INERTIA MIS PEDICLE SCREW SYSTEM

K132412 · Nexxt Spine, LLC · MNI · Oct 10, 2013 · Orthopedic

Device Facts

• Record ID: K132412
• Device Name: INERTIA MIS PEDICLE SCREW SYSTEM
• Applicant: Nexxt Spine, LLC
• Product Code: MNI · Orthopedic
• Decision Date: Oct 10, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inertia™ MIS 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 (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-SI vertebra: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Device Story

Inertia™ MIS Pedicle Screw System is a spinal fixation implant set consisting of rods, polyaxial screws, and set screws. Designed for thoracic, lumbar, and sacral spine stabilization. Subject of this 510(k) is the addition of cannulated pedicle screws to the existing system. Used by surgeons in clinical settings to provide immobilization as an adjunct to fusion. Components are implanted to stabilize spinal segments; set screws fasten rods to polyaxial screws. Benefits include structural support for spinal fusion in patients with acute/chronic instabilities or deformities.

Clinical Evidence

Bench testing only. Mechanical testing (static and dynamic compression bending, static torsion) was performed according to ASTM F1717 on the worst-case subject device and predicate device. Results demonstrated that the device met all defined acceptance criteria.

Technological Characteristics

System includes rods, polyaxial screws, and set screws. Materials are consistent with predicate devices. Mechanical testing performed per ASTM F1717. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral (T1-S2) instabilities or deformities, including severe spondylolisthesis (grades 3-4), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, spinal stenosis, 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.

Predicate Devices

• Inertia™ Pedicle Screw System (K101278, K090984)

Submission Summary (Full Text)

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# 510(k) Summarv

| Device Trade Name: | InertiaTM MIS Pedicle Screw System |
|--------------------|---------------------------------------------------------------------------------------|
| Manufacturer: | Nexxt Spine, LLC<br>14425 Bergen Blvd Suite B<br>Noblesville, IN 46060 |
| Contact: | Eric Lintula<br>Director of Engineering and Regulatory Affairs<br>Phone: [phone] |
| Date Prepared: | July 31, 2013 |
| Classifications: | 21 CFR §888.3070, Pedicle screw spinal system. |
| Class: | II |
| Product Codes: | MNH, MNI, KWP |

# Indications For Use:

The Inertia™ MIS 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 (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-SI vertebra: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

#### Device Description:

The Inertia™ MIS Pedicle Screw System consists of rods, polyaxial screws and set screws. Rods are available in either straight or pre-contoured (curved) forms and in a variety of lengths. Polyaxial screws are available in a variety of diameter-length combinations. Set screws are used to fasten the rod and polyaxial screw.

The purpose of this 510(k) is to add cannulated pedicle screws to the Inertia™ MIS Pedicle Screw System.

## Predicate Device:

The subject Inertia™ MIS Pedicle Screw System is substantially equivalent to predicate Inertia™ Pedicle Screw System (K101278, K090984) with respect to indications, design, function, and materials.

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# Substantial Equivalence:

Mechanical testing (static, dynamic compression bending, static torsion) was performed according to ASTM F1717 on the worst case subject Inertia™ MIS Pedicle Screw System and predicate Inertia™ Pedicle Screw System. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.

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Public Health Service

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

October 10. 2013

Nexxt Spine, LLC % Mr. Justin Eggleton Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12" Floor Washington, District of Columbia 20005

Re: K132412

Trade/Device Name: Inertia™ MIS Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI. MNH. KWP Dated: September 11, 2013 Received: September 13, 2013

Dear Mr. Eggleton:

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

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Page 2 - Mr. Justin Eggleton

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-204 ) or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Ering Keith

for

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known) K132412

## Device Name

Inertia(TM) MIS Pedicle Screw System

#### Indications for Use (Describe)

The Inertia™ MIS Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spinc (TI 10 S2): severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra; degenerative spondylolishesis with objective evidence of neurologic impairment; facture; spinal stenosis; scolosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Type of Use (Select one or both, as applicable) [x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

Image /page/4/Figure/11 description: The image shows a document with the heading "FOR FDA USE ONLY". Below the heading is the text "Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)". The name "Ronald P. Jean -S" is written below this text, presumably as a signature.