TIGER SPINE SYSTEM

K120696 · Corelink, LLC · MNI · Apr 2, 2012 · Orthopedic

Device Facts

Record IDK120696
Device NameTIGER SPINE SYSTEM
ApplicantCorelink, LLC
Product CodeMNI · Orthopedic
Decision DateApr 2, 2012
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3070
Device ClassClass 2
AttributesTherapeutic

Intended Use

The TIGER™ Spine 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as a pedicle screw system, the TIGER™ is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Device Story

Tiger™ Spine System; spinal fixation hardware including rods, connectors, and pedicle screws. Used for single or multiple level spinal stabilization. Implanted by surgeons in clinical/OR settings to treat spinal deformities or instabilities. Provides mechanical support to facilitate fusion. Output is physical stabilization of spinal segments. Benefits patient by correcting alignment and promoting fusion in severe spinal pathologies.

Clinical Evidence

No clinical studies were performed. Evidence is based on non-clinical bench testing (static/dynamic compression and static torsion per ASTM F1717).

Technological Characteristics

Spinal pedicle fixation system consisting of rods, connectors, and screws. Mechanical testing performed per ASTM F1717. No software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions: degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudarthrosis. Pedicle screw use indicated for severe Grade 3-4 spondylolisthesis (L5-S1) with autogenous bone graft (L3-sacrum).

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K120696 Page 1 of 2 ## Special 510(k) Summary for the Tiger™ Spine System APR - 2 2012 In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following Special 510(k) summary is submitted for the Tiger™ Spine System #### 1. GENERAL INFORMATION | Date Prepared: | February 29, 2012 | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name: | TIGER™ Spine System | | Common Name: | pedicle screw system | | Classification Name: | orthosis, spinal pedicle fixation<br>orthosis, spondylolisthesis spinal fixation | | Class: | II | | Product Code: | MNI<br>MNH | | CFR section: | 21 CFR section 888.3070 | | Device panel: | Orthopedic | | Legally Marketed | TIGER™ Spine System (K110321) | | Predicate Device: | Viper™ Spine System (K061520/K111571)<br>Synergy VLS - open (K000236)<br>DePuy Spine - Moss Miami SS (K950697)<br>DePuy Spine - Moss Miami (K955348)<br>Viper - DePuy (K061520/K111571)<br>Click'X - Synthes (K992739)<br>Pangea - Synthes (K052123) | | Submitter: | Corelink, LLC<br>10805 Sunset Office Drive, Suite 300<br>St. Louis, MO 63127 | | Contact: | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199<br>e-mail: jdwebb@orthomedix.net | ### 2. DEVICE DESCRIPTION The TIGER™ Spine System is composed of rods, connectors, and pedicle screws. It can be used for single or multiple level fixations. ## Change from Predicate: The purpose of this submission is to make modifications/additions to the components of the TIGER™ Spine System cleared in K110321. The standard construct is modified by the addition of a variety of additional/modified screws and rods. # 3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES {1}------------------------------------------------ The TIGER™ Spine System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances. #### 4. INTENDED USE The TIGER™ Spine 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as a pedicle screw system, the TIGER™ is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. #### 5. NON-CLINICAL TEST SUMMARY The following tests were conducted: - Static and dynamic compression per ASTM F1717 . - Static torsion per ASTM F1717 . The results of this testing indicate that the TIGER™ is equivalent to predicate device(s). #### 6. CLINICAL TEST SUMMARY No clinical studies were performed ### 7. CONCLUSIONS NONCLINICAL AND CLINICAL This summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the TIGER™ System is as safe, as effective, and performs as well or as better than the predicate device(s). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Corelink, LLC % The OrthoMedix Group, Incorporated Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681 APR - 2 2012 Re: K120696 Trade/Device Name: Tiger™ Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: February 29, 2012 Received: March 7, 2012 Dear Mr. Webb: 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. J.D. Webb 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## INDICATIONS FOR USE 510(k) Number (if known): K120696 Device Name: TIGER " Spine System #### Indications for Use: The TIGER"" Spine System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as a pedicle screw system, the TIGER™ Spine System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices KI 20696 510(k) Number_
Innolitics
510(k) Summary
Decision Summary
Classification Order
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