SPINE FRONTIER INDUS ACP SYSTEM

K121060 · Spinefrontier, Inc. · KWQ · Jul 3, 2012 · Orthopedic

Device Facts

• Record ID: K121060
• Device Name: SPINE FRONTIER INDUS ACP SYSTEM
• Applicant: Spinefrontier, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 3, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SpineFrontier Indus™ ACP System (Indus™ Invue™, Indus™ Invue™2, Indus™ Inset™) is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications.

Device Story

SpineFrontier Indus™ ACP System is a spinal intervertebral body fixation orthosis consisting of titanium alloy (Ti-6Al-4V ELI) plates and screws. Used by surgeons in clinical settings to provide temporary stabilization during cervical spinal fusion (C2-T1). Components are non-sterile, single-use, and available in various sizes/shapes. Screws are self-tapping or self-drilling. Device provides mechanical support to the spine to facilitate fusion; clinical decision-making is based on patient history and radiographic studies. Benefits include stabilization of the cervical spine in patients with degenerative, traumatic, or deformity-related conditions.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, specifically mechanical performance assessments per ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model).

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F 136. Components: Plates and screws (self-tapping/self-drilling). Form factor: Multi-level fixation (one to four levels). Energy source: None (mechanical). Sterilization: Non-sterile (user-sterilized).

Indications for Use

Indicated for patients requiring anterior cervical spine fixation (C2-T1) for temporary stabilization during fusion. Conditions include symptomatic spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, degenerative disc disease, and failed prior fusion/instability.

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

• Indus™ Anterior Cervical Plate System (K093776)
• Verteview ACP System (K050588)
• Helix Mini ACP System (K073275)
• Anterior CSLP System (K030866)

Submission Summary (Full Text)

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JUL

3 2012

#### 5.0 510(k) Summary

## 1. Sponsor

SpineFrontier, Inc. 500 Cummings Center Suite 3500 Beverly, MA 01915

| Primary Contact: | Fredy H. Varela, RAC<br>Regulatory Affairs Specialist |
|------------------|-------------------------------------------------------|
| Telephone: | 1-978-232-3990 |
| Date Prepared: | April 3, 2012 |

## 2. Device Name and Classification:

SpineFrontier Indus™ ACP System Proprietary Names:

Common/Usual Name: Spinal Intervertebral Body Fixation Orthosis

Classification Name: Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060), Class II

KWQ Product Code:

## 3. Predicate Devices

K093776- SpineFrontier - Indus™ Anterior Cervical Plate System K050588- Innovative Spinal - Verteview ACP System K073275- NuVasive - Helix Mini ACP System K030866- Synthes - Anterior CSLP System

## 4. Device Description

The SpineFrontier Indus™ ACP System consists of a variety of shapes and sizes of plates, screws, and associated instruments. The plates are available in four levels to accommodate one to four levels of fixation. The screws come as self tapping or self drilling in various lengths and diameters. The SpineFrontier Indus™ ACP System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V El.I) that conforms to ASTM F 136.

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This submission is being provided for design changes to the previously cleared Indus™ Anterior Cervical Plate System (K093776).

## 5. Intended Üse

The SpineFrontier Indus" ACP System (Indus™ Invue™, Indus™ Invue "2, Indus™ Inset™) is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above. indications.

## 6. Technological Characteristics

The SpineFrontier Indus" ACP System System was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles and materials.

The SpineFrontier Indus™ ACP System has been shown to be substantially equivalent to predicate devices in terms of performance (mechanical testing). Clinical data was not required for this device.

# 7. Basis for Substantial Equivalence

The SpineFrontier Indus" ACP System was evaluated in accordance with FDA Document, Guidance for Industry and FDA Staff' - Spinal System 510(k)s, May 3, 2004, and has been found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of indications for use, function, materials, and performance (mechanical testing). Clinical data was not required for this device. Mechanical testing includes performance assessments per the following recognized test methods:

- ASTM Standard F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
### Special 510(k) Premarket Notification

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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 stylized eagle or bird symbol, with three curved lines representing its body and wings. The logo is surrounded by text that reads "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

SpineFrontier, Inc. % Fredy H. Varela, RAC Regulatory Affairs Specialist 500 Cummings Center, Suite 3500 Beverly, Massachusetts 01915

3 2012 JUL

Re: K121060

> Trade/Device Name: Indus ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 2, 2012 Received: June 7, 2012

## Dear Mr. Varela:

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.

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Page 2- Fredy H. Varela, RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised hite i Dri bisean.to vour device complies with other requirements of the Act that i Dri has made a aved regulations administered by other Federal agencies. You must or any I catal statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the rece 31equiremansmally, medical device reporting (reporting of medical CI it i art 007), laboring (DF CFR 803); good manufacturing practice requirements as set de vice-related daverse ovenis) (2 regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific ad resources offices/CDRH/CDRHOffices/ucm115809.htm for go to hap. W. W. Madiological 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 I ou may 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,

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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#### 4.0 Indications for Use Statement

## 510(k) Number (if Known):

# Device Name: SpineFrontier Indus™ ACP System

### Indications For Use:

The SpineFrontier Indus™ ACP System (Indus™ Invue™, Indus™ Invue™2, Indus Inset") is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications.

Prescription Use: X

OR

Over-The-Counter Use: (Part 21 CFR 807.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

- 3.

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

K121060 510(k) Number_