SEASPINE VBR SYSTEM

K052170 · Seaspine, Inc. · MQP · Dec 21, 2005 · Orthopedic

Device Facts

• Record ID: K052170
• Device Name: SEASPINE VBR SYSTEM
• Applicant: Seaspine, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Dec 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SeaSpine VBR System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine VBR System 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. Additionally, the SeaSpine VBR System is intended for use with bone graft.

Device Story

SeaSpine VBR System consists of straight, curved, round, and trapezoidal vertebral body replacement implants; used to replace collapsed/diseased/damaged vertebral bodies in thoracolumbar spine (T1-L5). Implants are manufactured from PEEK OPTIMA polymer with tantalum markers for radiographic visualization. System includes various surgical instruments (e.g., paddle scrapers, inserters) made of stainless steel with Radel or Pomalux handles. Devices are supplied non-sterile and require sterilization by the user. Intended for use with bone graft to restore spinal column biomechanical integrity and achieve anterior decompression. Operated by surgeons in clinical/OR settings. Output is physical structural support for the spinal column.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Implants: PEEK OPTIMA polymer with tantalum wires/beads. Instruments: Stainless steel with Radel or Pomalux handles. Form factor: Straight, curved, round, and trapezoidal shapes in various sizes. Sterilization: High-temperature steam (user-performed). Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring replacement of a collapsed, diseased, damaged, or unstable complete or partial vertebral body in the thoracolumbar spine (T1-L5) 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

• Alphatec Manufacturing NOVEL VBR Spinal System (K050553 and K042201)
• Interpore Cross GEO VBR Spinal System (K010530, K020048, and K040168)
• Quantum Vertebral Body Replacement (K050449)
• Spinal Concepts Cadence and Traxis (K033517)

Submission Summary (Full Text)

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K052170 p/3

CONFIDENTIAL

DEC 2 1 2005

#### SeaSpine VBR System

## 510(K) SUMMARY

Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.

| Submitter Information: | SeaSpine, Inc.<br>Contact: Diana Smith<br>2302 La Mirada Drive<br>Vista, CA 92081-7862<br>Phone: [phone] Fax: [phone] |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | 2032593 |
| Submission Correspondent: | SeaSpine, Inc.<br>Contact: Diana Smith, Manager of<br>Regulatory Affairs and Quality Assurance<br>2302 La Mirada Drive<br>Vista, CA 92081-7862<br>Phone: [phone] Fax: [phone] |
| Date Summary Prepared: | August 5, 2005 |
| Classification Name: | Spinal Intervertebral Body Fixation<br>Orthosis<br>MQP (Class II) - 888.3060 |
| Common/Usual Name: | Straight Vertebral Body Replacement<br>(VBR), Curved VBR, Round VBR,<br>Trapezoidal VBR, and Instruments |
| Device Trade Name: | SeaSpine VBR System |

The devices used for comparison in this summary are the Alphatec Manufacturing NOVEL VBR Spinal System (K050553 and K042201), the Interpore Cross GEO VBR Spinal System (K010530, K020048, and K040168), the Quantum Vertebral Body Replacement (K050449), and Spinal Concepts Cadence and Traxis (K033517).

1. Intended Use: (The statements of intended use are identical.)

The intended use of the SeaSpine VBR System straight, curved, round, and trapezoidal VBRs is substantially equivalent to the intended use of the predicate devices.

The SeaSpine VBR System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral

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### SeaSpine VBR System

body due to tumor or trauma/fracture, to achieve anterior decompression of the spiral cord and neural tissues, and to restore the height of a collapsed vertebral body.

The SeaSpine VBR System 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. Additionally, the SeaSpine VBR System is intended for use with bone graft.

