# K171690: Trident Extremity Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Trident Orthopedics
- Decided: May 8, 2018 after 335 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: 11 generations back to K954385 (1996). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151235: Medline Foot Plates and Screws, Medline Industries, Inc. (2015) Summary page 5.
- K991151: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw, Vilex, Inc. (1999) Summary page 5.
- K991197: Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24, Vilex, Inc. (1999) Summary page 5.
- K151021: OsteoMed Cannulated Screw System, Osteomed Corp. (2015) Summary page 5.

## Indications for use
The Trident Extremity Fixation System consisting of plates and screws are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of bone of the feet, hand, ankle and toes. Specific examples include: - Arthrodesis of the first metatarsalcuneiform joint (Lapidus fusion procedure) - Arthrodesis of the first metatarsalphalangeal joint (MTP fusion procedure) - Primary and revision MTP fusion due to hallux rigidus and/or hallux valgus corrections - Revision of failed first MTP arthroplasty implant 2nd, 3rd and 4th metatarsal weil osteotomy correction indications - Metatarsal osteotomies to correct hallux valgus bunion indications - Fractures of the fifth metatarsal bone in the foot - Carpal bone fusions and fractures Flatfoot Osteotomies: - Lateral column lengthening (Evans osteotomy) - Plantar flexion opening wedge osteotomy of the medial cuneiform (Cotton osteotomy) - Medial displacement calcaneal osteotomy Midfoot/Hindfoot Arthrodesis/Fusions - Lisfranc arthrodesis and/or stabilization - 1st, 2nd, 3rd and 4th Tarsometatarsal (TMT) fusions - Navicular-Cuneiform (NC) joint fusions - Talo-Navicular (TN) joint fusions - Calcaneo-Cuboid (CC) joint fusions - Medial column fusions (NC and 1st TMT) The Trident Extremity Fixation System screws and plates are indicated for use with the Trident Plates and Screws of the same material. The locking and non-locking solid cortical screws, cannulated screws and headless screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.

Source page: https://510kreport.com/device/K171690
Methodology: https://510kreport.com/methodology