CERTEX SPINAL IMPLANT SYSTEM

K122163 · X-Spine Systems, Inc. · MNI · Oct 31, 2012 · Orthopedic

Device Facts

• Record ID: K122163
• Device Name: CERTEX SPINAL IMPLANT SYSTEM
• Applicant: X-Spine Systems, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Oct 31, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Certex Spinal Implant System is to promote fusion of the subaxial cervical spine and cervico-thoracic junction (C3 - T3 inclusive). The indications for use are as follows: - Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), - Spondylolisthesis, - Trauma (i.e., fracture or dislocation), - Spinal Stenosis, - Failed previous fusion, - Revision of previous cervical spine surgery, - Spinal tumors. The use of screws is limited to placement in TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Device Story

Certex Spinal Implant System comprises titanium alloy screws, hooks, rods, and cross connectors used for spinal fixation and fusion. Designed for subaxial cervical spine and cervico-thoracic junction (C3-T3). Implants are provided non-sterile for single-use. Surgeons select appropriate implant sizes based on patient anatomy and pathology. System provides mechanical stabilization to promote fusion. Used in clinical settings by surgeons. Benefits include stabilization of spinal segments in patients with degenerative, traumatic, or neoplastic conditions.

Clinical Evidence

Bench testing only. Biomechanical testing performed per ASTM F1717, including static compression bending, static torsion, and dynamic compression bending, to demonstrate substantial equivalence in mechanical performance.

Technological Characteristics

Constructed from Titanium alloy per ASTM F136. Components include screws, hooks, rods, and cross connectors. Non-sterile, single-use. Mechanical stabilization via spinal construct. No software or electronic components.

Indications for Use

Indicated for patients requiring fusion of subaxial cervical spine and cervico-thoracic junction (C3-T3) due to degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, failed previous fusion, revision surgery, or spinal tumors. Screws restricted to T1-T3 for thoracic conditions; not for cervical spine placement.

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

• Aesculap, Inc. S4 Spinal System (K050979)
• Seaspine, Inc. Sierra System (K062934)
• X-spine Fortex Spinal Fixation System (K090224)

Submission Summary (Full Text)

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# 510(k) Summary

OCT 31 2012

## ADMINISTRATIVE INFORMATION

| Manufacturer Name: | X-spine Systems, Inc.<br>452 Alexandersville Rd.<br>Miamisburg, OH 45342 |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| | Telephone [phone] |
| | FAX [phone] |
| Official Contact: | David Kirschman, M.D.<br>Chief Medical Officer |
| Initial Date Prepared: | 7/19/2012 |
| DEVICE NAME | |
| Trade/Proprietary Name: | Certex™ Spinal Implant System |
| Common Name: | Spinal Implants |
| Device Class: | Class II |
| Classification Name: | MNI §888.3070 - Orthosis, Spinal Pedicle Fixation<br>KWP §888.3050 - Appliance, Fixation, Spinal Interlaminal |

# ESTABLISHMENT REGISTRATION NUMBER

The X-spine Systems, Inc. establishment registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.

# INTENDED USE

The intended use of the Certex Spinal Implant System is to promote fusion of the subaxial cervical spine and cervico-thoracic junction (C3 - T3 inclusive). The indications for use are as follows:

- Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- Spondylolisthesis, .
- . Trauma (i.e., fracture or dislocation),
- Spinal Stenosis, .
- Failed previous fusion, .
- Revision of previous cervical spine surgery, �
- Spinal tumors.

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The use of screws is limited to placement in TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

## DEVICE DESCRIPTION

The Certex Spinal Implant System consists of screws, hooks, rods, and cross connectors. Various sizes of these implants are available so that adaptations can be made to take into account pathology and individual patient anatomy. The Certex Spinal Implant System is manufactured from Titanium alloy in accordance with ASTM F136 and will be provided non-sterile. All implants are intended for single use only and should not be reused under any circumstances.

# EQUIVALENCE TO MARKETED PRODUCT

X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Certex Spinal Implant System is substantially equivalent to predicate devices based on a comparison including the following characteristics:

- FDA Product Code .
- . Intended Uses
- Surgical Approach .
- � Anatomical Region
- ◆ Implant Materials
- � Product Dimensions
- Mechanical Performance .

### PREDICATE DEVICES

- Aesculap, Inc. S4 Spinal System (K050979)
- Seaspine, Inc. Sierra System (K062934) .
- X-spine Fortex Spinal Fixation System (K090224) .

## PERFORMANCE DATA

The implant components were tested using the following standards:

ASTM F1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

- . Static Compression Bending
- Static Torsion ●
- t Dynamic Compression Bending

In conclusion, biomechanical testing results indicate that the Certex Spinal Implant System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use.

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

X-Spine Systems, Incorporated % Mr. David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342

OCT
31
2012

Re: K122163

Trade/Device Name: Certex™ Spinal Implant System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, KWP Dated: September 28, 2012 Received: October 01, 2012

Dear Mr. Kirschman:

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. David Kirschman, M.D.

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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Melkerson

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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## Indications for Use

510(k) Number (if known): K122163

Device Name: Certex™ Spinal Implant System

Indications for Use:

The intended use of the Certex Spinal Implant System is to promote fusion of the subaxial cervical spine and cervico-thoracic junction (C3 -T3 inclusive). The indications for use are as follows:

- . Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- . Spondylolisthesis,
- Trauma (i.e., fracture or dislocation), ●
- . Spinal Stenosis,
- Failed previous fusion, .
- Revision of previous cervical spine surgery, .
- . Spinal tumors.

The use of screws is limited to placement in TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

AND/OR .

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 ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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

KIZZI63 510(k) Number_