# K141695: Acrosspine Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Arthro-Dif
- Decided: Dec 30, 2014 after 189 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: 5 generations back to K944736 (1995). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073126: Expedium Spine System, Depuy Spine, Inc. (2007) Summary page 4.
- K090657: Modification to: S4 Spinal System, Aesculap Implant Systems (2009) Summary page 4.
- K082592: LDR Spine Easyspine System, Ldr Spine USA (2008) Summary page 5.
- K091717: Any Plus Spinal Fixation System, GS Medical Co., Ltd. (2010) Summary page 5.

## Indications for use
The Acrosspine Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion 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;

Source page: https://510kreport.com/device/K141695
Methodology: https://510kreport.com/methodology