# K051567: Aptus Titanium Osteosynthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis, Inc.
- Decided: Aug 23, 2005 after 70 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962616 (1996). 14 ancestors in all.
157 later devices descend from it; 22 cite it directly.
0 of 172 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961497: Profyle Titanium Hand and Small Fragment System, Howmedica, Inc. (1996) Summary page 2.
- K040022: Stryker Leibinger Universal Distal Radius System, Stryker Leibinger (2004) Summary page 2.
- K002775: Distal Volar Radius Fracture Repair System, Hand Innovations, Inc. (2000) Summary page 2.
- K023007: Distal Radius Fracture Repair System, Hand Innovations, Inc. (2002) Summary page 2.
- K030198: Hand Innovations, Inc. Distal Radius Fracture Repair System, Hand Innovations, Inc. (2003) Summary page 2.
- K041081: Fragment Plate System, Screws, Pins and K-Wires, Hand Innovations, Inc. (2004) Summary page 2.

## Most influential descendants
- K062498: Profyle System (2006), 81 descendants of its own
- K103332: Aptus Ulna Plates (2011), 71 descendants of its own
- K073527: Variax Elbow System (2008), 61 descendants of its own
- K142906: APTUS Wrist 2.5 System (2015), 59 descendants of its own
- K101056: Variax Elbow System (2010), 58 descendants of its own

## Recalls of this device
- Jan 9, 2026 · Class II · Z-1549-2026: Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

## Indications for use
The APTUS® Titanium Fixation System 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/K051567
Methodology: https://510kreport.com/methodology