# K100845: Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 Series

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Sep 21, 2010 after 180 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K950697 (1995). 40 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082032: Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310), Abbott Spine, Inc. (2008) Summary page 1.
- K030625: Spinal Concepts Inc. Pathfinder, Spinal Concepts, Inc. (2003) Summary page 1.
- K090648: Viper 2 System, Depuy Spine, Inc. (2009) Summary page 1.

## Most influential descendants
- K121130: Polaris Spinal System-Ballista Spinal Rods (2012), 1 descendant of its own
- K132884: Pathfinder NXT Minimally Invasive Pedicle Screw System (2013), 0 descendants of its own
- K123451: Polaris Spinal System - Ballista II Rods (2012), 0 descendants of its own
- K121671: Pathfinder NXT Minimally Invasive Pedicle Screw System (2012), 0 descendants of its own

## Recalls of this device
- Jun 5, 2012 · Class II · Z-1981-2012: Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery.
- Jun 5, 2012 · Class II · Z-1980-2012: Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery.
- Jun 5, 2012 · Class II · Z-1933-2012: Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The complaint investigation showed the hex mating featu
- May 20, 2011 · Not classified · Z-2723-2011: Zimmer Spine, Inc. is initiating a voluntary recall regarding an increased risk of rounding or partial rounding of the hex tip on the 3566-1 (long) and 3566-2 (short) Closure Top Driver used for inser
- May 20, 2011 · Not classified · Z-2722-2011: Zimmer Spine, Inc. is initiating a voluntary recall regarding an increased risk of rounding or partial rounding of the hex tip on the 3566-1 (long) and 3566-2 (short) Closure Top Driver used for inser

## Indications for use
When intended for pedicle screw fixation from T1-S1, 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 S1, 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 solid fusion is established.

Source page: https://510kreport.com/device/K100845
Methodology: https://510kreport.com/methodology