# K040022: Stryker Leibinger Universal Distal Radius System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger
- Decided: Mar 12, 2004 after 65 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: 2 generations back to K885250 (1989). 5 ancestors in all.
202 later devices descend from it; 12 cite it directly.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981283: Rogachefsky Distal Radius Plates, Howmedica, Inc. (1998) Summary page 1.
- K961496: R.R.P.S. Radius Reconstrution Plating System, Howmedica, Inc. (1996) Summary page 1.
- K014263: Newgen/Universal Mandibular System, Stryker Instruments (2002) Summary page 1.

## Most influential descendants
- K051567: Aptus Titanium Osteosynthesis System (2005), 157 descendants of its own
- K062498: Profyle System (2006), 81 descendants of its own
- K100271: Vari AX Distal Radius Line Extensions of XXL Plates (2010), 80 descendants of its own
- K103332: Aptus Ulna Plates (2011), 71 descendants of its own
- K073527: Variax Elbow System (2008), 61 descendants of its own

## Indications for use
Stryker® Leibinger Universal Distal Radius System is intended for use in internal fixation of the small bone fractures, primarily including distal radius fractures. Examples of these distal radius fractures include but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal or orthogonal application.

Source page: https://510kreport.com/device/K040022
Methodology: https://510kreport.com/methodology