← Product Code [MNH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MNH) · K133690 # TRUE SPINAL FUSSION SYSTEM (K133690) _Innovative Surgical Designs · MNH · May 7, 2014 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MNH/K133690 ## Device Facts - **Applicant:** Innovative Surgical Designs - **Product Code:** [MNH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MNH.md) - **Decision Date:** May 7, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3070 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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 for spinal immobilization and stabilization. Components include longitudinal rods, polyaxial pedicle screws, and rod-to-rod connectors. Used by surgeons in clinical settings to treat spinal instabilities or deformities as an adjunct to fusion. System modifications include a new rod-to-rod connector, thermoformed instruments, and a reduced final torque value (7.5 Nm). Implants are titanium alloy; instruments are stainless steel and IXEF. Device provides mechanical support to the spine to facilitate fusion and patient recovery. ## Clinical Evidence Bench testing only. Static compression bending, torsion, 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 Rod-based pedicle screw fixation system. Implants: Titanium alloy (Ti-6Al-4V ELI, ASTM F136). Instruments: 17-4 stainless steel (ASTM F899) and Gray IXEF GY51. Final torque specification: 7.5 Nm. Mechanical performance validated via ASTM F1717 and ASTM F1798. ## Regulatory 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 - CD HORIZON® ([K031655](/device/K031655.md)/[K041460](/device/K041460.md)) - Moss® Miami ([K992168](/device/K992168.md)/[K022623](/device/K022623.md)) - Synergy™ VLS ([K950099](/device/K950099.md)/[K974749](/device/K974749.md)) - True™ ([K130958](/device/K130958.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## Section 8 - 510(k) Summary MAY 0 7 2014 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 Trade Names: True™ Spinal Fixation System Device Classification Class II Classification Name: Pedicle screw spinal system Regulation: 888.3070 Device Product Code: MNI, MNH Device Description: The True™ Spinal Fixation System consists of pairs of longitudinal members (rods), anchors (polyaxial pedicle screws) and interconnections (rod-rod connectors). The changes include a rod to rod connector for ease of delivery, thermoformed instruments to replace the stainless steel instruments, a lower final torque value of 7.5Nm previously 8.5 Nm 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, 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 Gray IXEF GY51. Predicate Devices: CD HORIZON® (K031655/K041460), Moss® Miami (K992168/K022623) and the Synergy™ VLS (K950099/K974749) and True™(K130958) Performance Data: Static compression bending and torsion, 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. {1}------------------------------------------------ Technological Characteristics: The True™ Spinal Fixation System possesses the same technological characteristics as the predicates. These include: - . 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. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 7, 2014 Innovative Surgical Designs, Incorporated Mr. Ed Morris Chief Executive Officer 2660 East 2nd Street #10 Bloomington, Indiana 47401 Re: K133690 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: April 9, 2014 Received: April 10, 2014 Dear Mr. 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 {3}------------------------------------------------ ### 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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/dcfault.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincercly vours. # Ronald P: Jean -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Section 7 - Indications for Use Statement 510(k) Number:_K133690 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, kyphosis, 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 Center for Devices and Radiological Health (CDRH) James P. Bertram -S 2014.05.06 16:48:07 -04'00' -- (Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133690 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MNH/K133690](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MNH/K133690) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com