OBELISC VERTEBRAL BODY REPLACEMENT DEVICE

K060416 · Ulrich GmbH & Co. KG · MQP · Dec 26, 2006 · Orthopedic

Device Facts

• Record ID: K060416
• Device Name: OBELISC VERTEBRAL BODY REPLACEMENT DEVICE
• Applicant: Ulrich GmbH & Co. KG
• Product Code: MQP · Orthopedic
• Decision Date: Dec 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vertebral body replacement intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The obelisc™ Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of bone grafting material with the obelisc™ Vertebral Body Replacement is optional.

Device Story

The obelisc™ Vertebral Body Replacement is a mechanical implant used in open thoracolumbar spine surgery to replace collapsed or unstable vertebral bodies. The device consists of a center piece and various straight or angled end pieces, allowing for distraction heights between 20 and 132 mm. Surgeons operate the device via a bevel gear drive unit to achieve precise in-situ height adjustment, which is then secured using a locking screw. Spikes on the end pieces provide anchoring to vertebral end plates. The device is designed to be used in conjunction with supplemental internal spinal fixation systems (e.g., pedicle screws, rods, or plates). Bone graft material may optionally be placed around the implant to promote fusion. The device restores vertebral column height and stability, benefiting patients suffering from spinal trauma or tumors.

Clinical Evidence

Bench testing only. Mechanical testing was performed in accordance with ASTM F 2077-00 (Test Methods for Intervertebral Body Fusion Devices). No clinical data provided.

Technological Characteristics

Materials: Titanium alloy (ISO 5832-3:2000, ASTM F-136-02a). Principle: Mechanical distraction via bevel gear drive unit with locking screw. Dimensions: 20-132 mm distraction height; 20-30 mm diameter. Form factor: Modular center and end pieces. Energy source: Manual (mechanical).

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to collapse, damage, or instability caused by tumor or trauma (e.g., fracture). Must be used with supplemental internal spinal fixation.

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

• XPAND Corpectomy Spacer (K050850)
• VBR™ Vertebral Body Replacement Device (K012254)

Submission Summary (Full Text)

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K060416
Page 1 of 3

# Section 5 - 510(k) Summary

### Submitter Information

Contact Christoph Ulrich Marketing Director Spinal Systems Management Representative for Quality Systems ulrich GmbH & Co. KG Buchbrunnenweg 12 89081 Ulm Germany

Telefon/Phone: [phone] [phone] Telefax/Fax: e-mail: [e-mail] internet: http://www.ulrichmedical.com

Date Prepared October 31, 2006

Product Name obelisc™ Vertebral Body Replacement

Predicate Device

This device is substantially equivalent to the following legally marketed devices:

| 510(k) Reference | Description | Submitted By |
|------------------|-------------------------------------------|----------------------|
| K050850 | XPAND Corpectomy<br>Spacer | Globus Medical, Inc. |
| K012254 | VBR™ Vertebral Body<br>Replacement Device | Osteotech, Inc. |

### Product Description

The obelise TM Vertebral Body Replacement device is used for the bridging of substance defects in the anterior human thoracic and lumbar spine.

The defect is bridged by distraction of the implant and the vertebral column is straightened. Via a bevel gear drive unit, the necessary height of the implant can be adjusted exactly and fixed in situ. The height can be adjusted via a bevel gear drive unit, with pins to prevent overdistraction. The adjusted height is fixed in position by means of a locking screw. Spikes at the end pieces improve the anchoring of the implant on the end plates of the vertebral bodies.

DEC 26 2006

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Bone graft material can be placed around the obelise™ Vertebral Body Replacement as needed.

