# K132884: Pathfinder NXT Minimally Invasive Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Nov 25, 2013 after 73 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: 8 generations back to K950697 (1995). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100845: Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 Series, Zimmer Spine, Inc. (2010) Summary page 1.
- K082032: Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310), Abbott Spine, Inc. (2008) Summary page 2.
- K984578: Synergy D2 Spinal Implants, Interpore Cross Intl. (1999) Summary page 2.
- K946348: Titanium TSRH (R) Spinal System (Screws), Sofamor Danek USA,Inc. (1995) Summary page 2.
- (no number) PathFinder NXT® Minimally Invasive Pedicle Screw System: named in the summary without a submission number

## Indications for use
When intended for pedicle screw fixation from TI-Si, the indications include 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion. As a pedicle screw system placed between L3 and Si, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autograft or allograft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

Source page: https://510kreport.com/device/K132884
Methodology: https://510kreport.com/methodology