# K152781: Adena-Zina System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Sanyou Medical Co, Ltd.
- Decided: Feb 12, 2016 after 140 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 K040583 (2004). 143 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123809: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 4.
- K013962: Equation Fixation System, Medtronic Sofamor Danek, Inc. (2002) Summary page 5.
- K122332: Towerlox Pedicle Screw System, Captiva Spine (2012) Summary page 5.

## Most influential descendants
- K212066: Adena-Zina System (2021), 3 descendants of its own
- K230961: Zeus Spinal System (2023), 2 descendants of its own
- K240392: JAZZ Spinal System (2024), 1 descendant of its own
- K252437: JAZZ Spinal System (2025), 0 descendants of its own
- K231931: Adena-Zina Spinal System (2023), 0 descendants of its own

## Indications for use
The Adena-Zina System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. In addition, when used as a pedicle screw fixation system, the Adena-Zina System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K152781
Methodology: https://510kreport.com/methodology