NOVEL VBR SPINAL SYSTEM

K050553 · Alphatec/Nexmed · MQP · Apr 18, 2005 · Orthopedic

Device Facts

• Record ID: K050553
• Device Name: NOVEL VBR SPINAL SYSTEM
• Applicant: Alphatec/Nexmed
• Product Code: MQP · Orthopedic
• Decision Date: Apr 18, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NOVEL™ VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Novel™ VBR System is intended for use with supplemental spinal fixation systems. Specifically, the Novel™ VBR System is to be used with the Alphatec Zodiac™ Polyaxial Pedicle Screw System or the Alphatec Mirage™ Top Tightening Spinal System. Furthermore, the Novel™ VBR System is intended for use with bone graft.

Device Story

Vertebral body replacement (VBR) device; implanted into vertebral body space to restore stability. Components available in various shapes/sizes to match patient anatomy. Used in thoracolumbar spine (T1-L5) for tumor or trauma-related collapse/instability. Requires supplemental fixation (Alphatec Zodiac Polyaxial Pedicle Screw System or Mirage Top Tightening Spinal System) and bone graft. Radiographic markers (titanium or tantalum) facilitate identification. Intended for surgical use by physicians.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Titanium alloy (ASTM F-136) or PEEK (ASTM F-2026, ISO 10993). Radiographic markers: Titanium alloy (ASTM F-136) or Tantalum (ASTM F-560). Form factor: Modular vertebral body replacement components. Energy source: None (mechanical). Connectivity: None.

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 spinal fixation and 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

• NOVEL™ VBR Spinal System (titanium alloy version)

Reference Devices

• Alphatec Zodiac™ Polyaxial Pedicle Screw System
• Alphatec Mirage™ Top Tightening Spinal System

Submission Summary (Full Text)

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K050553
Page 1 of

- l. Alphatec Manufacturing, Inc. Company: 6110 Corte Del Cedro Carlsbad, CA 92009, USA [phone]
- Ellen Yarnall, Director of Regulatory Affairs Contact Person: 11.
- NOVEL™ VBR Spinal System ���. Trade/Proprietary Name:
- MQP (888.3060) Vertebral Body Replacement Device IV. Classification:

### Product Description: V.

The NOVEL™ VBR Spinal System is a vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. System components are offered in various shapes and sizes to meet individual patient anatomy. System components are manufactured from titanium alloy (ASTM F-136) or polyetheretherkeytone (PEEK) material (ASTM F 2026 and ISO 10993). A radiographic marker fabricated from titanium alloy (ASTM F-136) or tantalum (ASTM F-560) allows for easy radiographic identification.

#### VI. Intended Use:

The NOVEL™ VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Novel™ VBR System is intended for use with supplemental spinal fixation systems. Specifically, the Novel™ VBR System is to be used with the Alphatec Zodiac™ Polyaxial Pedicle Screw System or the Alphatec Mirage™ Top Tightening Spinal System. Furthermore, the Novel™ VBR System is intended for use with bone graft.

#### VII. Substantial Equivalence:

The NOVEL™ VBR Spinal System is substantially equivalent to the previously cleared NOVEL™ VBR Spinal System manufactured from titanium alloy.

#### VIII. Performance Data:

Performance data were submitted to characterize the NOVEL™ VBR Spinal System manufactured from PEEK material.

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Image /page/1/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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Public Health Service

APR 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ellen A. Yarnell Director of Regulatory Affairs Alphatec Manufacturing, Inc. 6110 Corte Del Cedro Carlsbad, California 92009

Re: K050553

Trade/Device Name: NOVEL® VBR Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: March 25, 2005 Received: March 25, 2005

Dear Ms. Yarnell:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your bectorn b x(x) fee device is substantially equivalent (for the indications ferenced above and nave decemblied by arketed predicate devices marketed in interstate for use statu in the encrosare) (o regars) to regars the Medical Device Amendments, or 10 commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug. devices mat nave occh recuired in asses approval of a premarket approval application (PMA). allu Cosmette Act (71ct) that do her required to the general controls provisions of the Act. The r ou may, mercere, mance of the Act include requirements for annual registration. Iisting of general controls provisions of ractice, 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 It hay be subject to such additions, Title 21, Parts 800 to 898 In addition. FDA can be found in the Oouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuated or a occeeded complies with other requirements of the Act that I DA has made a actorimiations administered by other Federal agencies. You must of ally it cleral statures and regulations daminds. but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTK Fart 807), adding (21 CFR Part 820), and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820), 1980-1950 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Ellen A. Yarnell

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter whil anow you to oegin manteeing your million of your device to a legally premarket notification: "The PDT Intentig stification 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 If you desire specific advice for your as 101) 276-0120 . Also, please note the regulation entitled, Connact the Office of Companise notification" (21CFR Part 807.97). You may obtain of Small other general information on your response 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,

signature

Miriam C. Provost, Ph.D. 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

510(k) Number (if known): K0505S3

Device Name: NOVEL™ VBR Spinal System

Indications for Use:

The NOVEL™ VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Novel™ VBR System is intended for use with supplemental spinal fixation systems. Specifically, the Novel™ VBR System is to be used with the Alphatec Zodiac™ Polyaxial Pedicle Screw System or the Alphatec Mirage™ Top Tightening Spinal System. Furthermore, the Novel™ VBR System is intended for use with bone graft.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. A. M.

ACTIVE

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