# K232144: Sterile Products of the APTUS System

- Pathway: 510(k) (Special)
- Applicant: Medartis AG
- Decided: Aug 18, 2023 after 30 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: 8 generations back to K962616 (1996). 33 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 37 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 5.
- K090983: Aptus 2.0/2.3 Four Corner Fusion Plate, Medartis AG (2009) Summary page 5.
- K092038: Aptus K-Wire System, Medartis AG (2009) Summary page 5.
- K102537: Aptus 1.5 Trilock, Medartis AG (2010) Summary page 5.
- K103332: Aptus Ulna Plates, Medartis AG (2011) Summary page 5.
- K142906: APTUS Wrist 2.5 System, Medartis AG (2015) Summary page 6.
- K172170: APTUS (R) Wrist 2.5 System, Medartis AG (2017) Summary page 6.
- K192297: APTUS Wrist Arthrodesis Plates, Medartis AG (2019) Summary page 6.
- K193554: APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System, Medartis AG (2020) Summary page 6.

## Most influential descendants
- K243610: APTUS Hand System; APTUS Elbow Dorsal Olecranon (2025), 2 descendants of its own
- K260761: APTUS Clavicle System 2.8 (2026), 0 descendants of its own
- K253916: APTUS Shoulder Proximal Humerus System, PentaLock 3.5 (2026), 0 descendants of its own

## Indications for use
APTUS® Titanium Fixation System The APTUS® Titanium Fixation System is indicated 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 fractures, comminuted fractures, dislocation fractures, avulsion fractures • DIP and PIP arthrodeses 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. APTUS® 2.0/2.3 Four Corner Fusion Plate The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand. APTUS® K-Wire System The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants. APTUS® 1.5 TriLock The APTUS® 1.5 TriLock is indicated 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 fractures, comminuted fractures, dislocation fractures, avulsion fractures • DIP and PIP arthrodeses 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. APTUS® Ulna Plates APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna. APTUS® Wrist 2.5 System APTUS® Wrist 2.5 System is indicated for use in hand and forearm fractures, osteotomies and arthrodeses. APTUS® Wrist Arthrodesis Plates APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis. APTUS® Forearm Shaft Plates APTUS® Forearm Shaft Plates are indicated for management of fractures and osteotomies of the radius and ulna shaft.

Source page: https://510kreport.com/device/K232144
Methodology: https://510kreport.com/methodology