# K221244: CD Horizon™ Spinal System - Pathway: 510(k) (Special) - Applicant: Medtronic - Decided: May 25, 2022 after 23 days - Product code: NKB (Thoracolumbosacral Pedicle Screw System) - Device class: 2 - Regulation: 21 CFR 888.3070 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 22 generations back to K040583 (2004). 325 ancestors in all. 20 later devices descend from it; 7 cite it directly. 0 of 346 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K210637: CD Horizon™ Spinal System, Medtronic (2021) Summary page 8. - K201407: CD Horizon™ Spinal System, Medtronic Sofamor Danek USA, Inc. (2020) Summary page 8. - K042025: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2004) Summary page 8. - K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 8. - K141604: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 8. - K091974: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2009) Summary page 8. - K132471: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 8. - K150178: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 8. - K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 8. - K153442: CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 8. ## Most influential descendants - K223494: CD Horizon Spinal System (2023), 17 descendants of its own - K233951: CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) (2024), 5 descendants of its own - K233508: iFuse Bedrock Granite® Implant System (2024), 5 descendants of its own - K243007: CD Horizon™ Spinal System (2024), 3 descendants of its own - K253802: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 1 descendant of its own ## Indications for use 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, kyphosis, 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, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted. When used for posterior non-cervical pedicle screw fixation in pediatric patients, 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. Devices are 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, spondylolisthesis, trauma, and/or tumor. To achieve additional levels of fixation, 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 Vertex™ indications. 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. Do not implant the instruments. The IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. The IPC™ Powerease™ System is indicated for drilling, tapping, and driving screws 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. Do not implant instruments. Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems. Navigated surgical 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. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments. Do not implant the instruments. Source page: https://510kreport.com/device/K221244 Methodology: https://510kreport.com/methodology