# K242988: Genostis Osteosynthesis System - Pathway: 510(k) (Traditional) - Applicant: Genostis AF - Decided: Jun 27, 2025 after 274 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: 12 generations back to K962616 (1996). 115 ancestors in all. No later device cites it as a predicate yet. 0 of 116 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 7. - K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 7. - K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 7. - K010321: Modular Foot System - 2.7 MM Module, Synthes (Usa) (2001) Summary page 7. - K010766: Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T Plate, Synthes (Usa) (2001) Summary page 7. - K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 7. - K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 8. - K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 8. - K040777: LCP Radial Head Plating System, Synthes (Usa) (2004) Summary page 8. - K041911: Synthes (Usa) LCP Curved Plates, Synthes (Usa) (2004) Summary page 8. - K052390: Synthes LCP Proximal Tibia Plates Line Extension, Synthes (Usa) (2005) Summary page 8. - K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 8. - K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 8. - K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 8. - K073186: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2007) Summary page 8. - K080522: Synthes 3.5 MM LCP Distal Tibia T Plates, Synthes (Usa) (2008) Summary page 8. - K082625: Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates, Synthes (Usa) (2008) Summary page 8. - K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates, Synthes (Usa) (2010) Summary page 8. - K102998: Congruent Bone Plate System, Acumed, LLC (2011) Summary page 8. - K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 8. - K161616: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw, Synthes USA Products, LLC (2017) Summary page 8. - K071715: Acumed Congruent Bone Plate System, Acumed, LLC (2007) ## Indications for use Intended Use: Plate and screw Implants are intended for temporary fixation, correction or stabilization of bones in various anatomical regions. One-Quarter Tubular Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius). The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. Straight Plates 2.4/2.7 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the foot, hand, wrist, and forearm (including radius) and arthrodesis of small bones of the foot and hand. Reconstruction Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius) Radius Distal Styloid Plate 2.4/2.7 is indicated for the fixation for fractures of the radial styloid that have metaphyseal comminution or as an adjunct to either volar of dorsal plate fixation when additional support of the radial styloid is required. The Radius Proximal head plates 2.4/2.7 are indicated for extra-articular and intra-articular fractures of the proximal radius and multifragmented radial neck fractures. The Radius Distal Volar Plates 2.4/2.7 are indicated for the fixation for fractures, fusions, or osteotomies of the distal radius. One-Third Tubular Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), and fibula. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. Reconstruction Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), wrist, and forearm (including radius), fibula, and calcaneus Straight Plates 3.5 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the elbow (distal humerus and ulna), wrist, forearm (including radius), and fibula. Tibia T-Plates 3.5 are indicated for buttressing of partial articular fractures and bone fragments of the distal tibia. The Clavicle Superior Plates 3.5 are indicated for: — Fractures of the clavicle shaft — Fractures of the lateral clavicle — Malunions of the clavicle — Non-unions of the clavicle The Clavicle Hook Plate 3.5 is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. The Humerus Proximal Plates 3.5 are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus. The Tibia Proximal Lateral Plates 3.5 are indicated for: — Split-type fractures of the lateral tibial plateau — Lateral split fractures with associated depressions — Pure central depression fractures — Split or depression fractures of the medial plateau The Tibia Distal Medial Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia. The Tibia Distal Anterolateral Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia. The Humerus Distal Dorsolateral Plates 2.7/3.5 are indicated for — Intraarticular fractures of the distal humerus — Supracondylar fractures of the distal humerus — Non-unions of the distal humerus The Humerus Distal Medial Plates 2.7/3.5 are indicated for — Intraarticular fractures of the distal humerus — Supracondylar fractures of the distal humerus — Non-unions of the distal humerus The Ulna Proximal Olecranon Plates 3.5 are indicated for — Complex extra- and intra-articular olecranon fractures — Non-unions of the proximal ulna — Osteotomies — Simple olecranon fractures Broad Curved Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia. Broad Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia. Narrow Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, and distal tibia. T Plate 4.5/5.0 is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. T-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. LL-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. Femur Distal Plates 4.5/5.0 are indicated for distal shaft fractures, supracondylar fractures, intraarticular fractures, and periprosthetic fractures of the distal femur Tibia Proximal Lateral Plates 4.5/5.0 are indicated for proximal shaft fractures, metaphyseal fractures, intra-articular fractures and periprosthetic fractures of the proximal tibia. Source page: https://510kreport.com/device/K242988 Methodology: https://510kreport.com/methodology