# K142576: Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Eisertech, LLC
- Decided: Feb 26, 2015 after 167 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K984578 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984578: Synergy D2 Spinal Implants, Interpore Cross Intl. (1999) Summary page 5.

## Most influential descendants
- K240963: Spinal System (2024), 0 descendants of its own

## Recalls of this device
- May 21, 2015 · Class II · Z-2070-2015: Shipped to a single consignee prior to completion of final inspection.

## Indications for use
When used as a pedicle screw fixation system, the Eisertech Spinal System 1s intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (as defined by back pan of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Degenerative spondylolisthesis with objective evidence of neurologic impairment 3. Fracture 4. Dislocation 5. Scoliosis 6. Kyphosis 7. Spinal tumor and/or 8. Failed previous fusion (pseudoarthrosis) The Eisertech Spinal System 1s also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attamnment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Eisertech Spinal System 1s also intended for the following indications: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Spinal stenosis 3. Spondylolisthesis 4. Spinal deformities 5. Fracture 6. Pseudoarthrosis 7. Tumor resection and/or 8. Failed previous fusion

Source page: https://510kreport.com/device/K142576
Methodology: https://510kreport.com/methodology