# K143200: MIS Z-Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Z-Medical GmbH & Co. KG
- Decided: Feb 3, 2015 after 89 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: 14 generations back to K853033 (1985). 76 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031655: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2003) Summary page 5.
- K090648: Viper 2 System, Depuy Spine, Inc. (2009) Summary page 5.
- K131802: Expedium, Viper. Viper 2 Spine System, Depuy Spine, A Johnson & Johnson Company (2013) Summary page 5.

## Most influential descendants
- K151727: Everest Spinal System (2015), 11 descendants of its own
- K161369: EVEREST Spinal System (2016), 9 descendants of its own
- K181188: EVEREST Spinal System (2018), 6 descendants of its own
- K181603: EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System (2018), 5 descendants of its own
- K222684: XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (2023), 4 descendants of its own

## Indications for use
The MIS Z-Pedicle Screw System is intended to provide immobilization and stabilization of the spinal segments for posterior, non-cervical pedicle fixation in skeletally mature patients 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 (grades 3 and 4) at L5-S1 trauma (i.e., fracture or dislocation) spinal stenosis curvatures (i.e.,scoliosis, kyphosis, and/or lordosis) tumor pseudoarthrosis failed previous fusion.

Source page: https://510kreport.com/device/K143200
Methodology: https://510kreport.com/methodology