# K163383: GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System - Pathway: 510(k) (Traditional) - Applicant: Greens Surgicals Pvt., Ltd. - Decided: Apr 19, 2017 after 139 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). 117 ancestors in all. 3 later devices descend from it; 1 cites it directly. 0 of 121 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 6. - K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 6. - K040777: LCP Radial Head Plating System, Synthes (Usa) (2004) Summary page 6. - K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 6. - K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 6. - K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 6. - K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 7. - K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001) Summary page 7. - K051986: Synthes 4.5 MM LCP Straight Reconstruction Plates, Synthes (Usa) (2005) Summary page 7. - K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 7. - K082625: Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates, Synthes (Usa) (2008) Summary page 7. - K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 7. - K111540: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2011) Summary page 7. - K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates, Synthes (Usa) (2010) Summary page 7. - K032269: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 7. - K082624: Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia Plates, Synthes (Usa) (2008). Our reading of the summary gave K082628, FDA’s number for CMR42 Cardiac Mri Imaging System, 2.1.23 (Circle Cardiovascular Imaging, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes (USA) 3.5mm LCP Posteromedial Proximal Tibia Plates”. - K073460: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 7. - K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 8. - K030858: Synthes (Usa) LCP Proximal Femur Plate and Screws, Synthes (Usa) (2003) Summary page 8. - K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 8. - K923613: Synthes Limited Contact-Dynamic Hip Screw Implant, Synthes (Usa) (1993) Summary page 8. - K953607: Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS), Synthes (Usa) (1996) Summary page 8. - K840954: Dynamic Condylar Screw or D.C.S., Synthes (Usa) (1984) Summary page 8. - K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 8. - K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 9. - K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 9. - K061621: Synthes (Usa) 6.5 MM Cancellous Screws, Synthes (Usa) (2006) Summary page 9. ## 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 GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/Dynamic Condylar Plate Plating System are provided non-sterile. GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges). GREENS Brand of DHS/Dynamic Condylar Plate Plating System is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, pertrochanteric, intertrochanteric fractures. The system is indicated for use in adult patients only. All implants are for single use only. Source page: https://510kreport.com/device/K163383 Methodology: https://510kreport.com/methodology