# K071174: Pathfinder System Polyaxial Pedicle Screws

- Pathway: 510(k) (Special)
- Applicant: Abbott Spine, Inc.
- Decided: Jul 25, 2007 after 89 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K021564 (2002). 3 ancestors in all.
94 later devices descend from it; 1 cites it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030625: Spinal Concepts Inc. Pathfinder, Spinal Concepts, Inc. (2003) Summary page 1.

## Most influential descendants
- K113044: Synthes Mirs (2011), 93 descendants of its own
- K120571: Synthes Uss Connector (2012), 74 descendants of its own
- K133746: Polaris Spinal System (2014), 67 descendants of its own
- K143248: Reform Pedicle Screw System (2014), 30 descendants of its own
- K150856: Reform Pedicle Screw System (2015), 26 descendants of its own

## Recalls of this device
- Apr 13, 2010 · Not classified · Z-0075-2011: The tip of the PathFinder End Screw Extender Sleeve has fractured during use. In some cases, this instrument fracture led to surgical delay or additional surgical steps necessary to remove the fragmen
- Jan 12, 2009 · Not classified · Z-2335-2010: The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site.
- Apr 17, 2008 · Not classified · Z-1784-2008: Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely. The firm has received internal non-conformances and complaints where the tips of the Awl were worn and damaged. Of the tip bre
- Mar 24, 2008 · Not classified · Z-1593-2008: Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.

## Indications for use
PathFinder - Mini-Open Posterior Approach When intended for pedicle screw fixation from LI-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 autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established. After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking info consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

Source page: https://510kreport.com/device/K071174
Methodology: https://510kreport.com/methodology