PILOT SPINAL SYSTEM

K111729 · Life Spine, Inc. · NKB · Sep 7, 2011 · Orthopedic

Device Facts

• Record ID: K111729
• Device Name: PILOT SPINAL SYSTEM
• Applicant: Life Spine, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Sep 7, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing. The PILOT® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities. When used as a posterior spine thoracic/lumbar system, the PILOT® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

Device Story

PILOT Spinal System comprises titanium alloy rods, screws, and side-loading bodies; designed for posterior pedicle screw fixation in thoracic/lumbar spine. System provides stabilization and immobilization of spinal segments as adjunct to fusion. Operated by surgeons in clinical/OR settings. Modification enhances force transfer efficiency. Components are single-use; must not be mixed with other manufacturers' systems or stainless steel components. Device acts as load-sharing implant to maintain alignment during bone healing.

Clinical Evidence

Bench testing only. Static and fatigue test data in accordance with ASTM F1717 were presented to demonstrate substantial equivalency.

Technological Characteristics

6AL-4V-ELI titanium alloy (ASTM F136). Components include rods (5.5mm or 6.35mm diameter), screws, and side-loading bodies. Non-sterile, single-use. Mechanical fixation via pedicle screw system.

Indications for Use

Indicated for skeletally mature patients requiring posterior pedicle screw fixation of the non-cervical spine as an adjunct to fusion for degenerative disc disease, trauma, spinal curvatures (scoliosis, kyphosis, lordosis), spinal tumor, failed previous fusion, pseudarthrosis, spinal stenosis, or spondylolisthesis.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• PILOT Spinal System (K063601)
• PILOT Spinal System (K083865)

Submission Summary (Full Text)

{0}------------------------------------------------

K1117-29
Page 1 of 2

| SEP - 7 | 2011 |
|---------|------|
|---------|------|

## 510(k) Summary PILOT® Spinal System

| Submitted By: | Life Spine, Inc.<br>2401 W. Hassell Road, Suite 1535<br>Hoffman Estates, IL 60169<br>Telephone: [phone]<br>Fax: [phone] |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis<br>Life Spine<br>2401 W. Hassell Road, Suite 1535<br>Hoffman Estates, IL 60169<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | June 17th, 2011 |
| Trade Name: | PILOT Spinal System |
| Common Name: | Pedicle screw spinal system |
| Classification: | Class III |
| Product Code: | NKB, MNH, MNI |
| Predicate Device: | PILOT Spinal System (K063601), (K083865) |

#### Device Description:

The PILOT® Spinal System consists of an assortment of rods, screws, and bodies in various shapes ITIC I THE PILOT® Spinal System side loading bodies are designed to accept either a 5.5mm or 6.35mm diameter rod. The rods are either pre-lordosed or straight.

The proposed modification to the PILOT Spinal System enhances the ease of use of the system by increasing the force transfer efficiency.

The PILOT® Spinal System implant components are made from titanium alloy described by ASTM F 136. Stainless steel and titanium implant components must not be used together in a construct. Do r 150. Sameess steel and notes spinal System components with the components from any other system or manufacturer. The PILOT® Spinal System components should never be reused under any circumstances.

{1}------------------------------------------------

# Intended Use of the Device:

Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until Internal fixation intplants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The PILOT® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the The FIEO - Spinal System, when proporty and ents. It provides stabilization and immobilization non-cervicus posterier opinat to fusion in the treatment of the following acute and chronic instabilities or deformities.

When used as a posterior spine thoracic/lumbar system, the PILOT® Spinal System is indicated for one when used as a posterior spine morative disc disease (is defined as back pain of discogenic origin of more of the lonowing: (1) degenerative and radiographic studies), (2) trauma (i.e. fracture
with degeneration of the disc confirmed by history and radiographic studies) (i with degeneration of the dise comminiss kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

## Technological Characteristics:

The PILOT Spinal System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.

#### Material:

The PILOT Spinal System is 6AL-4V-ELI titanium manufactured according to ASTM F136. The I ne 1 150 - Spinal by a variety of non-sterile titanium, single use components.

#### Performance Data:

I er formatics Data.
Static and fatigue test data in accordance with ASTM F1717 were presented to demonstrate the substantial equivalency of the PILOT Spinal System.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings, body, and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10905 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP - 7 2011

Life Spine, Inc. % Mr. Randy Lewis 2401 West Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169

Re: K111729

Trade/Device Name: PILOT® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: August 04. 2011 Received: August 08, 2011

Dear Mr. Lewis:

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

{3}------------------------------------------------

Page 2 – Mr. Randy Lewis

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.

If vou 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.ida.gov/MedicalDevices/Safety/ReportalProblem/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.

E. L. Keith

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

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) number (if known): _ K // / 729

## Device Name: PILOT® Spinal System

Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The PILOT® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.

When used as a posterior spine thoracic/lumbar system, the PILOT® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis,

Prescription Use _ x _ (Part 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)

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

510(k) Number K111729