent to the cited predicate devices.

Performance The Hedrocel Trabecular Mefal Reconstructive System was tested per FDA quidance documents and applicable standards for K010378, as Data: referenced in the predicate K023882, K032282 and K032344. In addition, mechanical test data found in MAF #920 and K962468, and calculations found herein indicate the subject Hedrocel porous tantalum devices possess sufficient strength for the indicated use. These results indicate that the subject device will perform as indicated for use in support of weakened and/or deficient bony structures.

- Conclusion: The Hedrocel Trabecular Metal Reconstructive System is substantially equivalent to the cited predicate devices identified in this premarket notification.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2003

Ms. Marci Halevi Manager of Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600

> K033384 Device Name: Hedrocel Trabecular Metal Reconstruction System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: October 21, 2003 Received: October 23, 2003

Dear Ms. Halevi:

Re:

We have reviewed your Section 510(k) pre-market 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 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:

THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. WARNING:

# THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

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 vour 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.

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Page 2 - Ms. Marci Halevi

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.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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,

Daniel Schultz, M.D.

Daniel Schultz, N M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Implex Corp.

1033384

Hedrocel Trabecular Metal Reconstruction System Special 510(k) Premarket Notification

510(k) Number (if known) :

K03384

Device Name:

# The Hedrocel Trabecular Metal Reconstruction System

Indications For Use :

The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel Trabecular Metal Reconstruction System may also be used with bone graft.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescripti
on Use
(Per 21 CFR 801.109)

OR . . .

Over - The -Counter Use

(Optional Format 1-2-96)