# 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-

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Apr 17, 2024 after 133 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: 14 generations back to K954385 (1996). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192696: TriMed ASET Foot Plating System, TriMed, Inc. (2020) Summary page 6.
- K222194: Baby Gorilla®/Gorilla® Plating System, Paragon 28, Inc. (2022) Summary page 6.
- K072740: Mondeal Extremity Bone Fixation System, Mondeal Medical Systems GmbH (2007) Summary page 6.

## Indications for use
The TriMed ASET™ Foot Plating System is indicated for use in stabilization of fractures, revision procedures, joint fusions, reconstructions, 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, Ludloff Osteotomy, 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 Fractures: Cuneiform Fracture, Cuboid Fracture, Navicular Fracture Mid / Hindfoot Fusions: Tarsometatarsal (TMT) Fusions/Stabilization, Intercuneiform Fusions, Navicular Cuneiform (NC) Fusion, Talonavicular (TN) Fusion, Calcaneocuboid (CC) Fusion, Medial Column Fusion, Medial Column Fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot), Lateral Column Fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot) Mid / Hindfoot Osteotomies (Deformity Corrections): Lateral Column Lengthening (Evans Osteotomy), Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy), Medial Displacement Calcaneal Osteotomy

Source page: https://510kreport.com/device/K233863
Methodology: https://510kreport.com/methodology