# K063095: Humerus Locking Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Dec 22, 2006 after 73 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: 3 generations back to K000684 (2000). 12 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051728: Modification to Shoulder Fixation System, Hand Innovations, LLC (2005)
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 2.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 2.
- K060798: Stryker Plating System, Howmedica Osteonics Corp. (2006) Summary page 2.

## Most influential descendants
- K141548: High Tibial Osteotomy System (2015), 3 descendants of its own
- K173746: Activmotion Range (2018), 1 descendant of its own
- K241539: Activmotion S (2024), 0 descendants of its own
- K213214: Xpert Wrist (2021), 0 descendants of its own

## Indications for use
The Humerus Locking Plating System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Source page: https://510kreport.com/device/K063095
Methodology: https://510kreport.com/methodology