# K062348: Timesh Self Drilling Screw

- Pathway: 510(k) (Special)
- Applicant: Medtronic Neurosurgery
- Decided: Sep 8, 2006 after 28 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: 1 generation back to K923419 (1993). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974017: Timesh System, Sofamor Danek USA,Inc. (1998) Summary page 1.
- K923419: Tismesh System, Ti-Mesh, Inc. (1993) Summary page 1.

## Most influential descendants
- K100779: Sustain Space Maintenance System (2010), 2 descendants of its own
- K110259: Architex Space Maintenance System (2011), 1 descendant of its own
- K120271: Artisan Space Maintenance System (2012), 0 descendants of its own

## Indications for use
The TiMesh System is intended for use in any oral-maxillo-cranio-facial surgical reconstructive procedure, either orthognathic or trauma, wherein rigid or semi-rigid internal fixatlon Is utilized as a means of holding bone fragments together. Alternatively, the TiMesh System is also indicated for use in reinforcing weak bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, and cement restriction. This product is not intended for spinal use.

Source page: https://510kreport.com/device/K062348
Methodology: https://510kreport.com/methodology