# K022325: Normed Titanium Osteotomy Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomedics, Inc.
- Decided: Sep 9, 2002 after 54 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
521 later devices descend from it; 5 cite it directly.
0 of 522 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 no predicate by number.

## Most influential descendants
- K061808: Darco Locking Bone Plate System (2006), 410 descendants of its own
- K073624: Modular Foot System (2008), 342 descendants of its own
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology (2010), 339 descendants of its own
- K081513: Merete 3.0 and 3.5 MM Locking Screws (2008), 256 descendants of its own
- K040907: Arthrex Small Fragment Plates and Screws (2004), 249 descendants of its own

## Recalls of this device
- Apr 14, 2009 · Not classified · Z-1524-2009: Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat 

## Indications for use
The Normed Titanium Osteotomy Plating System intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes skeleton. The system can be used in both adult and pediatric patients.

Source page: https://510kreport.com/device/K022325
Methodology: https://510kreport.com/methodology