# K170045: Swedge™ Pedicle Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Resources, Inc.
- Decided: Jun 26, 2017 after 172 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K230482: Swedge™ Pedicle Screw Fixation System (2023), 1 descendant of its own
- K252461: Swedge™ Pedicle Screw Fixation System Bezier Rod (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K170045
Methodology: https://510kreport.com/methodology