# K240539: Vital™ Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Zimvie Spine (Zimmer Biomet Spine, Inc.)
- Decided: Mar 15, 2024 after 18 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: 5 generations back to K021564 (2002). 9 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230116: Vital™ Spinal Fixation System, Zimvie Spine (Zimmer Biomet Spine, Inc.) (2023) Summary page 5.

## Most influential descendants
- K253721: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2025), 2 descendants of its own
- K260786: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 1 descendant of its own
- K262828: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 0 descendants of its own
- K253093: Vital™ Spinal Fixation System (2025), 0 descendants of its own

## Indications for use
The Vital Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1S2/ilium), posterior hook fixation (T1L5), or anterolateral fixation (T8LYS). 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 studies), 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 Vital Spinal Fixation System is intended to be used with autograft and/or allograft. In addition, the Vital Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5S1 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 Vital System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vital System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The use of the Vital Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® Java™ Spinal Fixation System hooks, APEX Spinal System™ hooks, or fixation of the Universal Clamp® Spinal Fixation System to the rods of the Vital Spinal Fixation System. The Vital Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System. To achieve additional levels of fixation in skeletally mature patients, the Vital Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.

Source page: https://510kreport.com/device/K240539
Methodology: https://510kreport.com/methodology