FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5

K042713 · Spine Next America Corporation · MQP · Dec 29, 2004 · Orthopedic

Device Facts

• Record ID: K042713
• Device Name: FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5
• Applicant: Spine Next America Corporation
• Product Code: MQP · Orthopedic
• Decision Date: Dec 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FIDJI type 5 is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to turnor or trauma (i.e., fracture). The device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. This device is intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System. Additionally, FIDJI type 5 is intended to be used in a paired configuration.

Device Story

Hollow, tapered PEEK blocks; designed for thoracolumbar spine (T1-L5) vertebral body replacement; includes tantalum inserts for radiographic visualization; angled teeth on cephalad/caudal surfaces for stability. Implanted by surgeons during vertebrectomy procedures; used in paired configuration; interior packed with bone graft; requires supplemental internal fixation (e.g., InCompass System). Restores biomechanical integrity of spinal column; provides structural support for collapsed/unstable vertebrae.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: PEEK Optima LT; Tantalum inserts for radiographic marking. Form factor: Hollow, tapered blocks with angled teeth. Energy source: None (mechanical). Connectivity: None. Sterilization: Sterile.

Indications for Use

Indicated for patients requiring replacement of collapsed, damaged, or unstable vertebral bodies in the thoracic or thoracolumbar spine (T1-L5) following partial or total vertebrectomy due to tumor or trauma (fracture).

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

• Vertebral Spacer (K011037)
• Vertestack (K031780)

Submission Summary (Full Text)

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DEC 2 9 2004

KO42713

# 510(k) SUMMARY

### SUBMITTED BY

Tom Brewer Spine Next America 8381 Dix Ellis Trail Suite 110 Jacksonville, Fl. 32256

September 27, 2004 Date Submitted:

### CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

| Classification Name: | Vertebral Body Replacement Device |
|-------------------------|--------------------------------------------------|
| Common/Usual Name: | Vertebral Body Replacement |
| Product Classification: | Class II |
| Proprietary Name: | Spine Next FIDJI Vertebral Body Replacement Type |

### PREDICATE DEVICE

Vertebral Spacer manufactured by Synthes [reference 510(k) K011037, cleared July 1, 20021

Vertestack manufactured by Medtronic Sofamor Danek [reference 510(k) K031780, cleared July 30, 2003]

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

### DEVICE DESCRIPTION AND MATERIALS OF CONSTRUCTION

The Spine Next FIDJI Vetebral Body Replacement Type 5 devices are hollow blocks that are machined from extruded Polyetheretherketone (PEEK); the blocks are tapered to aid in maintaining lordosis of the spine following implantation. The devices have angled teeth on the cephalad and caudal surfaces. The devices include tantalum inserts that serve as a location and orientation markers for radiographs.

# INDICATIONS FOR USE

The FIDJI vertebral body replacement type 5 device is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body

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due to tumor or trauma (i.e., fracture). The vertebral body replacement can be used with Spine Next supplemental internal fixation systems, e.g., the SHIRAZ and SHIRAZ JAVA systems. The interior of the device can be packed with bone.

| PRODUCT | FIDJI | Vertebral spacer/Vertestack |
|---------------------------|----------------|-----------------------------|
| Materials of Construction | PEEK Optima LT | PEEK Optima LT |
| Load Bearing | Yes | Yes |
| Sold sterile | Yes | Yes |
| Biocompatible | Yes | Yes |
| Same Indications | Yes | Yes |
| Similar Use/Handling | Yes | Yes |
| Provided in various sizes | Yes | Yes |

# COMPARISON TO THE PREDICATE DEVICE

Comparison of Technical Characteristics with the Predicate Device

- > Both the Spine Next Vertebral Body Replacement type 5 and the predicate devices are used as Spinal vertebral body replacements.
- > Technologically they are virtually identical in their function and principle of operation, although subtle design differences will require minor adjustments to procedure by the implanting surgeon for proper product use. Both devices are similar in that they are intended for use under load conditions.
- > Both the Spine Next Vertebral Body Replacement type 5 and the predicated devices are fabricated from PEEK Optima LT
- > All devices meet mechanical performance requirements.
- > All devices have similar indications-for-use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three overlapping shapes that resemble birds in flight.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 2004

Ms. Lisa Peterson Regulatory Affairs Manager Spinal Concepts, Inc. 5301 Riata Park Court, Building. F Austin, Texas 78727

Re: K042713

Trade/Device Name: FIDJI Vertebral Body Replacement Type 5 Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 3, 2004 Received: December 6, 2004

Dear Ms. Peterson:

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. Justin Eggleton

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 yours,

Mark A. Millman

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): K042713

Device Name:

Spinal Concepts, Inc. FIDJI Vertebral Body Replacement Type 5

Indications for Use:

FIDJI type 5 is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to turnor or trauma (i.e., fracture). The device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. This device is intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System. Additionally, FIDJI type 5 is intended to be used in a paired configuration.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Hyaluation (ODE)

(Division Sign-O0)
Division of General, Restorative,
and Neurological Devices

510(k) Number_ K042713

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