# K191793: Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Nebula Surgical Private Limited
- Decided: Dec 9, 2019 after 159 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). 111 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953644: Volar Distal Radius Plate, Synthes (Usa) (1996) Summary page 4.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 4.
- K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 4.
- K051986: Synthes 4.5 MM LCP Straight Reconstruction Plates, Synthes (Usa) (2005) Summary page 4.
- K111540: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2011) Summary page 4.
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 5.
- K073460: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 5.
- K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates, Synthes (Usa) (2010) Summary page 5.
- K032269: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 5.
- K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 5.
- K961413: Synthes Anatomical Locking Plate System, Synthes (Usa) (1996) Summary page 5.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 5.
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001) Summary page 5.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 5.
- K923613: Synthes Limited Contact-Dynamic Hip Screw Implant, Synthes (Usa) (1993) Summary page 5.
- K953607: Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS), Synthes (Usa) (1996) Summary page 5.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 5.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 5.
- K061621: Synthes (Usa) 6.5 MM Cancellous Screws, Synthes (Usa) (2006) Summary page 5.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 5.

## 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
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are provided non-sterile. NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS 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). The system is indicated for use in adult patients only. All implants are for single use only.

Source page: https://510kreport.com/device/K191793
Methodology: https://510kreport.com/methodology