# K973145: Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Nov 19, 1997 after 89 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K021684: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (2002), 7 descendants of its own
- K062819: Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery (2006), 3 descendants of its own
- K073006: Osteotrans -MX Bioabsorbable Bone Fixation System (2008), 2 descendants of its own
- K023810: Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (2002), 1 descendant of its own
- K022033: Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation System (2002), 1 descendant of its own

## Indications for use
The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System is intended for use in any oral-maxilio-cranio-facial surgical procedure, either orthognathic or trauma, wherein rigid or semi-rigid internal fixation is utilized as a means of holding bone fragments together.

Source page: https://510kreport.com/device/K973145
Methodology: https://510kreport.com/methodology