# K961496: R.R.P.S. Radius Reconstrution Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Jun 28, 1996 after 71 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
No predicates in its family tree.
204 later devices descend from it; 2 cite it directly.
0 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Alta® Modular Trauma Small Bone Plating System: named in the summary without a submission number
- (no number) Synthes® Small Fragment and Mini Set: named in the summary without a submission number

## Most influential descendants
- K981283: Rogachefsky Distal Radius Plates (1998), 203 descendants of its own
- 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

## Indications for use
The system is intended for use in-internal fixation of small bones--primarily the distal radius in the forearm.

Source page: https://510kreport.com/device/K961496
Methodology: https://510kreport.com/methodology