CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM

K120570 · Choicespine, LP · MQP · Apr 5, 2012 · Orthopedic

Device Facts

• Record ID: K120570
• Device Name: CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM
• Applicant: Choicespine, LP
• Product Code: MQP · Orthopedic
• Decision Date: Apr 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Choice Spine Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The VBR device is intended for use with supplemental fixation & is to be used with autograft and/or allograft bone graft material.

Device Story

The Choice Spine VBR System is an implantable spinal device designed to replace collapsed, damaged, or unstable vertebral bodies in the thoracolumbar spine (T1-L5). The device features an oval-shaped, hollow body to accommodate bone graft material and includes superior and inferior surface ridges (teeth) to resist migration. Available in various heights and lordotic angles to match patient anatomy, the device is implanted by a surgeon during spinal procedures. It requires the use of supplemental fixation hardware and autograft or allograft bone graft to facilitate fusion. The device provides structural support to the spinal column, aiming to restore stability following tumor resection or traumatic fracture.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F2267-04 (load-induced subsidence) and ASTM F2077-03 (static/dynamic compression and torsion).

Technological Characteristics

Implant manufactured from PEEK OPTIMA (ASTM F2026) with tantalum radiopaque markers (ASTM F560). Oval-shaped hollow geometry with surface ridges for migration resistance. Available in multiple heights and lordotic angles.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma (fracture). Must be used with supplemental fixation and autograft/allograft bone graft.

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 Spine Novel VBR Spinal System (K050553)
• Globus Medical NIKO Corpectomy Spacer (K072465)
• Verticor Samson Corpectomy Cage (K091426)

Submission Summary (Full Text)

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## 510(k) Summary

#### Preparation Date

22 February 2012

#### Sponsor

Choice Spine, LP 400 Erin Drive Knoxville, TN 37919 p: 865.246.3333 f: 865.588.4045

#### Contact

Mark Bekkala

#### Trade Name

Choice Spine Vertebral Body Replacement (VBR) System

#### Common Name

Spinal Vertebral Body Replacement Device

# Regulatory Classification & Device Product Codes

888.3060 MQP – Spinal intervertebral body fixation orthosis

### Predicate Devices

Alphatec Spine Novel VBR Spinal System (K050553) Globus Medical NIKO Corpectomy Spacer (K072465) Verticor Samson Corpectomy Cage (K091426)

#### Device Description

The Choice Spine Vertebral Body Replacement (VBR) System devices have a basic oval shape with a hollow center for placement of bone graft. The superior & inferior surfaces have ridges, or 'teeth' for resisting migration. The devices are available in an assortment of heights & multiple angles of lordosis to accommodate different anatomic requirements.

#### Intended Use

The Choice Spine Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The VBR device is intended for use with supplemental fixation & is to be used with autograft and/or allograft bone graft material.

Choice Spine VBR System

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### 510(k) Summary (continued)

#### Materials

The Choice Spine Vertebral Body Replacement (VBR) System is manufactured from Polyetheretherketone (PEEK OPTIMA® from Invibio®) per ASTM F2026. Integral radiopaque markers are manufactured from tantalum per ASTM F560.

#### Technological Characteristics

The Choice Spine Vertebral Body Replacement (VBR) System consists of implant devices with a range of depths, widths, heights, & angles of lordosis similar to the identified predicate systems.

The Intended Use of the Choice Spine Vertebral Body Replacement (VBR) System is identical to the predicate systems. The Choice Spine Vertebral Body Replacement (VBR) System materials are similar to the predicate systems.

#### Substantial Equivalence

Documentation was provided that demonstrates the Choice Spine Vertebral Body Replacement (VBR) System to be substantially equivalent to previously cleared device systems. The substantial equivalence is based upon equivalence in intended use, indications, anatomic location, materials, & performance. Mechanical testing was performed according to the guidelines outlined in ASTM F2267-04 "Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression" & ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices". Testing parameters executed were static compression, dynamic compression, static torsion, dynamic torsion, subsidence, & expulsion.

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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 features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Choice Spine, LP % Mr. Mark Bekkala 400 Erin Drive Knoxville, Tennessee 37919

APR - 5 2012

Re: K120570

Trade/Device Name: Choice Spine Vertebral Body Replacement (VBR) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: March 19, 2012 Received: March 20, 2012

Dear Mr. Bekkala:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice related adverse overals) (2) 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. Mark Bekkala

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eunel Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indication for Use Statement

510(k) Number (if known): _ K120570

Device Name: Choice Spine Vertebral Body Replacement (VBR) System

Indications for Use:

The Choice Spine Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The VBR device is intended for use with supplemental fixation & is to be used with autograft and/or allograft bone graft material.

Prescription Use _ × (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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K120570 510(k) Number.