# K093676: Omnitech Large, Trimed Compression Screw

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Mar 17, 2010 after 110 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: 3 generations back to K903810 (1990). 8 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999)
- K060736: Smith & Nephew 6.5MM and 8.0MM Cannulated Screws, Smith & Nephew, Inc. (2006) Summary page 2.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 2.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 2.

## Most influential descendants
- K112794: Eos Small Bone Fixation System (2012), 9 descendants of its own
- K153395: OS2-C Compression Staple (2016), 7 descendants of its own
- K163440: Stealth Staple System (2017), 3 descendants of its own
- K243943: TriMed® Compression Screws (2025), 2 descendants of its own
- K212594: OSSIOfiber® Staple (2022), 2 descendants of its own

## Indications for use
The TrilMed Omnitech Large System is indicated for fracture fixation of large bone and large bone fragments, as well as fractures of the calcaneus, talus, and pelvis.

Source page: https://510kreport.com/device/K093676
Methodology: https://510kreport.com/methodology