# K243469: Signex

- Pathway: 510(k) (Traditional)
- Applicant: Osteonic Co., Ltd.
- Decided: May 29, 2025 after 202 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 K962616 (1996). 176 ancestors in all.
No later device cites it as a predicate yet.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230546: Signex, Osteonic Co., Ltd. (2024) Summary page 5.
- K102998: Congruent Bone Plate  System, Acumed, LLC (2011) Summary page 5.
- K102537: Aptus 1.5 Trilock, Medartis AG (2010) Summary page 5.
- K090053: Aptus 2.0 Radial Head System, Medartis AG (2009) Summary page 5.
- K110908: Aptus Foot 3.5 System, Medartis AG (2011) Summary page 5.
- K091479: Aptus Foot System, Medartis AG (2009) Summary page 5.
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 5.
- K103332: Aptus Ulna Plates, Medartis AG (2011) Summary page 5.
- K141796: Depuy Synthes Tomofix Osteotomy System, Synthes (USA) Products, LLC (2014) Summary page 5.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 5.
- K083694: Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates, Synthes (Usa) (2009) Summary page 5.
- K050646: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates, Synthes (Usa) (2005) Summary page 5.
- K082072: Synthes (Usa) 3.5MM LCP Hook Plate, Synthes (Usa) (2008) Summary page 5.
- K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 5.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 5.
- K083213: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 5.
- K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP), Synthes (Usa) (2009) Summary page 6.
- K111540: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2011) Summary page 6.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 6.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 6.
- K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 6.
- K120070: Synthes Variable Angle LCP Elbow System, Synthes USA (2012) Summary page 6.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 6.

## Indications for use
The SIGNEX plates and screws are indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Hand System is indicated for fixation of hand (metacarpals, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Wrist System is indicated for fixation of wrist (distal radius, ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Forearm System is indicated for fixation of forearm (radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Elbow System is indicated for fixation of elbow (distal humerus, olecranon, proximal radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Humerus System is indicated for fixation of humerus fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Foot System is indicated for fixation of foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Fibula System is indicated for fixation of fibula fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Tibia System is indicated for fixation of tibia fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Femur System is indicated for fixation of femur fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Clavicle System is indicated for fixation of clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Universal Plates are indicated for fixation of arm (humerus, radius, ulna), leg (femur, tibia, fibula), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

Source page: https://510kreport.com/device/K243469
Methodology: https://510kreport.com/methodology