# K102537: Aptus 1.5 Trilock

- Pathway: 510(k) (Special)
- Applicant: Medartis AG
- Decided: Dec 10, 2010 after 98 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: 5 generations back to K962616 (1996). 15 ancestors in all.
19 later devices descend from it; 6 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 2.

## Most influential descendants
- K132769: Acumed Hand Plating System (2014), 7 descendants of its own
- K141383: Acumed Hand Fracture System (2014), 6 descendants of its own
- K140617: Pinit Small Bone Fusion System (2014), 4 descendants of its own
- K234062: APTUS Hand Scaphoid Plates (2024), 3 descendants of its own
- K232144: Sterile Products of the APTUS System (2023), 3 descendants of its own

## Indications for use
The APTUS® 1.5 TniLock is intended for use in hand and forearm fractures, osteotomies and arthrodeses. APTUS® Hand group: * Management of the fractures of the distal, middle and proximal phalanges and metacarpals * Management of all types of transversal fractures, spiral fractures, fractures near joints with or without joint involvement, shaft factures, comminuted fractures, dislocation fractures, avulsion fractures * DIP and PIP arthrodoses APTUS® Radius 2.5 group: * Management via radio volar approach of extra-articular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures * Management via dorsal approach of rare extension fractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.

Source page: https://510kreport.com/device/K102537
Methodology: https://510kreport.com/methodology