HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1

K022563 · Implex Corp. · MQP · Aug 30, 2002 · Orthopedic

Device Facts

• Record ID: K022563
• Device Name: HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
• Applicant: Implex Corp.
• Product Code: MQP · Orthopedic
• Decision Date: Aug 30, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.

Device Story

Hedrocel Vertebral Body Replacement (VBR) System replaces diseased/damaged vertebral bodies and adjacent discs via anterior approach. Device consists of Hedrocel Porous Tantalum deposited on vitreous carbon skeleton. Available in various cross-sections/heights with rippled superior/inferior surfaces for stability and included angles to maintain lumbar contour. Used in thoracolumbar spine (T1-L5) for tumor or trauma-related instability. Requires supplemental internal spinal fixation; compatible with bone graft. Implanted by surgeons during spinal procedures. Provides structural support to restore spinal tension and stability.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included static and dynamic compression, static and dynamic torsion, and abrasion testing to demonstrate mechanical equivalence to predicate devices. Biocompatibility data provided.

Technological Characteristics

Material: Hedrocel Porous Tantalum (tantalum on vitreous carbon skeleton). Design: Rippled superior/inferior surfaces; included angles for lumbar contour. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to collapse, damage, or instability from tumor or trauma (fracture). Must be used with supplemental internal spinal fixation; may be used with bone graft.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Hedrocel Vertebral Body Replacement (K010378)
• K021025
• K021967

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Hedrocel Vertebral Body Replacement System

| Submitter Name<br>And Address: | Implex Corp.<br>80 Commerce Drive<br>Allendale, New Jersey 07401-1600 |
|------------------------------------|-----------------------------------------------------------------------|
| Contact Person: | Marci Halevi |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | August 1, 2002 |
| Device Trade Name: | Hedrocel Vertebral Body Replacement System |
| Device Common Name: | Vertebral Body Replacement Device |
| Classification Number<br>and Name: | 21 CFR § 888.3060<br>Spinal Vertebral Body Replacement Device |

The term "substantial equivalence" as used in this 510(k) Substantial notification is limited to the definition of substantial equivalence 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 Hedrocel® Vertebral Body Replacement System is designed to Description: be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated.
The Hedrocel® Vertebral Body Replacement (VBR) System is comprised wholly of Hedrocel® Porous Tantalum (tantalum deposited on a vitreous carbon skeleton). The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine.

The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability. The Hedrocel® Vertebral Body Replacement implants have an included angle to maintain the natural contour of the lumbar spine.

The use of titanium or titanium alloy instrumentation is recommended.

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KO22563

## 510(k) Summary (Continued)

The Hedrocel® Vertebral Body Replacement System is a Indications for Use: vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., The Hedrocel® Vertebral Body Replacement is fracture). intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebrai Body Replacement may be used with bone graft.

The device is unique in comparison to predicates for this Device Technological indication with regard to its geometry. The material has been Characteristics and used in cited predicates for other applications. Comparison to Predicate Device:

The Hedrocel Vertebral Body Replacement System was tested Performance Data: per applicable standards (reference K010378). Biocompatibility data was provided to support the material's use. Performance testing was provided to support equivalent mechanical behavior to the predicates. The results demonstrated that the device will perform as intended and is equivalent to the cited predicate devices. Test data was provided regarding:

- Static compression, ●
- Dynamic compression, .
- Static torsion, .
- Dynamic torsion, and .
- Abrasion.

## Conclusion:

The Implex Hedrocel Vertebral Body Replacement System is substantially equivalent to the following predicate devices identified in this premarket notification:

| 510(k) # | Product Name | Company |
|----------|-------------------------------------|--------------|
| K010378 | Hedrocel Vertebral Body Replacement | Implex Corp. |
| K021025 | | |
| K021967 | | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 features a stylized eagle with three heads, representing the department's commitment to health, human services, and the future. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 3 0 2002

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

Re: K022563

Trade/Device Name: Hedrocel® Vertebral Body Replacement System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP Dated: August 1, 2002 Received: August 2, 2002

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.

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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 (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.

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 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ro Mark N. Milkersen

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

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Implex Corp

Hedrocel® Vertebral Body Replacement Special 510(k) Premarket Notification

51.0 (k) Number (if known) :

K022563

Device Name:

The Implex Hedrocel Vertebral Body Replacement System

Indications For Use:

The Hedrocel® Vertebral Body Replacement System is a vertebral body i replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with The Hedrocel® Vertebral Body supplemental internal spinal fixation systems. Replacement may be used with bone graft.

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Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescriptio
n Use
(Per 21 CFR 801.109)

OR...

Over-The-
Counter Use

(Optional Format 1-2-96)

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

510(k) Number K022563