DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS

K053292 · Scient'X USA, Inc. · MQP · Jan 19, 2006 · Orthopedic

Device Facts

• Record ID: K053292
• Device Name: DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS
• Applicant: Scient'X USA, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Jan 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DAVANTIS/ANTELYS Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T4-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR Ø6.2 Henispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

Device Story

Oval-shaped vertebral body replacement (VBR) spacers; implanted in vertical position to replace damaged/collapsed/unstable vertebral bodies. Fabricated from PEEK; radio-translucent; includes metal wires for post-operative radiological confirmation of position. Features three internal compartments for bone graft; ridges on superior/inferior surfaces interface with vertebral endplates to resist rotation. Used in thoracic/lumbar spine (T4-L5) following corpectomy. Not stand-alone; requires supplemental fixation (ISOBAR Ø6.2 Hemispherical Screws and Ø5.5 Rods) to enhance reconstruction stability. Implanted by surgeons in clinical/OR setting. Benefits include biomechanical interface matching cortical bone modulus, reduced stress shielding, and improved diagnostic imaging follow-up.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Material: Poly(ether ether ketone) (PEEK). Form factor: Oval-shaped spacers, 9mm-75mm heights. Features: Three internal bone graft compartments, surface ridges for rotation resistance, radio-opaque metal wires for positioning. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement in the lumbar and thoracic spine (T4-L5) due to tumor or trauma (fracture). Must be used with supplemental fixation (ISOBAR Ø6.2 Hemispherical Screws and Ø5.5 Rods).

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

• CO Vertebral Body Replacement (K050348)

Submission Summary (Full Text)

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## DAVANTIS/ANTELYS Vertebral Body Replacement 510(k) Summary

| Date | November 21, 2005 | |
|---------------------|-----------------------------------------------------------------------------|--------------|
| Submitter | Scient'x<br>Batiment Calypso<br>Parc Ariane 3<br>78284 Guyancourt<br>FRANCE | JAN 1 9 2006 |
| Contact person | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 | |
| Trade Name | DAVANTIS/ANTELYS Vertebral Body Replacement | |
| Common name | Vertebral Body Replacement Device | |
| Classification name | Class II per 21 CFR section 888.3060 | |
| Product Code | MQP | |
| Equivalent Device | CO Vertebral Body Replacement (K050348) | |

#### Device Description

The DAVANTIS/ANTELYS Vertebral Body Replacements are oval shaped. The interior of the spacers has three compartments to provide space for bone graft. The implanted in the vertical position. These components are available in various heights (9mm-75mm). The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation. The body has a multitude of holes to allow additional impaction of bone graft.

The DAVANTIS!ANTELYS components are fabricated from pure poly(ether ether ketone) (PEEK). This material closely matches the modulus of elasticity of cortical bone, improving the biomechanical interface and reducing the stress shielding effect. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. Two metal wires at the opposite ends of the spacers allow radiological confirmation of the cage position post operatively.

#### Intended Use

DAVANTIS/ANTELYS Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T4-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR Ø6.2 Henispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

#### Summary Nonclinical Tests

The DAVANTIS/ANTELYS Vertebral Body Replacement is a modification to the Scient's CO VBR (K050348). It is similar in design and strength, is manufactured from the same material and has the same indications.

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Image /page/1/Picture/1 description: The image shows a circular logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2006

Scient'x c/o J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K053292

K035272
Trade/Device Name: Davantis/Antelys Vertebral Body Replacements Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 22, 2005 Received: December 23, 2005

Dear Sir/Madam:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection of the device is substantially equivalent (for the indications ferenced above and have acterimes ally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the enactment date of the Medical Device Amendments, or to conninered proctor to May 20, 1978, are eccordance with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, mercefore, market the act include requirements for annual registration, listing of general controls proficions oractice, 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 may or satifyer to back as 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 nean r hat 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 or any I suthal States are a st is 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 - Ms. Rogers

This letter will allow you to begin marketing your device as described in your Section 510(k) rmarket 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 yours.

florbarc Buend

Mark N. Melkerson, Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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cc: HFZ-401 DMC HFZ-404 510(k) Staff
HFZ-410 Division D.O. f/t:SMC:rrr: 1/19/06

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# Indications for Use

510(k) Number (if known): _|(053292

Device Name: Davantis/Antelys Vertebral Body Replacements

Indications for Use:

Davantis/Antelys Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T4-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR 06.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Darbone Buckner for Arku

estorative. and Neurological Devices

510(k) Number K053092