# K133564: Modification to Nautilus Spinal System

- Pathway: 510(k) (Special)
- Applicant: Life Spine, LLC
- Decided: Feb 19, 2014 after 91 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: 15 generations back to K040583 (2004). 214 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 228 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132760: Nautilus Spinal System, Life Spine, Inc. (2013) Summary page 1.
- K132471: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 1.

## Most influential descendants
- K191575: ARx Spinal System (2019), 10 descendants of its own
- K200070: ARx Spinal System (2020), 9 descendants of its own
- K203163: ARx Illiac Spinal Screw System (2020), 5 descendants of its own
- K140457: Nautilus Spinal System (2014), 3 descendants of its own
- K183430: Modular Spinal Fixation System (2019), 2 descendants of its own

## Indications for use
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing. The NAUTILUS Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion. When used as a posterior spine thoracic/lumbar system, the NAUTILUS Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, Mnd/or lordlosis), (4) spinal tumor, (5) failed previous fusion (6) pseudartbrosis. (7) spinal stenosis, (8) spondylolisthesis.

Source page: https://510kreport.com/device/K133564
Methodology: https://510kreport.com/methodology