# K053623: Nfix Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: N-Spine, Inc.
- Decided: Jul 12, 2006 after 196 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Moss Miami Spinal System: named in the summary without a submission number

## Most influential descendants
- K061774: Nfix II Pedicle Screw System (2006), 2 descendants of its own
- K080876: DVX Spine System (2008), 1 descendant of its own
- K090424: DVX Spine System (2009), 0 descendants of its own
- K073143: Modified Vertiflex Spinal Screw System (2008), 0 descendants of its own
- K072685: Ngarde System (2007), 0 descendants of its own

## Indications for use
NFix Indications for Use: The NFix Fusion System is intended for posterior, noncervical, pedicle fixation in order 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 thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the NFix Fusion System is intended for skeletally mature with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

Source page: https://510kreport.com/device/K053623
Methodology: https://510kreport.com/methodology