# K170821: ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Choicespine, LP
- Decided: Jun 8, 2017 after 80 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: 13 generations back to K853033 (1985). 110 ancestors in all.
No later device cites it as a predicate yet.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102870: Exactech Proliant Polyaxial Pedicle Screw System, Exactech, Inc. (2011) Summary page 4.
- K110551: Expedium Spine System, Johnson & Johnson (2011) Summary page 4.

## Indications for use
The Proliant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The Proliant system is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: (DDD) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis including severe spondylolisthesis (Grades 3 & 4) of L5-S1 vertebra; degenerative spondylolisthesis with abjective evidence of neurologic impairment; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K170821
Methodology: https://510kreport.com/methodology