INERTIA PEDICLE SCREW SYSTEM

K090984 · Nexxt Spine, LLC · MNI · Jun 30, 2009 · Orthopedic

Device Facts

• Record ID: K090984
• Device Name: INERTIA PEDICLE SCREW SYSTEM
• Applicant: Nexxt Spine, LLC
• Product Code: MNI · Orthopedic
• Decision Date: Jun 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inertia™ Pedicle Screw System is 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).

Device Story

Inertia™ Pedicle Screw System is a spinal fixation device consisting of rods, polyaxial screws, and set screws. Used by surgeons in clinical settings to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Components are implanted to treat acute and chronic spinal instabilities or deformities. The system provides mechanical support to the spine, facilitating fusion and potentially reducing patient pain and disability associated with spinal pathologies.

Clinical Evidence

Bench testing only.

Technological Characteristics

Components manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136. System includes rods (straight or pre-contoured), polyaxial screws, and set screws. Mechanical fixation device.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization and stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions: severe spondylolisthesis (grades 3-4, L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudarthrosis.

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.

Submission Summary (Full Text)

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## 8. 510(k) Summary

Sponsor:

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Nexxt Spine LLC 10142 Brooks School Road Fisher, IN 46037 Phone [phone] Fax [phone]

JUN 30 2009

:

| Contact Person: | Andy Elsbury, President |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proposed Trade Name: | Inertia™ Pedicle Screw System |
| Device Classification | Class II |
| Classification Name: | Orthosis, spinal pedicle fixation; orthosis, spondylolisthesis spinal fixation |
| Regulation: | 888.3070 |
| Device Product Code: | MNI; MNH |
| Device Description: | The Inertia™ Pedicle Screw System consists of rods, polyaxial screws and<br>set screws. Rods are available in either straight or pre-contoured (curved)<br>forms and in a variety of lengths. Polyaxial screws are available in a variety<br>of diameter-length combinations. Set screws are used to fasten the rod and<br>polyaxial screw. |
| Intended Use: | The Inertia™ Pedicle Screw System is intended to provide immobilization<br>and stabilization of spinal segments in skeletally mature patients as an<br>adjunct to fusion in the treatment of the following acute and chronic<br>instabilities or deformities of the thoracic, lumbar, and sacral spine: severe<br>spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative<br>spondylolisthesis with objective evidence of neurologic impairment;<br>fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous<br>fusion (pseudarthrosis). |
| Materials: | The Inertia™ Pedicle Screw System components are manufactured from<br>titanium alloy (Ti-6Al-4V) as described by ASTM F136. |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the Inertia Pedicle Screw<br>System to be substantially equivalent to previously cleared devices. The<br>substantial equivalence is based upon equivalence in basic design, intended<br>use, indications, anatomic sites and mechanical performance. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is facing to the right. The image is in black and white.

Public Health Service

Nexxt Spine, LLC % Mr. Andy Elsbury President 10142 Brooks School Road Fisher, Indiana 46037

Re: K090984

Trade/Device Name: Inertia™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: April 3, 2009 Received: April 7, 2009

Dear Mr. Elsbury:

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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

JUN 3 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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## Page 2 - Mr. Andy Elsbury

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Barbara frechund

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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K090984
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## 7. Indications for Use Statement

510(k) Number:_ K090984

Device Name: Inertia™ Pedicle Scrow System

Indications for Use:

The Inertia™ Pedicle Screw System is 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 LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

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

Over-the-Counter Use

(21 CFR 807 Subpart C)

(21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

E--2 (EXT for MXM) 6/24/09

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

510(k) Number_K-090984