# K161894: SurgTech Trauma System - Pathway: 510(k) (Traditional) - Applicant: Surgtech, Inc. - Decided: Feb 21, 2017 after 225 days - Product code: HWC (Screw, Fixation, Bone) - Device class: 2 - Regulation: 21 CFR 888.3040 - 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. 3 later devices descend from it; 1 cites it directly. 0 of 180 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K092493: GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate System, Gpc Medical, Ltd. (2010) Summary page 5. - K100111: NCB Periprosthetic Femur Polyaxial Locking Plate System, Zimmer, Inc. (2010) Summary page 6. - K060156: Straight Plate with Angular Stability & Screw System, I.T.S. Implantat-Technologie-Systeme GmbH (2006) Summary page 6. - K033756: Volar Radius Plate with Angular Stability, I.T.S. Implantat-Technologie-Systeme GmbH (2004) Summary page 6. - K052368: Olecranonplate with Angular Stability, I.T.S. Implantat-Technologie-Systeme GmbH (2005) Summary page 6. - K120070: Synthes Variable Angle LCP Elbow System, Synthes USA (2012) Summary page 6. - K080184: Distal Humeral Plates with Angular Stability, I.T.S. Implantat-Technologie-Systeme GmbH (2008) Summary page 6. - K050852: Claviculaplate with Angular Stablity Bone Plate System, I.T.S. Implantat-Technologie-Systeme GmbH (2005) Summary page 6. - K031677: Synthes (Usa) Calvicle Hook Plate, Synthes (Usa) (2003) Summary page 6. - K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 6. - K063166: I.T.S. Pelvic Reconstruction System, I.T.S. Implantat-Technologie-Systeme GmbH (2006) Summary page 6. - K063672: Fibula Plate Prolock with Angular Stability, I.T.S. Implantat-Technologie-Systeme GmbH (2007) Summary page 6. - K082300: Anatomic Locking Plating System, DePuy Orthopaedics, Inc. (2009) Summary page 6. - K141383: Acumed Hand Fracture System, Acumed, LLC (2014) Summary page 6. - K991407: Synthes Locking Calcaneal Plates, Synthes (Usa) (1999) Summary page 6. - K051642: FR.O.H. Calcaneus Repair System, I.T.S. Implantat-Technologie-Systeme GmbH (2005) Summary page 6. - K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 6. - K091479: Aptus Foot System, Medartis AG (2009) Summary page 6. - K915818: Synthes (R) Titanium Small Reconstruction Plate, Synthes (Usa) (1992) Summary page 6. - K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 6. - K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 6. - K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 6. - K063298: Osteomed Headless Cannulated Screw System, Osteomed LP (2007) Summary page 6. - K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins, Treu-Instrumente GmbH (2009) Summary page 6. - K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 6. - K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005) Summary page 6. - K080943: Synthes 4.5 MM and 6.5 MM Headless Compression Screws, Synthes (Usa) (2008) Summary page 6. - K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00, Vilex, Inc. (2002) Summary page 6. - K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 6. - K092754: Sbi Foot and Ankle Cannulated Screw System, Model 100-0061, Small Bone Innovations, Inc. (2010) Summary page 6. ## Most influential descendants - K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own - K261830: FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) (2026), 0 descendants of its own - K260277: Mikron Trauma Bone Plate& Screw System (2026), 0 descendants of its own ## Indications for use The SurgTech Trauma System plates and screws are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions appropriate for the size and design of the device. The large plate set components are indicated for the use in various long bones including the femur and tibia. The small plate set is indicated for use in various bones including the clavicle, scapula, humerus, radius, radius, ulna, pelvis, tibia and fibula. The mini plate set is indicated for use in various small bones including the metacarpals, metatarsals, phalanges, calcaneus and those of the ankle. In addition, the SurgTech Trauma System cancellous, cannulated lag, headless compression and non-locking cortical screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Source page: https://510kreport.com/device/K161894 Methodology: https://510kreport.com/methodology