CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM

K080860 · Creaspine · MQP · May 29, 2008 · Orthopedic

Device Facts

• Record ID: K080860
• Device Name: CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM
• Applicant: Creaspine
• Product Code: MQP · Orthopedic
• Decision Date: May 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance Small VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use. The use of allograft and/or autograft with the SupStance Small VBR System is optional.

Device Story

Vertebral body replacement system; replaces collapsed, damaged, or unstable vertebral bodies in thoracolumbar spine (T1-L5). Implant consists of hollow, trapezoidal PEEK cage with integral end caps; features serrated end caps for vertebral endplate fixation; available in various heights and sagittal angles (0°, 5°, 8°). Used by surgeons in clinical settings; implanted via anterior or costo-transverse approach. Requires supplemental internal fixation (e.g., plates/screws, rods). Optional use of allograft/autograft for fusion. Provides structural support to spinal column; aids in stabilization following tumor or trauma management.

Clinical Evidence

Bench testing only. Mechanical testing performed per FDA guidance for spinal systems, including static and dynamic compression, static and dynamic torsion, and expulsion testing. No clinical data provided.

Technological Characteristics

Material: Poly-ether-ether-ketone (PEEK) with 6% BaSO4 contrast filler. Design: Hollow trapezoidal cage with integral end caps. Dimensions: 12mm and 16mm sizes; 18mm to 50mm heights. Sagittal angles: 0°, 5°, 8°. Fixation: Serrated end caps. Energy source: None (mechanical). Connectivity: None. Sterilization: Provided non-sterile.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to collapsed, damaged, or unstable vertebral bodies resulting from tumor or trauma (fracture). Must be used with supplemental internal 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

• Surgical Titanium Mesh™ System (K003043)
• Surgical Dynamics Mesh Cage System (K003709)
• Spine Wave StaXx™ XD System (K052670)

Submission Summary (Full Text)

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## MAY 2 9 2008

## 510(K) SUMMARY

## Creaspine SupStance Small Vertebral Body Replacement System

| Proprietary Name: | Creaspine SupStance Small Vertebral Body<br>Replacement System |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Spinal Vertebral Body Replacement System |
| Proposed Regulatory Class: | Class II<br>Spinal intervertebral body fixation orthosis<br>21 CFR 888.3060 |
| Device Product Code: | 87 MQP, Spinal Vertebral Body Replacement Device |
| For Information Contact: | Marc Bernard<br>Regulatory Affairs Director |
| | PTIB Xavier Arnozan<br>Avenue du Haut-Lévèque<br>33600 Pessac - France<br>Telephone [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | March 26, 2008 |

#### Predicate Devices

The Creaspine SupStance Small Vertebral Body Replacement System is substantially equivalent to the following legally marketed spinal vertebral body replacement devices:

- Surgical Titanium Mesh™ System (DePuy-Acromed™, Inc., K003043) .
- Surgical Dynamics Mesh Cage System (United States Surgical, K003709) .
- Spine Wave StaXx™ XD System (Spine Wave, K052670) .

### Device Description

The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System consists of the SupStance Small VBR implants and the instrumentation required for implantation of the device. The SupStance Small VBR implant is a cage composed of fused hollow trapezoidal tubes with open sides and integral end caps. The SupStance

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Small VBR cages are available in three sizes (12mm, and 16mm) and cover a range of heights from 18mm to 50mm.

Like the sides of the cages, the SupStance Small VBR end caps have large openings for introduction of allograft and/or autograft and evenly spaced round serrations for fixation to the vertebral endplates. The end caps have a various (total) sagittal angle of 0°, 5°, and 8° to accommodate spinal anatomy.

The SupStance Small VBR cages are fabricated from poly-ether-ether-ketone (PEEK) with 6% BaSO4 contrast filler. The implants are provided non-sterile and may be implanted via an anterior approach or a costo-tranverse approach.

#### Intended Use

The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance Small VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance Small VBR System is optional.

### Statement of Technological Comparison

The subject components share the same intended use, basic design concepts, and materials as that of the predicate devices. Performance testing included the types of mechanical testing recommended for vertebral body replacement systems (static and dynamic compression testing, static and dynamic torsion testing, and expulsion testing) in the "FDA Guidance for Industry and FDA Staff, Spinal System 510(k)s" (issued May 3, The data collected confirms that the mechanical properties of the proposed 2004). SupStance Small VBR System are comparable to those of the predicate devices. The information and data collected support a claim of substantial equivalence for the proposed SupStance Small VBR System to the specified predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2008

Creaspine % Medical Device Consultants, Inc. Ms. Cynthia J. Nolte Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760

Re: K080860

Trade/Device Name: Creaspine SupStance Small Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: March 26, 2008 Received: March 28, 2008

Dear Ms. Nolte:

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 – Ms. Cynthia J. Nolte

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Survcillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millican

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): K080860

## Device Name: Creaspine SupStance Small Vertebral Body Replacement System

Indications for Use:

The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance Small VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance Small VBR System is optional.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogle for nrm
Division Sign-Off

Division of General, Restorative, and Neurological Devices

**510(k) Number** K080860

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Creaspine Traditional 510(k) SupStance Small VBR System March 26, 2008