# K130774: Universal Distal Radius System

- Pathway: 510(k) (Special)
- Applicant: Newclip Technics
- Decided: Jun 19, 2013 after 91 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: 9 generations back to K962616 (1996). 40 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061917: Distal Radius Locking Plating System, Newclip Technics (2006) Summary page 1.
- K100944: Clavicle Locking Plate System, Newclip Technics (2010) Summary page 1.
- K102694: 2.4MM VA-LCP Dorsal Distal Radius Plates, Synthes (Usa) (2010) Summary page 1.
- K102998: Congruent Bone Plate  System, Acumed, LLC (2011) Summary page 1.
- K090053: Aptus 2.0 Radial Head System, Medartis AG (2009) Summary page 1.

## Most influential descendants
- K142502: Alians Ulna Locking Plating System (2014), 2 descendants of its own
- K211592: Avanti Orthopaedics Ulnar Shortening System (2021), 1 descendant of its own
- K170843: Alians Fragment Specific (2017), 1 descendant of its own
- K261145: Avanti Distal Elbow ORIF System (2026), 0 descendants of its own
- K213214: Xpert Wrist (2021), 0 descendants of its own

## Indications for use
The Universal Distal Radius System is intended for the fixation of intra and extra-articular fractures as well as distal radius osteotomy.

Source page: https://510kreport.com/device/K130774
Methodology: https://510kreport.com/methodology