EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System

K181603 · K2m, Inc. · NKG · Oct 5, 2018 · Orthopedic

Device Facts

Record IDK181603
Device NameEVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
ApplicantK2m, Inc.
Product CodeNKG · Orthopedic
Decision DateOct 5, 2018
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3075
Device ClassClass 2
AttributesTherapeutic, Pediatric

Intended Use

The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications: Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Story

Top-loading, multi-component posterior spinal fixation system; includes pedicle screws, hooks, rods, and connectors. Used in spinal fusion procedures to provide immobilization and stabilization of spinal segments. Operated by surgeons in clinical/OR settings. Implants manufactured from titanium alloy (ASTM F136, F1472), titanium (ASTM F67), and cobalt chrome (ASTM F1537). Submission establishes MR Conditional labeling claim and adds sterile packaging options for CASPIAN components. No changes to fundamental scientific technology or design compared to predicate devices.

Clinical Evidence

Bench testing only. MR compatibility testing performed per ASTM F2503 to support MR Conditional labeling claim. No clinical data provided.

Technological Characteristics

Top-loading posterior spinal fixation system. Materials: Titanium alloy (ASTM F136, ASTM F1472), titanium (ASTM F67), cobalt chrome (ASTM F1537). Instruments include stainless steel, aluminum, linen phenolic, Ultem, Radel, polypropylene, acetal copolymer, silicone. MR Conditional.

Indications for Use

Indicated for posterior non-cervical fixation as an adjunct to fusion in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or failed previous fusion. Also indicated for anterolateral thoracic/lumbar fixation (excluding hooks). Pediatric indication for adolescent idiopathic scoliosis using posterior pedicle screw fixation with autograft/allograft. Additional indications for craniocervical, cervical (C1-C7), and thoracic (T1-T3) stabilization for trauma, instability, deformity, failed fusion, tumors, and degenerative disease (radiculopathy/myelopathy).

