# K230507: Zimed Distal Medial Tibial Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Zimed Medikal
- Decided: Jan 4, 2024 after 314 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
Longest line of descent: 12 generations back to K962616 (1996). 101 ancestors in all.
No later device cites it as a predicate yet.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 4.
- K222282: HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, Hospital Equipment Manufacturing Company (2022) Summary page 4.

## Indications for use
The Zimed Distal Medial Tibial Plate and Screw System is indicated for fixation of complex extra-articular and intra-articular distal medial tibial fractures and osteotomies.

Source page: https://510kreport.com/device/K230507
Methodology: https://510kreport.com/methodology