TRUE SPINAL FIXATION SYSTEM

K130958 · Innovative Surgical Designs · MNI · Oct 17, 2013 · Orthopedic

Device Facts

• Record ID: K130958
• Device Name: TRUE SPINAL FIXATION SYSTEM
• Applicant: Innovative Surgical Designs
• Product Code: MNI · Orthopedic
• Decision Date: Oct 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The True™ Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for 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, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

Device Story

True™ Spinal Fixation System is a posterior, noncervical pedicle screw system; consists of longitudinal rods, polyaxial pedicle screws, and rod-rod connectors. Used in thoracic, lumbar, and sacral spine (T1-S1) to provide immobilization and stabilization as an adjunct to fusion. Requires dual-rod configuration per connector. Implants manufactured from titanium alloy (Ti-6Al-4V ELI). Used by surgeons in clinical/OR settings to treat spinal instabilities or deformities. Provides mechanical stabilization to facilitate bone fusion; benefits patients by addressing acute/chronic spinal conditions.

Clinical Evidence

Bench testing only. Static and dynamic compression bending tests were performed on the worst-case construct according to ASTM F1717 and ASTM F1798 standards. Results demonstrate performance is substantially equivalent to predicate devices.

Technological Characteristics

System components: longitudinal rods, polyaxial pedicle screws, rod-rod connectors. Materials: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 for implants; 17-4 stainless steel (ASTM F899) and IXEF PARA GS-1022 for instruments. Mechanical fixation principle. Dual-rod configuration required.

Indications for Use

Indicated for skeletally mature patients requiring posterior, noncervical (T1-S1) pedicle fixation as an adjunct to fusion for acute/chronic spinal instabilities or deformities including severe spondylolisthesis (grades 3-4, L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion.

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

• HORIZON® (K031655/K041460)
• Moss® Miami (K992168/K022623)
• Synergy™ VLS (K950099/K974749)

Submission Summary (Full Text)

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### Section 8 - 510(k) Summary

Date: 11 October 2013

Sponsor: Innovative Surgical Designs, Inc. 2660 E. 2nd Street #10 Bloomington, IN 47401 Phone: 812:322.8265 Facsimile: 812.720.9879

Contact Person: Ed Morris, CEO

OCT 1 7 2013

Trade Names: True™ Spinal Fixation System

Device Classification Class II

Classification Name: Pedicle screw spinal system

Requiation: 888.3070

Device Product Code: MNI, MNH

Device Description: The True™ Spinal Fixation System consists of pairs of longitudinal members (rods), anchors (polyaxial pedide screws) and interconnections (rod-rod connectors). These are available in a variety of sizes to accommodate differing patient anatomy. Dual Rod use Only. The True™ Spinal Fixation System is intended to be used only as a dual rod system and must be used with two rods per connector in all cases. Do not use one rod per connector.

Intended Use: The True™ Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedice fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for 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, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

Materials: True™ Spinal Fixation System implants are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. True™ Spinal Fixation System instruments are manufactured from 17-4 stainless steel ASTM F899 and IXEF PARA GS-1022.

HORIZON® - (K031655/K041460), Moss® Miami Predicate Devices: CD (K992168/K022623) and the Synergy™ VLS (K950099/K974749)

Performance Data: Static compression bending and dynamic compression bending tests were performed according to ASTM F1717 and ASTM 1798 on the worst case True™ construct. The mechanical test results demonstrate that the True™ Spinal Fixation System performance is substantially equivalent to the predicate devices.

Technological Characteristics: The True™ Spinal Fixation System possesses the same technological characteristics as the predicates. These include:

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- basic design (rod-based pedicle screw fixation system), .
- material (titanium alloy) and .
- anatomic location. .

Technological characteristics which are different have been supported with descriptive information and/or performance data which demonstrate the safety and effectiveness has not been diminished.

Conclusion: In comparison to the predicate devices, the True™ Spinal Fixation System has

- the same intended use (as described above), .
- the same technological characteristics or different without raising safety and . effectiveness issues (as described above)

Therefore the True™ Spinal Fixation System can be found substantially equivalent to the predicate devices.

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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 17, 2013

Innovative Surgical Designs, Incorporated Mr. Ed Morris CEO 2660 East 2nd Street #10 Bloomington, Indiana 47401

Re: K130958

Trade/Device Name: TRUE™ Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: September 17, 2013 Received: September 19, 2013

Dear Mr. Morris:

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. Ed Morris

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 Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] 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/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.

## Ronald P. Jean -S for

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 Statement

510(k) Number: K130958

Device Name: True™ Spinal Fixation System

Indications for Use:

The True™ Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for 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, spinal stenosis, scoliosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

> OR Over-the-Counter Use Prescription Use x (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

# Ronald®ªJean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130958