Nautilus Spinal System

K151196 · Life Spine, Inc. · NKB · Jul 14, 2015 · Orthopedic

Device Facts

• Record ID: K151196
• Device Name: Nautilus Spinal System
• Applicant: Life Spine, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Jul 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 presence of incomplete bone healing. The NAUTILUS Thoracolumbar Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis (4.75 systems only). It provides stabilization of spinal segments as an adjunct to fusion. Pediatric pedicle screw fixation is limited to a posterior approach. When used as a posterior spine thoracic/lumbar system, the NAUTILUS Thoracolumbar 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. In order to achieve additional levels of fixation in skeletally mature patients, the NAUTILUS Thoracolumbar Spinal System 5.5 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm roc. bone healing.

Device Story

Nautilus Spinal System consists of titanium alloy and cobalt chrome rods, screws, cross connectors, and axial/offset connectors; used as load-sharing internal fixation implants to stabilize and maintain spinal alignment until bone healing occurs. Operated by surgeons in clinical settings; provides posterior pedicle screw fixation for thoracic/lumbar spine. System components are assembled during manufacturing; intended for single use. Provides stabilization as an adjunct to fusion; helps treat various spinal pathologies including degenerative disc disease, trauma, and deformities. Benefits patient by providing structural support during healing process.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F1717 (static/dynamic compression, static torsion) and ASTM F1798 (static axial grip, torsional grip, moment bending) to demonstrate substantial equivalence.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and cobalt chrome per ASTM F1537. Components: Rods, screws, cross/axial/offset connectors. Form factor: Posterior pedicle screw fixation system. Connectivity: None (mechanical). Sterilization: Non-sterile, single-use.

Indications for Use

Indicated for posterior pedicle screw fixation of non-cervical spine in skeletally mature patients and pediatric patients with adolescent idiopathic scoliosis (4.75 systems only). Used for stabilization as adjunct to fusion in cases of degenerative disc disease, trauma, spinal curvatures, tumor, failed fusion, pseudarthrosis, spinal stenosis, and spondylolisthesis. Pediatric use limited to posterior approach.

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

• Nautilus Spinal System (K141222)
• Arx Spinal System (K061600)
• Pilot Spinal System (K111729)
• Globus Creo Stabilization System (K143633)
• Medtronic CD Horizon (K143569)

Reference Devices

• Solstice OccipitoCervicoThoracic Fixation System

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.

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

Life Spine, Incorporated Mr. Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142

Re: K151196

Trade/Device Name: Nautilus Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI Dated: May 18, 2015 Received: May 19, 2015

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 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

July 14, 2015

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Page 2 - Mr. Randy Lewis

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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Mark N. Melkerson -S

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) K151196

Device Name Nautilus Spinal System

#### Indications for Use (Describe)

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 presence of incompleteInternal 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 bresence of incomplete bone healing.

The NAUTILUS Thoracolumbar Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis (4.75 systems only). It provides stabilization of spinal segments as an adjunct to fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

When used as a posterior spine thoracic/lumbar system, the NAUTILUS Thoracolumbar 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.

In order to achieve additional levels of fixation in skeletally mature patients, the NAUTILUS Thoracolumbar Spinal System 5.5 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm roc. bone healing.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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## 510(k) Summary Nautilus® Spinal System

| Submitted By: | Life Spine, Inc.<br>13951 S. Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis<br>Life Spine<br>13951 S. Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | April 30th, 2015 |
| Trade Name: | Nautilus Spinal System |
| Regulation Name: | 888.3070 Pedicle Screw Spinal System |
| Classification: | NKB, CFR 888.3070, Class III<br>MNH, CFR 888.3070, Class II<br>MNI, CFR 888.3070, Class II<br>OSH, CFR 888.3070, Class II |
| Primary Predicate: | The Nautilus Spinal System (K141222) |
| Additional Predicates: | The Arx Spinal System (K061600)<br>The Pilot Spinal System (K111729)<br>The Globus Creo Stabilization System (K143633)<br>Medtronic CD Horizon (K143569) |

## Device Description:

The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.

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The purpose of this submission is to add new screw iterations to the Nautilus Spinal System.

#### Indications for Use of the Device:

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 NAUTILUS Thoracolumbar Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis (4.75 systems only). It provides stabilization and immobilization of spinal segments as an adjunct to fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

When used as a posterior spine thoracic/lumbar system, the NAUTILUS Thoracolumbar 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.

In order to achieve additional levels of fixation in skeletally mature patients, the NAUTILUS Thoracolumbar Spinal System 5.5 rod system may be connected to the Solstice-OccipitoCervicoThoracic Fixation System's 3.5mm rod.

## Technological Characteristics:

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

## Material:

The NAUTILUS Spinal System is 6AL-4V-ELI titanium manufactured according to ASTM F136 and cobalt chrome per ASTM 1537. The device is comprised of a variety of non-sterile titanium, single use components.

#### Performance Data:

Mechanical testing was included to demonstrate the substantial equivalency of the Nautilus Spinal System. The testing included static and dynamic compression and static torsion testing per ASTM F1717 as well as static axial grip, torsional grip and moment bending per ASTM F1798.

#### Conclusion:

The information presented demonstrates the substantial equivalency of the Nautilus Spinal System.