# K000089: Synthes 4.0 and 5.0 MM Locking Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Feb 3, 2000 after 22 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 9 cite it directly.
0 of 42 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
- K103002: Synthes Multiloc Proximal Humeral Nailing System (2011), 17 descendants of its own
- K120807: Synthes Multiloc Humeral Nailing System (2012), 15 descendants of its own
- K113733: Small and Large Fragments Osteosynthesis System Neofix (2012), 11 descendants of its own
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX (2014), 8 descendants of its own

Source page: https://510kreport.com/device/K000089
Methodology: https://510kreport.com/methodology