← Product Code [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP) · K133288 # CASPIAN OCT SPINAL SYSTEM (K133288) _K2m, Inc. · KWP · Jul 1, 2014 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K133288 ## Device Facts - **Applicant:** K2m, Inc. - **Product Code:** [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP.md) - **Decision Date:** Jul 1, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3050 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The CASPIAN OCT / MESA Mini / DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) Spondylolisthesis Spinal stenosis Fracture/dislocation Revision of previous cervical spine surgery Tumors Atlantoaxial fracture with instability Occipitocervical dislocation The occipital bone screws are limited to occipital fixation only. The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine. The CASPIAN OCT / MESA Mini / DENALI Mini System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods. ## Device Story Caspian OCT Spinal System is a top-loading, posterior spinal fixation system; provides immobilization of cervical and thoracic spine as adjunct to fusion. System components include rods, hooks, and occipital anchors. Used in clinical settings by surgeons; implanted to stabilize spine. Mechanical performance validated via static compression, static torsion, and dynamic compression testing per ASTM F2706; biomechanical cadaver testing performed. Benefits include spinal stabilization for degenerative, traumatic, or neoplastic conditions. ## Clinical Evidence No clinical data. Evidence consists of bench testing (static compression, static torsion, dynamic compression per ASTM F2706) and biomechanical cadaver testing comparing subject device to predicate constructs. ## Technological Characteristics Top-loading posterior spinal fixation system. Materials: Ti6Al4V ELI per ASTM and ISO standards. Components: occipital anchors, rods, hooks, pedicle screws. Connectivity: linkable to Range Spinal System via 3.5mm/5.5mm connectors. Mechanical testing per ASTM F2706. ## Regulatory Identification A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome. ## Predicate Devices - K2M Caspian OCT Spinal System ([K101084](/device/K101084.md)) - Medtronic Vertex ([K052402](/device/K052402.md)) ## Reference Devices - Range Spinal System ## 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}------------------------------------------------ ## 510(k) Summary for the Caspian OCT Spinal System This 510(k) summary for the Caspian OCT Spinal System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act. 1. Submitter : K2M, Inc. 751 Miller Drive SE. Suite FI Leesburg, VA 20175 Contact Person : Nancy Giezen K2M. Inc. Telephone: 703-777-3155 Date Prepared: 10/24/13 - 2. Tradename: Common Name: Classification Name: Regulatory Class: Device Product Code: Caspian OCT Spinal System Spinal Fixation System Spinal Interlaminal Fixation Orthosis (21CFR 888.3050) KWP Class II #### 3. Predicate or legally marketed devices which are substantially equivalent : - K2M Caspian OCT Spinal System (K101084) . - Medtronic Vertex (K052402) t #### 4. Description of the device: The Caspian OCT Spinal System is a top-loading, multiple component, posterior (occipital-cervicalthoracic) spinal fixation system. The purpose of this submission is to add the Occipital Anchor to the system. Materials: The subject devices are manufactured from Ti6A14V Eli per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization of the posterior cervical and thoracic spine. #### 5. Intended Use: The CASPIAN OCT / MESA Mini / DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following: - 해 DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) - . Spondylolisthesis - . Spinal stenosis - � Fracture/dislocation - . Revision of previous cervical spine surgery - . Tumors - � Atlantoaxial fracture with instability - t Occipitocervical dislocation The occipital bone screws are limited to occipital fixation only. K133288 Page 1 of 2 {1}------------------------------------------------ The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine. The CASPIAN OCT / MESA Mini / DENALI Mini System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods. 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices : The subject components were mechanically tested and performed equally to or better than the original Caspian OCT Spinal constructs in static compression, static torsion and dynamic compression in accordance with ASTM F2706. The constructs were also compared in biomechanical (cadaver) testing and the devices were found to perform substantially the same. There are no significant differences between the Caspian 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. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. ) ### 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 July 1, 2014 K2M, Incorporated Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive SE, Suite Fl Leesburg, Virginia 20175 Re: K133288 Trade/Device Name: Caspian OCT Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: May 30, 2014 Received: June 2, 2014 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {3}------------------------------------------------ Page 2 - Ms. Nancy Giezen 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/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 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 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 {4}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. ## 510(k) Number (if known) K133288 Device Name Caspian OCT Spinal System ## Indications for Use (Describe) The CASPIAN OCT/MESA Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervical-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following: - DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies): - -Spondylolisthesis; - -Spinal stenosis: - -Fracture/dislocation; - -Revision of previous cervical spine surgery; - -Tumors: - -Atlantoaxial fracture with instability; - -Occipitocervical dislocation The occipital bone screws are limited to occipital fixation only. The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended in or treat conditions involving the cervical spine. The CASPIAN OCT/MESA Mini System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) ## Division of Offhopedic Devices {5}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. 1 ## *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." "," . --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K133288](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K133288) **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. 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