# K884263: Rogozinski Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Richards Medical Co., Inc.
- Decided: Dec 29, 1988 after 79 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.
37 later devices descend from it; 2 cite it directly.
0 of 38 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
- K983904: Rogozinski Spinal Rod System (1998), 27 descendants of its own
- K031595: U & I America Spinal Hook System (2003), 14 descendants of its own
- K100757: Tilock Pedicle Screw System (2010), 9 descendants of its own
- K103671: Genesys Spine Tilock System (2011), 8 descendants of its own
- K101682: S 100 Pedicle Screw System (2010), 8 descendants of its own

Source page: https://510kreport.com/device/K884263
Methodology: https://510kreport.com/methodology