# K981283: Rogachefsky Distal Radius Plates

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Jun 10, 1998 after 63 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: 1 generation back to K885250 (1989). 2 ancestors in all.
203 later devices descend from it; 1 cites it directly.
0 of 206 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961496: R.R.P.S. Radius Reconstrution Plating System, Howmedica, Inc. (1996) Summary page 1.
- K885250: Alta Tibial/Upper Extremity Metaphyseal Plate Sys, Howmedica Corp. (1989) Summary page 1.

## Most influential descendants
- K040022: Stryker Leibinger Universal Distal Radius System (2004), 202 descendants of its own
- 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

## Indications for use
The Rogachefsky Distal Radius Plates are intended for use in internal fixation of fractures of the distal radius.

Source page: https://510kreport.com/device/K981283
Methodology: https://510kreport.com/methodology