THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX

K040756 · Implex Corp. · FTM · Jul 14, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040756
• Device Name: THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
• Applicant: Implex Corp.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jul 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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 Trabecular Metal Reconstruction System may also be used with bone graft.

Device Story

Trabecular Metal Reconstruction System consists of wedge-shaped components manufactured from porous tantalum; 80% porosity with 0.5mm interconnecting pores. Device provides structural reinforcement for weak or deficient bone in orthopedic procedures; wedge shapes range from 19mm to 28mm height with 5° to 30° angles. Used by orthopedic surgeons in clinical settings; implanted to support bony structures; allows for biological fixation along inner and outer segments. Ancillary fixation (plates/screws) required for long bone applications. Benefits include structural support for bone defects and potential for biological integration.

Clinical Evidence

No clinical data provided. Bench testing only; reliance on mechanical testing data from predicate devices (K02388, K962468, and MAF #920) to demonstrate performance characteristics.

Technological Characteristics

Material: Porous tantalum (Hedrocel). Structure: 80% porous with 0.5mm diameter interconnecting pores. Form factor: Wedge-shaped components, 19-28mm height, 5-30° angles. Mechanical fixation: Designed for biological fixation; requires ancillary plates/screws for long bone procedures. Non-software device.

Indications for Use

Indicated for patients requiring reinforcement of weak or deficient bony tissues during orthopedic procedures, including pelvic, acetabular, femoral, and humeral reconstruction; requires ancillary fixation for long bone procedures; may be used with bone graft.

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

• Wedge-shapes (K032344)
• K02388
• K962468

Submission Summary (Full Text)

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K046756.51 1/2

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS JUL 1 4 2004

### The Hedrocel Trabecular Metal Reconstructive System

| Submitter Name | Implex Corp. |
|------------------------------------|------------------------------------------------------|
| And Address: | 80 Commerce Drive, Allendale, New Jersey 07401-1600 |
| Contact Person: | Marci Halevi |
| Phone Number: | (201) 818 - 1800, X 507 |
| Fax Number: | (973) 829 - 0825 |
| Date Prepared: | March 19, 2004 |
| Device Trade Name: | The 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.

- Device The Trabecular Metal Reconstructive System is manufactured wholly of Description: Trabecular Metal porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. Trabecular Metal porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter.
The components of this line extension are wedge-shaped components, similar to the cleared wedge-shapes (K032344). The smallest size wedge is 19mm height with a 5° angle and the largest size wedge is 28mm height with a 30° angle. The angles run in increments of 5 degrees and there are 6 heights for each range of angles. One 'arm' is longer than the other, with the shorter 'arm' contoured along its length and slightly wider than the longer 'arm'. The base of the wedge is contoured. The relief allows biological fixation to occur along both the outer and inner segments of the device.

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# 510(K) Summary Of Safety And Effectiveness - con't

### MATERIALS: Tantalum (Hedrocel porous tantalum)

The Trabecular Metal Reconstruction System is indicated for use in Indications for Use: 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. TThe Trabecular Metal Reconstruction system may be used with bone graft.

| Device<br>Technological<br>Characteristics &<br>Comparison to<br>Predicate Device: | A comparison of device technological characteristics and properties<br>demonstrates that the device is substantial equivalent to the cited<br>predicate devices. |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Data: | The subject devices of the Trabecular Metal Reconstructive System<br>were not tested. Rather previous device testing per FDA guidance<br>documents and applicable standards were performed for the predicate<br>devices described in K02388, Master File MAF #920, and other<br>mechanical testing reported in K962468. These results indicate that the<br>subject device will perform as indicated for use in support of weakened<br>and/or deficient bony structures. |
| Conclusion: | The Trabecular Metal Reconstructive System is substantially equivalent<br>to the cited predicate devices identified in this premarket notification. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2004

Marci Halevi Manager of Regulatory Affairs Implex Corp. 80 Commerce Drive Allendale, New Jersey

Re: K040756

Trade/Device Name: Trabecular Metal Reconstruction System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM, EZX Dated: March 23, 2004 Received: March 24, 2004

Dear Ms. Halevi:

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 - Marci Halevi

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/dsma/dsmamain.html

Sincerely yours.

Mark A. Milliman

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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510(k) Number (if known) :

# 040756 -51

Device Name:

## The Trabecular Metal Reconstruction System

Indications For Use:

The 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 Trabecular Metal Reconstruction System may also be used with bone graft

Mark A. Milburn
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K040756

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR. . .

Over-The-Counter Use

(Optional Format 1-2-96)