# K011458: Synthes Straight Wrist Fusion Plate, 170MM

- Pathway: 510(k) (Abbreviated)
- Applicant: Synthes (Usa)
- Decided: Aug 2, 2001 after 83 days
- Product code: KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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; 3 cite 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
- K112169: Aptus Wrist Arthrodesis Plates (2012), 8 descendants of its own
- K192297: APTUS Wrist Arthrodesis Plates (2019), 7 descendants of its own
- K223853: Medartis APTUS® Ulna Plates (2023), 5 descendants of its own
- K234062: APTUS Hand Scaphoid Plates (2024), 3 descendants of its own
- K232144: Sterile Products of the APTUS System (2023), 3 descendants of its own

Source page: https://510kreport.com/device/K011458
Methodology: https://510kreport.com/methodology