# K243943: TriMed® Compression Screws

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Apr 10, 2025 after 111 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). 104 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093676: Omnitech Large, Trimed Compression Screw, TriMed, Inc. (2010) Summary page 5.
- K050681: Omnitech System & Easy Lock Osteosystem with Xtremities Plates, TriMed, Inc. (2005) Summary page 5.
- K161616: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw, Synthes USA Products, LLC (2017) Summary page 6.

## Most influential descendants
- K262344: Large Compression Screws (2026), 0 descendants of its own
- K261241: TriMed Compression Screws (2026), 0 descendants of its own

## Indications for use
The TriMed® Small Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot. The TriMed® Large Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of large bones and large bone fragments in the hand, wrist, elbow, ankle, and foot.

Source page: https://510kreport.com/device/K243943
Methodology: https://510kreport.com/methodology