# K250055: BPS - Bone Fragment Fixation Plates, Screws and Washers

- Pathway: 510(k) (Special)
- Applicant: Orthonovis, Inc.
- Decided: Feb 6, 2025 after 27 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: 8 generations back to K000684 (2000). 61 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130614: Bone Fragment and Fixation Plates, Screws and Washers, Laura Cattabriga (2014) Summary page 5.
- K110086: Ifs Profile Plates, Screws, and Washers, Internal Fixation Systems, Inc. (2011) Summary page 5.
- K113733: Small and Large Fragments Osteosynthesis System Neofix, Neoortho Produtos Ortopedicos S/A (2012) Summary page 5.

## Most influential descendants
- K252758: Cannulated Screw and Kirschner (K wire) System (2025), 0 descendants of its own

## Indications for use
The OrthoNovis bones plates and screws system are intended to be used for internal fixation of bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bone (such as humerus, ulna, radius, femur, tibia, and fibula, and small bones (such as metacarpals, metatarsals, phalanges). The washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments.

Source page: https://510kreport.com/device/K250055
Methodology: https://510kreport.com/methodology