# K131427: LOTUS

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Oct 24, 2013 after 160 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K853033 (1985). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120467: Spinal Elements Posterior Cervical/Thoracic Spinal System, Spinal Elements, Inc. (2012) Summary page 1.

## Indications for use
The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (C1-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; tumors. The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System may be used in conjunction with the Spinal Elements Mercury system for transition at T1-T3. The use of polyaxial pedicle screws is limited to placement in T1-T3 for treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K131427
Methodology: https://510kreport.com/methodology