# K172275: Vitality® Spinal Fixation System, Vitality®+ Power Instrument System - Pathway: 510(k) (Traditional) - Applicant: Zimmer Biomet Spine, Inc. - Decided: Sep 27, 2017 after 61 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: 19 generations back to K003155 (2001). 428 ancestors in all. No later device cites it as a predicate yet. 1 of 429 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K171907: Vitality® Spinal Fixation System, Zimmer Biomet Spine, Inc. (2017) Summary page 10. - K152632: XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory, Stryker Corporation (2015) Summary page 10. - K170679: CD HORIZON® Spinal 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 (2017) Summary page 10. ## Indications for use The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft. In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct Java® System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use. In order to achieve additional levels of fixation, the Vitality® Spinal Fixation System rods may be connected to the Instinct Java® System (Ø5.5mm rod) or the Virage® OCT Spinal Fixation System (Ø3.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct Java® System and Virage® OCT Spinal Fixation System package inserts for instructions and indications for use. Vitality®+ Power instruments and adapters are intended for use with the Zimmer Biomet Universal Power System to facilitate the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws using a power surgical technique. Pedicle and iliac screws from the Vitality® Spinal Fixation System may be implanted in the non-cervical spine using powered instrumentation during spinal surgery, including open and minimally invasive procedures. The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft. In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft and/or allogratft. Pediatric pedicle screw fixation is limited to a posterior approach. Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct Java® System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use. In order to achieve additional levels of fixation, the Vitality® Spinal Fixation System rods may be connected to the Instinct Java® System (Ø5.5mm rod) or the Virage® OCT Spinal Fixation System (Ø3.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct Java® System and Virage® OCT Spinal Fixation System package inserts for instructions and indications for use. Source page: https://510kreport.com/device/K172275 Methodology: https://510kreport.com/methodology