# K011029: Modification to TSRH Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jun 5, 2001 after 61 days
- Product code: MNI (Orthosis, Spinal Pedicle 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.
626 later devices descend from it; 1 cites it directly.
1 of 627 devices in its family (counting itself) has 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
- 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
- K112555: CD Horizon (R) Spinal System (2011), 597 descendants of its own
- K113174: CD Horizon Spinal System (2011), 596 descendants of its own

Source page: https://510kreport.com/device/K011029
Methodology: https://510kreport.com/methodology