YUKON OCT Spinal System

K171444 · K2m, Inc. · NKG · Aug 8, 2017 · Orthopedic

Device Facts

Record IDK171444
Device NameYUKON OCT Spinal System
ApplicantK2m, Inc.
Product CodeNKG · Orthopedic
Decision DateAug 8, 2017
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3075
Device ClassClass 2
AttributesTherapeutic

Intended Use

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 (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 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.

Device Story

Posterior spinal fixation system; components include screws, hooks, rods, rod connectors, and occipital components. Used for immobilization and stabilization of craniocervical, cervical, and thoracic spinal segments. Operates as mechanical adjunct to fusion; provides structural support for spinal column. Designed for attachment to multiple rod sizes (3.5mm/4.0mm) and compatible with EVEREST Spinal System via transition rods. Used by surgeons in clinical/OR settings. Provides rigid fixation to address fractures, deformities, tumors, and degenerative conditions; benefits patients by restoring spinal integrity and facilitating fusion or providing palliative stability.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F1717 and F2706, including static torsion, static compression, dynamic torsion, and dynamic compression, to demonstrate substantial equivalence.

Technological Characteristics

Top-loading posterior spinal fixation system. Components: screws, hooks, rods, rod connectors, occipital components. Materials: standard orthopedic implant materials. Connectivity: mechanical, compatible with EVEREST Spinal System. Testing standards: ASTM F1717, ASTM F2706.

Indications for Use

Indicated for patients with acute/chronic instabilities of craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3) requiring immobilization/stabilization as an adjunct to fusion. Conditions include traumatic fractures/dislocations, instability/deformity, failed fusions, cervical tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for palliative stabilization in patients with advanced cervical tumors where fusion is not expected.

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}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 K2M, Inc. Ms. Nancy Giezen Manager, Regulatory Affairs 600 Hope Parkway SE Leesburg, Virginia 20175 August 8, 2017 Re: K171444 Trade/Device Name: YUKON OCT Spinal System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: May 15, 2017 Received: May 16, 2017 Dear Ms. Giezen: 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in Image /page/0/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other. The faces are connected by a flowing line that resembles a ribbon. {1}------------------------------------------------ the quality systems (OS) 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/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 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. Sincerely, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Food and Drug Administration | | | <b>Indications for Use</b> | | | Form Approved: OMB No. 0910-0120 | | | Expiration Date: January 31, 2017 | | | See PRA Statement below. | | | 510(k) Number (if known) | K171444 | | Device Name | YUKON OCT Spinal System | | Indications for Use (Describe) | 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 (CI 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 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) | | | | <label><input checked="checked" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</label> | | | <label><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</label> | 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](mailto: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 FDA 3881 (8/14) | Page 1 of 1 | |----------------------|-------------| |----------------------|-------------| {3}------------------------------------------------ ## 510(k) SUMMARY YUKON OCT Spinal System #### Submitter K2M, Inc. 600 Hope Parkway SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: 571-919-2000 Date Prepared: 7/19/2017 ## Classification | Trade Name: | YUKON OCT Spinal System | |-------------------|------------------------------------| | Common Name: | Spinal Fixation System | | Regulatory Class: | Unclassified (NKG), Class II (KWP) | ## Classification Name(s): Orthosis, cervical pedicle screw spinal fixation (Unclassified, Product Code NKG) Appliance, fixation, spinal interlaminal (21 CFR 888.3050, Product Code KWP) ## Predicate Device(s) Primary Predicate: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (081107) Additional Predicates: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K101084, K153370) DePuy Mountaineer (K042508, K110353) Zimmer Virage (K133556) Biomet Lineum (K151224) Synthes Synapse (K142838) Occipital Rod/Plate, CerviFix (K982322, K984377) Medtronic Vertex (K052402, K083071) Reference Devices: K2M Everest Spinal System (K161369) K2M Range/Mesa/Denali (K141147) #### Device Description The YUKON OCT Spinal System is a top-loading, multiple component, posterior (occipitalcervical-thoracic) spinal fixation system consisting of screws, hooks, rods, rod connectors, and occipital components. Function: The system functions as an adjunct to fusion to provide stabilization of the posterior cervical and thoracic spine. {4}------------------------------------------------ #### Indications for Use 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 (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 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. ## Technological Comparison to Predicate(s) The subject implants were compared to predicate systems and the design features, materials and sizes were found to be substantially the same as these systems. The method of attachment to the posterior spine is also the same as the predicate devices. However each of the YUKON implants are designed to attach to multiple rod sizes (similar to the K2M EVEREST Spinal System). Pedicle screws, hooks and transverse connectors attach to 3.5mm or 4.0mm diameter rods while the 3.5mm/4.0mm rod to rod connectors can link to rod diameters of 5.5mm or 6.0mm. #### Non-clinical Performance Evaluation Published literature and mechanical testing per ASTM F1717 and F2706 (static torsion, static compression, dynamic torsion, dynamic compression) revealed that the YUKON OCT Spinal System is substantially equivalent to the predicate devices. #### Conclusion There are no significant differences between the YUKON OCT Spinal System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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