# K130614: Bone Fragment and Fixation Plates, Screws and Washers

- Pathway: 510(k) (Traditional)
- Applicant: Laura Cattabriga
- Decided: Jan 17, 2014 after 316 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: 7 generations back to K000684 (2000). 31 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110086: Ifs Profile Plates, Screws, and Washers, Internal Fixation Systems, Inc. (2011)
- K052483: Synthes (Usa) Spherical Washers, Synthes (Usa) (2005) Summary page 2.

## Most influential descendants
- K250055: BPS - Bone Fragment Fixation Plates, Screws and Washers (2025), 1 descendant of its own
- K252758: Cannulated Screw and Kirschner (K wire) System (2025), 0 descendants of its own

## Indications for use
The Core Orthopaedics 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/K130614
Methodology: https://510kreport.com/methodology