CO VERTEBRAL BODY REPLACEMENT

K050348 · Scient'X · MQP · May 27, 2005 · Orthopedic

Device Facts

• Record ID: K050348
• Device Name: CO VERTEBRAL BODY REPLACEMENT
• Applicant: Scient'X
• Product Code: MQP · Orthopedic
• Decision Date: May 27, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CO 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 duc to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR Ø6.2 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.

Device Story

Rectangular vertebral body replacement (VBR) spacers; implanted in thoracic/lumbar spine following full or partial corpectomy. Fabricated from PEEK; radio-translucent; includes metal wires for post-operative radiological confirmation. Interior open for bone graft; exterior surfaces ridged to resist migration. Not stand-alone; requires supplemental fixation (ISOBAR screws/rods) to ensure stability. Used by surgeons in clinical settings to replace damaged/collapsed vertebrae; provides structural support and facilitates fusion.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: Poly(ether ether ketone) (PEEK). Form factor: Rectangular spacers, 7mm-150mm height. Features: Ridged superior/inferior surfaces for endplate interface; hollow interior for bone graft; embedded metal wires for radiopacity. Non-active, mechanical implant.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement in the thoracic (T4-L5) or lumbar spine due to tumor or trauma-induced damage, collapse, or instability. Must be used with supplemental fixation (ISOBAR screws/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

• Scient'x Ellys VBR (K033109)

Submission Summary (Full Text)

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# CO Vertebral Body Replacement 510(k) Summary March 22, 2005

1150348

| Submitter | Scient'x<br>Batiment Calypso<br>Parc Ariane 3<br>78284 Guyancourt<br>FRANCE | MAY 27 2005 |
|---------------------|-----------------------------------------------------------------------------|-------------|
| Contact person | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 | |
| Trade Name | CO Vertebral Body Replacement | |
| Common name | Vertebral Body Replacement Device | |
| Classification name | Class II per 21 CFR section 888.3060 | |
| Product Code | MQP | |
| Equivalent Device | Scient'x Ellys VBR (K033109) | |

## Device Description

The CO Vertebral Body Replacements are rectangular shaped in pairs for full corpectomy or individually when only a portion of the vertebral body is resected. The interior of the spacers is open to provide space for bone graft. The implant is always implanted in the vertical position. These components are available in various heights (7mm-150mm) and cross sections to accommodate the variability of patient size, anatomic variation, and the size of the vertebral body defect. The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation and migration. The body has a multitude of holes to allow additional impaction of bone graft.

The CO components are fabricated from pure poly(ether cther ketone) (PEEK). This material closely matches the modulus of elastical 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. I wo metal wires at the opposite cads of the spacers allow radiological confirmation of the cage position post operatively.

#### Intended Use

CO 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 duc to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR Ø6.2 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.

### Summary Nonclinical Tests

The CO Vertebral Body Replacement is a modification to the Scient x Ellys VBR (K033109). It is similar in design, shape, strength, is manufactured from the same material and has the same indications.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 27 2005

Scient'X C/o Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K050348

Trade/Device Name: CO Vertebral Body Replacements Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 5, 2005 Received: May 9, 2005

Dear Mr. Webb:

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- Mr. J.D. Webb

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/industry/support/index.html.

Sincerely yours,

Atyat Purdu

Miriam C. Provost, Ph.D. Acting 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): _ k050348

Device Name: CO Vertebral Body Replacements

Indications for Use:

CO Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T1-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 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Stupt Rhodes

Orvision Sign-Off Division of General, Remative and Neurological Devices

510(k) Number K050348