Regulatory Classification

Identification

Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Special Controls

*Classification.* Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant. (3) Device components must be demonstrated to be biocompatible. (4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (5) Labeling must include the following: (i) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (ii) Intended use and indications for use including levels of fixation; (iii) Device specific warnings, precautions, and contraindications that include the following statements: (A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies ( *e.g.,* CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.” (iv) Identification of magnetic resonance (MR) compatibility status; (v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and; (vi) Detailed instructions of each surgical step, including device removal.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. October 5, 2018 K2M Inc. % Karen E. Warden, Ph.D. President BackRoads Consulting, Inc. P.O. Box 566 Chesterland, Ohio 44026 Re: K181603 Trade/Device Name: EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System Regulatory Class: Unclassified Product Code: NKG, NKB, KWP, KWO Dated: June 18, 2018 Received: June 19, 2018 Dear Dr. Warden: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Ronald P. Jean -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) ## K181603 Device Name EVEREST Spinal System #### Indications for Use (Describe) The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications: Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion. When used for posterior non-cervical pediale screw fixation in pediatric patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ### 510(k) Number (if known) K181603 Device Name RANGE (MESA and DENALI) Spinal System ### Indications for Use (Describe) Range (Mesa and Denali) and ARI are cleared for the following indications: Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion. Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | <span> <b> X Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> | <span> <b> Over-The-Counter Use (21 CFR 801 Subpart C) </b> </span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # Indications for Use # 510(k) Number (if known) # K181603 ## Device Name Caspian OCT (MESA Mini and DENALI Mini) Spinal System ### Indications for Use (Describe) The Caspian OCT/MESA Mini Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction. the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Caspian OCT/MESA Mini/DENALI Mini Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Caspian OCT/MESA Mini/DENALI Mini Spinal System may be connected to RangeMESA/DENALI Spinal System and Everest Spinal System components via the rod to rod connectors or transition rods. | Type of Use ( <i>Select one or both, as applicable</i> ) | | |----------------------------------------------------------|--| |----------------------------------------------------------|--| X | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {5}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ### 510(k) Number (if known) K181603 Device Name YUKON OCT Spinal System ### Indications for Use (Describe) The YUKON OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The YUKON OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the YUKON OCT Spinal System may be connected to Everest Spinal System components via the rod to rod connectors or transition rods | Type of Use (Select one or both, as applicable) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="text-decoration: line-through;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {6}------------------------------------------------ | Date: | 18 June 2018 | |---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | K2M Inc.<br>600 Hope Pkwy. SE<br>Leesburg, Virginia 20175<br>Phone: 571.919.2000 | | Sponsor Contact: | Nancy Giezen | | 510(k) Contact: | Karen E. Warden, PhD<br>BackRoads Consulting<br>PO Box 566<br>Chesterland, OH 44026<br>Office: 440.729.8457 | | Trade Names: | EVEREST, RANGE (MESA and DENALI), CASPIAN OCT (MESA Mini and<br>DENALI Mini) and YUKON OCT Spinal Systems | | Common Name: | Spinal Fixation Systems | | Regulatory Class: | Class II | | Classification Names,<br>Regulations, Product<br>Codes: | Appliance, fixation, spinal interlaminal, 888.3050, KWP<br>Appliance, fixation, spinal intervertebral body, 888.3060, KWQ<br>Thoracolumbosacral pedicle screw system, 888.3070, NKB<br>Orthosis, cervical pedicle screw spinal fixation, unclassified, NKG | | Device Description: | The previously cleared K2M EVEREST, RANGE (MESA and DENALI),<br>CASPIAN OCT (MESA Mini and DENALI mini) and YUKON OCT Spinal<br>Systems are top-loading, multiple component posterior spinal fixation<br>implants consisting of pedicle screws, hooks, rods and connectors, intended<br>to provide support during spinal fusion procedures.<br>The primary purpose of this submission is to establish an MR Conditional<br>labeling claim for these implants. In addition, CASPIAN components that<br>were previously provided non-sterile are now being optionally offered as<br>sterile packaged devices. | | Indications for Use: | EVEREST® Spinal System:<br>The EVEREST® Spinal System may be used in conjunction with the<br>RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared<br>for the following indications:<br>Posterior non-cervical fixation as an adjunct to fusion for the following<br>indications: degenerative disc disease (defined as back pain of<br>discogenic origin with degeneration of the disc confirmed by history<br>and radiographic studies); spondylolisthesis; trauma (i.e., fracture or<br>dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or<br>lordosis); tumor; pseudarthrosis; and/or failed previous fusion.<br>Except for hooks. when used as an anterolateral thoracic/lumbar system<br>the EVEREST® Spinal System may also be used for the same indications<br>as an adjunct to fusion.<br>When used for posterior non-cervical pedicle screw fixation in pediatric<br>patients the EVEREST® Spinal System implants are indicated as an<br>adjunct to fusion to treat adolescent idiopathic scoliosis. These<br>devices are to be used with autograft and/or allograft. Pediatric pedicle<br>screw fixation is limited to a posterior approach.<br>RANGE® (MESA® and DENALI®) Spinal System:<br>Range (Mesa and Denali) and ARI are cleared for the following indications:<br>Posterior non-cervical fixation as an adjunct to fusion for the following | # 510(k) Summary {7}------------------------------------------------ indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis: trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion. Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach CASPIAN OCT (MESA Mini and DENALI mini) Spinal System: The Caspian OCT/MESA Mini/DENALI Mini Spinal System is intended to provide immobilization and stabilization of spinal seqments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Caspian OCT/MESA Mini/DENALI Mini Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Caspian OCT/MESA Mini/DENALI Mini Spinal System may be connected to Range/MESA/DENALI Spinal System and Everest Spinal System components via the rod to rod connectors or transition rods. YUKON OCT Spinal System: The YUKON OCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations: instability or deformity: failed previous fusions (e.q., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The YUKON OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the YUKON OCT Spinal System may be connected to Everest Spinal System components via the rod to rod connectors or transition rods. The EVEREST, RANGE (MESA and DENALI), CASPIAN OCT (MESA Mini and DENALI Mini) and YUKON OCT Spinal Systems are manufactured from titanium alloy (ASTM F136 and ASTM F1472), titanium (ASTM F67) Materials: and cobalt chrome (ASTM F1537). The materials used in the manufacturing of the instruments are stainless steel with some of the instruments {8}------------------------------------------------ | | incorporating aluminum, linen phenolic, Ultem, Radel, polypropelene, acetal<br>copolymer, or silicone in the handles or retractor blades | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Predicate: | EVEREST Spinal System (K2M Inc. – K181188) | | Additional Predicates: | RANGE (MESA and DENALI) Spinal System (K2M Inc. – K171832),<br>CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System (K2M Inc. –<br>K153370), YUKON OCT Spinal System (K2M Inc. – K171444) | | Reference Devices: | Vertex™ Reconstruction System (Medtronic Sofamor Danek USA, Inc. –<br>K180851), Magec® System (NuVasive Specialized Orthopedics- K171791) | | Performance Data: | MR Compatibility testing per ASTM F2503 was performed. The test results<br>demonstrate that the EVEREST, RANGE (MESA and DENALI), CASPIAN<br>OCT (MESA Mini and DENALI Mini) and YUKON OCT Spinal Systems<br>performance is substantially equivalent to the predicate devices. | | Technological<br>Characteristics: | The EVEREST, RANGE (MESA and DENALI), CASPIAN OCT (MESA Mini<br>and DENALI Mini) and YUKON OCT Spinal Systems possess the same<br>technological characteristics as their predicate devices; no changes have<br>been made to any of the devices. Therefore the fundamental scientific<br>technology of the EVEREST, RANGE (MESA and DENALI), CASPIAN OCT<br>(MESA Mini and DENALI Mini) and YUKON OCT Spinal Systems is the<br>same as previously cleared devices. | | Conclusion: | The EVEREST, RANGE (MESA and DENALI), CASPIAN OCT (MESA Mini<br>and DENALI Mini) and YUKON OCT Spinal Systems possess the same<br>intended use and technological characteristics as the predicate devices.<br>Therefore the EVEREST, RANGE (MESA and DENALI), CASPIAN OCT<br>(MESA Mini and DENALI Mini) and YUKON OCT Spinal Systems are<br>substantially equivalent. |
Innolitics
510(k) Summary
Decision Summary
Classification Order
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