# K946348: Titanium TSRH (R) Spinal System (Screws)

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Aug 7, 1995 after 220 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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.
12 later devices descend from it; 2 cite it directly.
0 of 13 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
- K131980: Sequoia Pedicle Screw System Including Speedlink II Transverse Connector System (2013), 10 descendants of its own
- K203507: Vitality® Spinal Fixation System (2021), 8 descendants of its own
- K230116: Vital™ Spinal Fixation System (2023), 5 descendants of its own
- K240539: Vital™ Spinal Fixation System (2024), 4 descendants of its own
- K253721: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2025), 2 descendants of its own

Source page: https://510kreport.com/device/K946348
Methodology: https://510kreport.com/methodology