CD Horizon™ Spinal System

{0}------------------------------------------------ September 10, 2020 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. Medtronic Sofamor Danek USA, INC. Raphael Mcinnis Senior RAS Manager 1800 Pyramid Place Memphis, Tennessee 38132 Re: K201407 Trade/Device Name: CD Horizon™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ, OLO, HBE Dated: August 11, 2020 Received: August 13, 2020 Dear Raphael Mcinnis: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use K201407 Device Name CD Horizon™ Spinal System #### Indications for Use (Describe) The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, the CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below. When used for posterior non-cervical pedicle screw fixation in pediatic patients, the CD Horizon™ System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach. The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (1.2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use. The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor. In order to achieve additional levels of fixation, the CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use Type of Use (Select one or both, as applicable) | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |-----------------------------------------------------------------------|----------------------------------------------------------------------| |-----------------------------------------------------------------------|----------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K201407 Device Name Medtronic Navigated Reusable Instruments for use with Station™ and IPC™ Indications for Use (Describe) Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC™ POWEREASE™ System. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | 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." {5}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K201407 Device Name Medtronic Reusable Instruments Compatible with the IPC® POWEREASE® System Indications for Use (Describe) IPC® System is indicated for the incision/cuting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. The IPC® POWEREASE® System is indicated for drilling, tapping and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods. Type of Use (Select one or both, as applicable) | 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." {6}------------------------------------------------ # 510(k) SUMMARY # MEDTRONIC CD Horizon™ Spinal System # September 2020 | Submitter: | Medtronic Sofamor Danek, USA Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: (901) 396-3133<br>Fax: (901) 346-9738 | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Usman Rashid<br>Senior Regulatory Affairs Specialist<br>Telephone: (901) 396-3133 | | Date Prepared | September 10, 2020 | | Name of Device | CD Horizon™ Spinal System | | Common Name | Bone Screws | | Classification Name | Implants: NKB, KWQ, KWP<br>Instruments: OLO, HBE | | Classification | Class II (Implants)<br>Class II (Instruments/Accessories) | | Product Codes | NKB, KWQ, KWP (Implants)<br>21 CFR 888.3070 – Thoracolumbosacral pedicle screw system<br>21 CFR 888.3060 – Spinal intervertebral body fixation orthosis<br>21 CFR 888.3050 – Spinal interlaminal fixation orthosis<br>OLO (Navigated Instruments)<br>21 CFR 882.4560 – Stereotaxic instrument<br>HBE (IPC™ POWEREASE™ Compatible Instruments)<br>21 CFR 882.4310 – Powered simple cranial drills, burrs, trephines, and their accessories | | Predicate Devices | There are 6 Predicates.<br>CD Horizon™ Spinal System<br>Primary Predicate 1- K113174, S.E. 11/21/2011<br>Predicate 2- K130646, S.E. 04/10/2013<br>Predicate 3- K170679, S.E. 05/1/2017 | | | IPCTM POWEREASE™System<br>Predicate 4- K111520, S.E. 10/26/2011<br>Predicate 5- K123270, S.E. 01/11/2013<br>Medtronic Navigated Screw driver and driver sleeves<br>Predicate 6- K140454, S.E. 05/22/2014<br>The predicates have not been subject to a design related recall. | | Description of Devices | CD Horizon™ Spinal System<br>The CD Horizon™ Spinal System consists of a variety of shapes<br>and size of rods, hooks, screws, CROSSLINK(R) Plates, staples,<br>and connecting components, and well as implant components from<br>other Medtronic spinal systems, which can be rigidly locked into a<br>variety of configurations, with each construct being tailor-made<br>for the individual case. The subject CD Horizon™ Modular<br>5.5/6.0 Spinal System devices consisting of implants, instruments<br>and cases and trays to include:<br>1. Modular Screws consisting of:<br>Modular Screw Shanks (bone screws) Modular Screw Heads Modular Universal Set Screw 2. Instruments compatible with IPCTM POWEREASE™ System<br>3. Navigated Driver and Sleeves compatible with<br>STEALTHSTATION ™ and IPCTM POWEREASE™ Systems<br>4. Cases and trays | | Indications for Use | CD HORIZON™ Spinal System<br>The CD Horizon™ Spinal System with or without Sextant™<br>instrumentation is intended for posterior, non-cervical fixation as<br>an adjunct to fusion for the following indications: degenerative disc<br>disease (DDD - defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic<br>studies), spondylolisthesis, trauma (i.e. fracture or dislocation),<br>spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis),<br>tumor, pseudarthrosis, and/or failed previous fusion.