# K230971: APTUS® 3.5 TriLock Straight Plates

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Jun 2, 2023 after 58 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: 7 generations back to K000684 (2000). 40 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193633: APTUS® Ankle Trauma System 2.8/3.5, Medartis AG (2020) Summary page 4.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 4.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 5.
- K110908: Aptus Foot 3.5 System, Medartis AG (2011) Summary page 4.
- K193639: APTUS® Foot 2.8-3.5 System, Medartis AG (2020) Summary page 4.

## Most influential descendants
- K232251: APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension (2023), 1 descendant of its own
- K260934: TITAN Nail; APTUS K-Wire System (2026), 0 descendants of its own

## Indications for use
The APTUS 3.5 TriLock Straight Plates are intended for the fixation of fractures, osteotomies and non-unions of the scapula, olecranon, radius, ulna, foot, distal tibia and fibula.

Source page: https://510kreport.com/device/K230971
Methodology: https://510kreport.com/methodology