# K974017: Timesh System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Jan 16, 1998 after 86 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
53 later devices descend from it; 7 cite it directly.
0 of 54 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
- K994158: Macrosorbos Protective Sheet (2000), 35 descendants of its own
- K031961: Inion Otps Biodegradable Mesh Plating System (2004), 21 descendants of its own
- K123672: Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) (2013), 17 descendants of its own
- K160304: OsteoBullet Compression Screw (2016), 8 descendants of its own
- K022139: Hip Tool Implant (2002), 7 descendants of its own

## Recalls of this device
- Mar 8, 2006 · Not classified · Z-0849-06: Medtronic Neurosurgery has initiated this action because it was determined that two lots of the Modular Screwdriver Blade components may exhiibt burrs along the tips of the Screwdriver, which may prev

## 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 fixation 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/K974017
Methodology: https://510kreport.com/methodology