# K010720: TSRH Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Apr 11, 2001 after 30 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.
249 later devices descend from it; 3 cite it directly.
0 of 250 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
- K103049: TSRH Spinal System (2010), 244 descendants of its own
- K111942: TSRH Spinal Systems (2011), 242 descendants of its own
- K123138: Pass LP Spinal System (2013), 132 descendants of its own
- K121630: Range Spinal System (2012), 127 descendants of its own
- K142798: PASS LP Spinal System (2015), 84 descendants of its own

Source page: https://510kreport.com/device/K010720
Methodology: https://510kreport.com/methodology