# K143023: Nitinol Compression Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Enterprises, Inc.
- Decided: Jan 16, 2015 after 87 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: 4 generations back to K983495 (1998). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 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 4.

## Most influential descendants
- K161303: dynaMX™ Compression Plate (2017), 1 descendant of its own
- K193345: Arthrex DynaNite Compression Plate (2020), 0 descendants of its own

## Indications for use
Fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulna, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.

Source page: https://510kreport.com/device/K143023
Methodology: https://510kreport.com/methodology