# K141850: Flospine Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Flospine
- Decided: Oct 27, 2014 after 110 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: 11 generations back to K040583 (2004). 200 ancestors in all.
No later device cites it as a predicate yet.
1 of 201 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120838: Synthes Matrix System, Synthes Spine (2012) Summary page 5.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 5.

## Indications for use
The FloSpine Canaveral Pedicle System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (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; pseudoarthrosis; and failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Canaveral Pedicle Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Canaveral Pedicle Screw System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to the posterior approach. The Canaveral Pedicle Screw System is indicated to provide the surgeon with a minimally invasive approach for posterior spine surgery.

Source page: https://510kreport.com/device/K141850
Methodology: https://510kreport.com/methodology