ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT

K032812 · Orthovita, Inc. · MQP · Dec 8, 2003 · Orthopedic

Device Facts

• Record ID: K032812
• Device Name: ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT
• Applicant: Orthovita, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Dec 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endoskeleton TA VBR is for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Endoskeleton TA VBR is intended for use with supplemental internal spinal fixation systems. The Endoskeleton TA VBR may be used with bone graft material or bone graft substitute.

Device Story

Endoskeleton TA VBR is a titanium vertebral body replacement implant; oval-shaped; hollow center for bone graft material; roughened surface for stability. Used in thoracolumbar spine (T1-L5) to replace damaged/unstable vertebrae due to tumor or trauma. Implanted via anterior surgical approach by a surgeon; requires supplemental internal spinal fixation. Available in various sizes and 0-7 degree lordotic angles to restore spinal alignment. Customized instruments facilitate implantation. Benefits include structural support for the spine and potential for fusion when used with bone graft.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Titanium implant; oval shape; hollow center for bone graft; roughened surface; available in various sizes and 0-7 degree lordotic angles. Manual implantation via customized instruments. No software or electronic components.

Indications for Use

Indicated for patients with collapsed, damaged, or unstable vertebral bodies in the thoracolumbar spine (T1-L5) resulting from tumor or trauma (fracture). Requires use 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

• DePuy Acromed Stackable Cage (K990148, K013382)
• Synthes Vertebral Spacer Ti (K020152, K024364)

Submission Summary (Full Text)

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K0328/2

2

DEC - 8 2003

## 510(K) SUMMARY FOR THE ORTHOVITA, INC. ENDOSKELETON TA VBR

# Submitter's Name, Address, Telephone Number, And Contact Person

Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355 Contact: David McIlhenny [phone] Telephone: Facsimile: [phone]

### Date Prepared

September 4, 2003

#### Name of the Device

Endoskeleton TA Vertebral Body Replacement

## Common or Usual Name

Vertebral Body Replacement

### Classification Name

Vertebral Body Replacement (MQP)

#### Predicate Devices

- DePuy Acromed Stackable Cage (K990148, K013382) ●
- Synthes Vertebral Spacer Ti (K020152, K024364) .

#### Intended Use

The Endoskeleton TA VBR is for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Endoskeleton TA VBR is intended for use with supplemental internal spinal fixation systems. The Endoskeleton TA VBR may be used with bone graft material or bone graft substitute.

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K032012

The principles of operation of the modified device are identical to the other previously cleared VBR systems. Like the predicate VBRs, the Endoskeleton TA VBR is inserted in the spine together with supplemental internal spinal fixation. Bonc graft material may be placed in and/or around the implant. One implant is inscrted per spinal level via an anterior surgical approach.

# Technological Characteristics

The Endoskeleton TA VBR is a titanium implant that is oval in shape. The implant is available in a range of sizes in 0-7º lordotic angles, higher in the anterior than the posterior, to restore spinal lordosis. The center of the implant is hollow and can be filled with bone graft material. The device is available in a range of sizes to accommodate the individual patient's anatomic space. The surface of the implant is roughened to improve stability and resistance to expulsion. A set of customized instruments will be provided for use with the Endoskeleton TA VBR to facilitate its implantation.

# Summary Basis for the Finding of Substantial Equivalence

The Endoskeleton TA VBR described in this submission has same intended use and very similar indications for use and technological features to a number of other previously cleared VBR devices. The implantation procedure for the Endoskeleton TA VBR also is substantially similar to other currently available VBRs. Any minor differences between the Endoskeleton TA VBR and the predicates do not raise any new tvpes of safety or effectiveness issues, and performance data in the submission demonstrate that these differences do not adversely impact its safety or effectiveness. Therefore, the Endoskeleton TA VBR is substantially equivalent.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem that features a stylized representation of a human figure, with three curved lines forming the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2003

Mr. David McIlhenny Senior Vice President, Operations Orthovita, Inc. 45 Great Valley Parkway Malvern, Pennsylvania 19355

Rc: K032812

Trade/Device Name: Orthovita Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP Dated: September 5, 2003 Received: September 9, 2003

Dear Mr. McIlhenny:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (for the indications for use stated in the enclosure) to legally marketed prodicate 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 elcctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David McIlhenny

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 vours.

Sincerely yours,

/ Mark N Millkerm

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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## Indications for Use Statement

510(k) Number (if known): K032812

Device Name: Orthovita Vertebral Body Replacement

Indications for Use:

The Endoskeleton TA VBR is for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Endoskeleton TA VBR is intended for use with supplemental internal spinal fixation systems. The Endoskeleton TA VBR may be used with bone graft material or bone graft substitute.

f. Mark A. Milburn

Memorogical Devices

Number K032812

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

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Over-The-Counter Use -