# K253906: Xpert Hand

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Mar 11, 2026 after 96 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: 12 generations back to K962616 (1996). 112 ancestors in all.
No later device cites it as a predicate yet.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062498: Profyle System, Howmedica Osteonics Corp. (2006) Summary page 5.
- K150099: Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws), Synthes (USA) Products, LLC (2015) Summary page 5.
- K141527: Depuy Synthes Variable Angle Locking Hand System, Synthes USA (2015) Summary page 5.
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 5.

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

Source page: https://510kreport.com/device/K253906
Methodology: https://510kreport.com/methodology