# K011067: Modification to TSRH Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: May 4, 2001 after 25 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 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
- K072429: Modification to TSRH Spinal System (2007), 10 descendants of its own
- K081978: Reliance Spinal Screw System (2009), 8 descendants of its own
- K101112: Reliance Spinal Screw System (2010), 7 descendants of its own
- K123521: Reliance Spinal Screw System (2013), 5 descendants of its own
- K110896: Reliance Spinal Screw System (2012), 5 descendants of its own

Source page: https://510kreport.com/device/K011067
Methodology: https://510kreport.com/methodology