# K192696: TriMed ASET Foot Plating System

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Jan 5, 2020 after 101 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K954385 (1996). 65 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072740: Mondeal Extremity Bone Fixation System, Mondeal Medical Systems GmbH (2007) Summary page 4.
- K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System, Wrightmedicaltechnologyinc (2015) Summary page 4.

## Most influential descendants
- K233863: TriMed ASET Foot Plating System (1ST MTP  9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T- (2024), 0 descendants of its own

## Indications for use
The TriMed ASET™ Foot Plating System is intended for use in stabilization of fractures, revision procedures, joint fusion, reconstruction, deformity corrections, osteotomies, and non-unions of small bones of the feet. Specific examples include: First metatarsal osteotomies for hallux valgus and hallux varus correction including: • Opening/closing base wedge osteotomies, • Distal and proximal chevron osteotomies, Arthrodesis of the first metatarsal cuneiform joint (Lapidus Fusion); Arthrodesis of the first metatarsophalangeal joint (MTP) including: • Primary MTP fusion due to hallux rigidus and/or hallux valgus, • Revision MTP fusion, • Revision of failed first MTP arthroplasty implant, Metatarsal and Phalanges: • Metatarsal and phalanges fractures and osteotomies; Mid / Hindfoot Fusions: • Tarsometatarsal (TMT) fusions/stabilization, • Intercuneiform fusions.

Source page: https://510kreport.com/device/K192696
Methodology: https://510kreport.com/methodology