# K901005: TSRH Spinal System (Add'l Sizes of Hooks)

- Pathway: 510(k) (Traditional)
- Applicant: Danek Medical, Inc.
- Decided: Dec 10, 1990 after 283 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
580 later devices descend from it; 1 cites it directly.
0 of 581 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
- K950099: Synergy (TM) TI Posterior Spinal System (1997), 579 descendants of its own
- K973836: Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System (1998), 529 descendants of its own
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems (1998), 311 descendants of its own
- K982914: Aesculap Spine System Evolution: Additional Components (1998), 251 descendants of its own
- K980484: Aesculap Spine System Evolution (1998), 251 descendants of its own

Source page: https://510kreport.com/device/K901005
Methodology: https://510kreport.com/methodology