<br>Except for hooks, when used as an anterolateral thoracic/lumbar<br>system, the CD Horizon™ Spinal System titanium, cobalt chrome,<br>and stainless steel implants may also be used for the same<br>indications as an adjunct to fusion. | {7}------------------------------------------------ {8}------------------------------------------------ With the exception of DDD, the CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use. The CD Horizon™ Spire™ plate is a posterior, single-level, nonpedicle supplemental fixation device intended for use in the noncervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDDD (as previously defined), spondylolisthesis, trauma, and/or tumor. In order to achieve additional levels of fixation, the CD Horizon™ Spinal System rods may be connected to the VertexTM Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use. Medtronic Reusable Instruments Compatible with the IPCTM POWEREASE™ System {9}------------------------------------------------ 1 | | IPCT™ System is indicated for the incision/cutting, removal, drilling<br>and sawing of soft and hard tissue and bone, and biomaterials in<br>Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic,<br>Spinal, Sternotomy, and General surgical procedures. | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The IPCT™ POWEREASE™ System is indicated for drilling,<br>tapping and driving screws and working end attachments during<br>spinal surgery, including open and minimally invasive procedures.<br>It is also used in placement or cutting of screws, posts and rods. | | | Medtronic Reusable Instruments Compatible with the<br>StealthStation™ System and IPC™ POWEREASE™ System | | | Medtronic Navigated Reusable Instruments are intended to be used<br>during the preparation and placement of Medtronic screws during<br>spinal surgery to assist the surgeon in precisely locating<br>anatomical structures in either open, or minimally invasive,<br>procedures.<br>Medtronic Navigated Reusable Instruments are specifically<br>designed for use with the StealthStation™ System, which is<br>indicated for any medical condition in which the use of stereotactic<br>surgery may be appropriate, and where reference to a rigid<br>anatomical structure, such as a skull, a long bone, or vertebra can<br>be identified relative to a CT or MR-based model, fluoroscopy<br>images, or digitized landmarks of the anatomy.<br>Medtronic Navigated Reusable Instruments are also compatible<br>with the IPCT™ POWEREASE™ System. | | Comparison of<br>Technological<br>Characteristics with the<br>Predicate Devices | CD Horizon™ Spinal System<br>The primary predicate for the CD Horizon™ Spinal System is the<br>predicate CD Horizon™ Spinal System (K113174, S.E.<br>11/21/2011). | | | The subject CD Horizon™ Spinal System devices have the same<br>indications, intended use, and materials as the following FDA<br>cleared predicates: Primary Predicate 1- K113174, S.E.<br>11/21/2011; Predicate 2- K130646, S.E. 04/10/2013; Predicate 3-<br>K170679, S.E. 05/1/2017 | | Medtronic Reusable Instruments for Use with the IPC™<br>POWEREASE™ System | | | The subject breakoff driver adapter and counter torque are<br>identical in intended use and material as their predicates in<br>Predicate 4- K111520, S.E. 10/26/2011; Predicate 5- K123270,<br>S.E. 01/11/2013 | | | Medtronic Navigated Reusable Instruments for Use with<br>STEALTHSTATION® System and IPC™ POWEREASE™<br>Systems | | | The subject navigated driver and driver sleeves that are<br>compatible with the STEALTHSTATION® System and IPCTM<br>POWEREASE™ Systems are identical to its predicate K140454,<br>S.E. 05/22/2014) in intended use and materials. | | | The following performance data were provided in support of<br>substantial equivalence. | | | Mechanical Testing | | | In accordance with the Guidance for Industry and FDA Staff –<br>Spinal System 510(k)'s, Medtronic has evaluated the subject<br>devices to demonstrate substantial equivalence to the predicate<br>devices. | | | The tests were performed in accordance with ASTM F1717,<br>Standard Test Methods for Spinal Implant Constructs in a<br>Vertebrectomy Model, and ASTM F1798, Standard Guide for<br>Evaluating the Static and Fatigue Properties of Interconnection<br>Mechanisms and Sub-assemblies Used in Spinal Arthrodesis<br>Implants. | | | Performance Data | For the subject instruments compatible with<br>STEALTHSTATION® System and IPC™ POWEREASE™<br>Systems, software verification testing and activities were<br>performed that demonstrated that the subject instruments<br>performed as intended. | | | | | Conclusion | Based on the test results and additional supporting information<br>provided in this premarket notification, Medtronic believes the<br>subject devices are at least as safe as and effective as the legally<br>marketed predicate devices | | | | {10}------------------------------------------------