# K061917: Distal Radius Locking Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Aug 28, 2006 after 53 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 K962616 (1996). 8 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030198: Hand Innovations, Inc. Distal Radius Fracture Repair System, Hand Innovations, Inc. (2003) Summary page 2.
- K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 2.
- K955472: Ace Humerus & Radius Plates, Ace Medical Co. (1996) Summary page 2.

## Most influential descendants
- K130774: Universal Distal Radius System (2013), 5 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K061917
Methodology: https://510kreport.com/methodology