The obelisc ™ Vertebral Body Replacement consists of a center piece and two corresponding straight or angled end pieces. The standard diameter of the center pieces is 20 mm. One end has already been produced with a 0° end piece with Ø 20 mm. The end pieces are available in three diameters (20 mm, 26 mm) and with different angles (0°, 5°, 10°). One oval end piece (26 x 30 mm) with an angle of 15° is available. The center piece defines the minimum and maximum expansion height. The distraction heights range from 20 to 132 mm.

| Implants | Height | Product number |
|----------------------------------------|-------------|----------------|
| obeliscTM center piece, Ø 20 mm | 20 - 28 mm | CS 2920-20 |
| | 25 - 37 mm | CS 2920-25 |
| | 32 - 47 mm | CS 2920-32 |
| | 40 - 62 mm | CS 2920-40 |
| | 53 - 87 mm | CS 2920-53 |
| | 76 - 132 mm | CS 2920-76 |
| obeliscTM end piece, Ø 20 mm | 0° | CS 2921-00 |
| | 5° | CS 2921-05 |
| | 10° | CS 2921-10 |
| obeliscTM end piece, Ø 24 mm | 0° | CS 2922-00 |
| | 5° | CS 2922-05 |
| | 10° | CS 2922-10 |
| obeliscTM end piece, Ø 26 mm | 0° | CS 2923-00 |
| | 5° | CS 2923-05 |
| | 10° | CS 2923-10 |
| obeliscTM end piece, oval,, 32 x 26 mm | 15° | CS 2924-15 |
| obeliscTM locking screw | | CS 2901 |

Table: obelisc " Vertebral Body Replacement implant product list

The implant components of this system are made from alloyed titanium according to ISO 5832-3:2000 and ASTM F-136-02a.

## Intended Use

Vertebral body replacement intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture). The obelise TM Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of bone grafting material with the obelise™ Vertebral Body Replacement is optional.

## Substantial Equivalence

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This device is substantially equivalent to the following legally marketed devices:

| 510(k) Reference | Description | Submitted By |
|------------------|------------------------------------------------|----------------------|
| K050850 | XPAND Corpectomy<br>Spacer | Globus Medical, Inc. |
| K012254 | VBR TM Vertebral Body<br>Replacement Device | Osteotech, Inc. |

A comparison of devices is provided below (table follows on next page):

| | obeliscTM Vertebral<br>Body Replacement | XPAND | VBRTM |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Intended use | Vertebral body<br>replacement; for use<br>with supplemental<br>spinal fixation systems | Vertebral body<br>replacement; for use<br>with supplemental<br>spinal fixation systems | Vertebral body<br>replacement; for use<br>with supplemental<br>spinal fixation systems |
| Anatomical sites | Thoracic and lumbar<br>spine (T1-L5) | Thoracic and lumbar<br>spine (T1-L5) | Thoracic and lumbar<br>spine (T1-L5) |
| Material | Titanium alloy | Titanium alloy | Titanium alloy |
| Bone graft<br>material | Narrow build to permit<br>external bone graft<br>material; may also be<br>filled | Axial hole for bone graft<br>material | Hollow core for bone<br>graft material |
| Diameter | 20-30mm | Various fixed heights &<br>footprints | 12-16mm, 20-28mm |
| Distraction length | 20-132mm | Various fixed heights &<br>footprints | 10-130mm |
| Exact height<br>adjustment in situ | Continuous in-situ<br>distraction | Continuous in-situ<br>distraction | Continuous in-situ<br>distraction |
| Contact areas | Large contact areas.<br>Additional application of<br>bone graft outside the<br>implant may enhance<br>the fusion mass. | N/A | Large contact areas.<br>Additional application of<br>bone graft outside the<br>implant may enhance<br>the fusion mass. |

## Summary of Testing

Mechanical testing was performed in accordance with ASTM F 2077 - 00 (Test Methods for Intervertebral Body Fusion Devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ulrich GmbH & Co. KG % Emergo Group, Inc. Mr. Ian P. Gordon Senior Vice President 2454 McMullen Booth Road, Suite 427 Clearwater, Florida 33759

Re: K060416

Trade/Device Name: obelisc™ Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: October 31, 2006 Received: November 1, 2006

Dear Mr. Gordon:

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.

DEC 2 6 2006

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

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Page 2 - Mr. Ian P. Gordon

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" (21 CFR 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 vours.

Barbara Buckner

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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#### Indications for Use

# 510(k) Number (if known): Kolo 04 od of of

Device Name: obelisc™ Vertebral Body Replacement

#### Indications for Use:

Vertebral body replacement intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The obelisc™ Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of bour grafting material with the obelisc™ Vertebral Body Replacement is optional.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchm

(Division Sign Ori) Division of General, Restorative, and Neurological Devices

510(k) Number K060416