# K032560: Arrowhead Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Mar 9, 2004 after 202 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
No predicates in its family tree.
787 later devices descend from it; 2 cite it directly.
1 of 788 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CD HORIZON Spinal System: named in the summary without a submission number
- (no number) EQUATION Fixation System: named in the summary without a submission number
- (no number) TSRH Spinal System: named in the summary without a submission number

## Most influential descendants
- K052054: TSRH Spinal System (2005), 786 descendants of its own
- K091974: Modification to CD Horizon Spinal System (2009), 656 descendants of its own
- K072317: Modification to:TSRH Spinal System (2007), 625 descendants of its own
- K081080: TSRH Spinal System (2008), 614 descendants of its own
- K091797: TSRH Spinal System (2010), 606 descendants of its own

## Indications for use
The ARROWHEAD T M Spinal System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (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 in skeletally mature patients.

Source page: https://510kreport.com/device/K032560
Methodology: https://510kreport.com/methodology