# K213214: Xpert Wrist

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Nov 24, 2021 after 56 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: 16 generations back to K962616 (1996). 185 ancestors in all.
No later device cites it as a predicate yet.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170843: Alians Fragment Specific, Newclip Technics (2017) Summary page 5.
- K060041: Trimed Bone Plates, TriMed, Inc. (2006) Summary page 5.
- K042355: Synthes (Usa) LCP Wrist Fusion Plates, Synthes (Usa) (2004) Summary page 5.
- K142906: APTUS Wrist 2.5 System, Medartis AG (2015) Summary page 5.
- K172170: APTUS (R) Wrist 2.5 System, Medartis AG (2017) Summary page 5.
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 5.
- K140372: Fragment Plate System, Skeletal Dynamics, LLC (2014) Summary page 5.
- K182492: Geminus Volar Distal Radius Plate System, Skeletal Dynamics, LLC (2018) Summary page 5.
- K131764: Acumed Wrist Spanning Plate, Acumed, LLC (2013) Summary page 5.
- K143061: Activ Ankle Locking Plating System, Newclip Technics (2015) Summary page 5.
- K173641: Activ Ankle, Newclip Technics (2018) Summary page 5.
- K141548: High Tibial Osteotomy System, Newclip Technics (2015) Summary page 5.

## Indications for use
The implants of the Xpert Wrist range are intended for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults.

Source page: https://510kreport.com/device/K213214
Methodology: https://510kreport.com/methodology