## 2. Description:

The SeaSpine VBR System straight, curved, round, and trapezoidal VBRs are manufactured out of PEEK OPTIMA® polymer with tantalum wires and/or beads. All VBR configurations will be offered in numerous lengths and sizes. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The SeaSpine VBR System will offer a wide variety of instruments that range from paddle scrapers to inserters. These various instruments will be made primarily from stainless steel with handles made from Radel or Pomalux. These items are supplied "NON-STERILE" and must be sterilized prior to use.

## 3. Technological Characteristics:

The straight, curved, round, and trapezoidal VBRs and instruments in this notification are components of a new stand alone system called the SeaSpine VBR System. The devices in this submission have substantially equivalent technological characteristics to the predicate devices. The devices in this submission also underwent appropriate mechanical testing and those results were found to be substantially equivalent to those of the predicate devices. Refer to Table 1 on the following page, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, material, and testing.

### 4. Comparison Analysis:

The overall designs of the SeaSpine VBR System straight, curved, round, and trapezoidal VBRs are substantially equivalent to the predicate devices. See Table 1 on the following page for a comparison of the SeaSpine VBR System straight, curved, round, and trapezoidal VBRs to the predicate devices.

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## 13 K052 1 CONFIDENTIAL

A STATUS FOR COLLECT PRODUCTS AND AN AND AN AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AN

# SeaSpine VBR System

ﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

| Feature | SeaSpine VBR<br>System | Alphatec<br>NOVEL VBR<br>Spinal<br>System | Interpore<br>Cross GEO<br>VBR Spinal<br>System | Quantum<br>Vertebral<br>Body<br>Replacement | Spinal<br>Concepts<br>Cadence<br>and<br>Traxis | Substantially<br>Equivalent |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------------------------------|---------------------------------------------|------------------------------------------------|-----------------------------|
| Intended Use | The intended use of<br>the SeaSpine VBR<br>System is as a<br>vertebral body<br>replacement to<br>correct spinal<br>disorders and<br>provide stabilization<br>of the spine to permit<br>the biological<br>process of spinal<br>fusions to occur. | Similar | Similar | Similar | Similar | Yes |
| Indications<br>for Use | • Trauma/fracture<br>• Tumor | Similar | Similar | Similar | Similar | Yes |
| Design | • PEEK implants with<br>tantalum markers<br>• Multiple shapes | Similar | • Titanium<br>implants<br>• Multiple shapes | Similar | Similar | Yes |
| Straight VBR | Various sizes | Similar | Similar | Similar | Similar | Yes |
| Curved VBR | Various sizes | Similar | Similar | Similar | Similar | Yes |
| Round VBR | Various sizes | Similar | Similar | NA | NA | Yes |
| Trapezoidal<br>VBR | Various sizes | Similar | Similar | NA | NA | Yes |
| Material | PEEK and Tantalum | Similar | Titanium (per<br>ASTM F-1108) | Similar | Similar | Yes |
| Sterile | Non-sterile | Similar | Sterile and Non-<br>Sterile | Similar | Similar | Yes |
| Mechanical<br>Testing | Conducted according<br>to recognized<br>standards | Similar | Similar | Similar | Similar | Yes |
| Method of<br>Sterilization | High-temperature<br>steam | Similar | Similar | Similar | Similar | Yes |

Table 1: Summary of Design Comparison

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2005

Ms. Diana Smith Manager of Regulatory Affairs & Quality Assurance SeaSpine, Inc. 2302 La Mirada Drive Vista, California 92081-7862

Re: K052170

Trade/Device Name: SeaSpine Vertebral Body Replacement (VBR) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: MOP Dated: December 1, 2005 Received: December 2, 2005

Dear Ms. Smith:

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 mav 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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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,

Mark N. Melkerson,

ﮨﮯ 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 Statement

510(k) Number (if known): 1052170

Device Name: SeaSpine VBR System

Indications for Use:

2100-1 Niin

The SeaSpine VBR System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The SeaSpine VBR System 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. Additionally, the SeaSpine VBR System is intended for use with bone graft.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter-Use<br>(21 CFR 807 Subpart C) | |

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

(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,

and Neurological Devices

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