# K183550: Vitality® Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Biomet Spine, Inc.
- Decided: Apr 8, 2019 after 109 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K203507: Vitality® Spinal Fixation System (2021), 8 descendants of its own
- K230116: Vital™ Spinal Fixation System (2023), 5 descendants of its own
- K240539: Vital™ Spinal Fixation System (2024), 4 descendants of its own
- 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

## Recalls of this device
- May 5, 2020 · Class II · Z-2212-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2231-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2225-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2229-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2219-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2221-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2218-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2230-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2226-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2211-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2224-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2217-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2216-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2214-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2232-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2223-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2222-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2233-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2220-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2227-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2234-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2210-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2228-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

Source page: https://510kreport.com/device/K183550
Methodology: https://510kreport.com/methodology