← Product Code [MRW](/productcode/MRW) · K123218

# ILLICO FS FACET FIXATION SYSTEM (K123218)

_Alphatec Spine, Inc. · MRW · Nov 28, 2012 · OR · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K123218

## Device Facts

- **Applicant:** Alphatec Spine, Inc.
- **Product Code:** [MRW](/productcode/MRW.md)
- **Decision Date:** Nov 28, 2012
- **Decision:** SESE
- **Submission Type:** Special
- **Device Class:** Class U
- **Review Panel:** OR
- **Attributes:** Therapeutic

## Indications for Use

The ILLICO® FS System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The ILLICO FS System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1 inclusive. The ILLICO FS System is indicated for treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies degenerative disease of the facets with instability trauma (i.e. fracture or dislocation) spondylolisthesis spondylolysis pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity

## Device Story

ILLICO FS Facet Fixation System provides bilateral spinal stabilization to aid fusion. System comprises titanium alloy (Ti-6AI-4V ELI) facet screws (4.5mm/5.0mm diameters) and instrumentation. Screws are dual-lead, self-tapping, with hexalobular drive and spherical washer interface to accommodate anatomical angulation. Used in conventional or percutaneous surgical procedures by surgeons to immobilize facet joints at L1-S1 levels. Washer distributes compression force to reduce stress on inferior facet joint. Device provides mechanical fixation to stabilize spine, potentially reducing pain and deformity associated with degenerative disease, trauma, or failed prior fusion.

## Clinical Evidence

Bench testing only. Mechanical performance evaluated via static and dynamic testing, including torsion yield strength, pull-out force, and static/dynamic bending, conducted in accordance with ASTM F543-07 and ASTM F2193-02 standards. Results demonstrated substantial equivalence to predicate devices.

## Technological Characteristics

Materials: Surgical grade titanium alloy (Ti-6AI-4V ELI). Design: Dual-lead, self-tapping screws with hexalobular drive and spherical washer. Dimensions: 4.5mm and 5.0mm diameters. Standards: Thread profile per ASTM F543-07; mechanical testing per ASTM F543-07 and ASTM F2193-02. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

## Predicate Devices

- RaptorTM Facet Fixation System - [K110170](/device/K110170.md)
- Chameleon Fixation System - [K071420](/device/K071420.md)

## Submission Summary (Full Text)

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## 510(k) Summary

ILLICO® FS Facet Fixation System Date Prepared: July 20th, 2012

NOV 2 8 2012

| I    | Company:                     | Alphatec Spine, Inc.<br>5818 El Camino Real<br>Carlsbad, CA 92008.<br>USA                        |
|------|------------------------------|--------------------------------------------------------------------------------------------------|
| II.  | Contact:                     | Trevor J. Denbo<br>Regulatory Affairs Specialist<br>Telephone: 760-494-6951<br>Fax: 760-431-0289 |
| III. | Product Name:                | ILLICO® FS FACET FIXATION SYSTEM                                                                 |
| IV.  | Common Name:                 | Facet Screw Spinal Device                                                                        |
| V.   | Regulation Number:           | None                                                                                             |
| VI.  | Classification Product Code: | MRW                                                                                              |
| VII. | Predicate Devices:           | RaptorTM Facet Fixation System - K110170<br>Chameleon Fixation System - K071420                  |

### VIII. Description:

The ILLICO FS System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The system is comprised of the Facet Screw and Facet Lag Screw offered in two diameters (4.5mm and 5.0mm) and instrumentation. The implant provides bilateral facet fixation, with or without bone graft, at single or multiple levels and can be used in conventional or percutaneous surgical procedures. The implants are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI).

#### IX. Indications for Use:

The ILLICO® FS Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. ILLICO® FS Facet Fixation System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1-S1 inclusive. The facet fixation system is indicated for treatment of any or all of the following:

- degenerative disc disease (DDD) as defined by back pain of discogenic origins i confirmed by history and radiographic studies
- degenerative disease of the facets with instability ।
- trauma (i.e. fracture or dislocation) ।
- spondylolisthesis

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- spondylolysis
- pseudoarthrosis and failed previous fusion which are symptomatic or which may ・ cause secondary instability or deformity

#### X. Summary of the Technological Characteristics:

The technological characteristics, materials, and indications for use of the ILLICO® FS Facet Fixation System is substantially equivalent to the previously cleared predicates. The subject device differs from the predicates as follows:

- Addition of Facet Screws with diameters of 4.5mm and Facet Lag Screws with . diameters of 4.5mm and 5.0mm and a range of lengths for each.
- A minor dimensional change of the screw head and screw driver .

The facet screw is a dual lead self-tapping titanium screw with a positive (male) hexalobular drive feature. The spherical feature of the screw mates with the spherical surface of the washer allowing for angulations of the washer to accommodate differences in the anatomy between patients. The washer also distributes the compression force across a larger surface area, reducing the stress on the dorsal surface of inferior facet joint. The internal threads located in the hexalobular feature are used if axial force is needed during the removal of the screw. The ILLICO® FS Facet Fixation System thread profile is designed to the standard for cortical bone screws (ASTM F543-07). The thread is also a dual lead, which minimizes the number of rotations needed to implant the screw. The integral tapping flutes allow the screw to be placed without tapping prior to screw placement

#### XI. Discussion of the Non-clinical Testing:

Mechanical static and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. Performance testing was performed comparing the subject and predicate devices per the recognized consensus standards and per the guidance document, Guidance for Industry and FDA Staff: Spinal System 510(k)s (2004). The following testing was performed per ASTM F 543-07 and ASTM F 2193-02:

- . Torsion Yield Strength
- . Pull Out Force
- . Static Bending and Dynamic Testing

The above tests produced acceptable results and demonstrate that the ILLICO® FS Facet Fixation System is substantially equivalent to the predicate devices.

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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 symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion on the left. The eagle symbol is composed of three thick, curved lines that suggest the shape of a bird in flight. The text is in all caps and is arranged to follow the curve of the circle.

#### Public Health Service

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

November 28, 2012

Alphatec Spine, Incorporated % Mr. Trevor J. Denbo Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008

Re: K123218

Trade/Device Name: ILLICO FS Facet Fixation System Regulatory Class: Unclassified Product Code: MRW Dated: October 12, 2012 Received: October 31, 2012

Dear Mr. Denbo:

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 comply 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 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. Trevor J. Denbo

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/Medica!Devices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Ronald P. Jean for

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

### Enclosure

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# Indications for Use

## 510(k) Number (if known): K123218

## Device Name: ILLICO FS Facet Fixation System

Indications For Use:

The ILLICO® FS System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The ILLICO FS System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1 inclusive. The ILLICO FS System is indicated for treatment of any or all of the following:

degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies

degenerative disease of the facets with instability l

trauma (i.e. fracture or dislocation) -

spondylolisthesis -

spondylolysis

pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity

Prescription Use ਮ (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)

# Ronald P. Jean

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123218

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