# K061748: Fragment Plate System

- Pathway: 510(k) (Special)
- Applicant: Hand Innovations, LLC
- Decided: Jul 17, 2006 after 26 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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 K041081 (2004). 1 ancestor in all.
157 later devices descend from it; 7 cite it directly.
0 of 159 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041081: Fragment Plate System, Screws, Pins and K-Wires, Hand Innovations, Inc. (2004) Summary page 1.

## Most influential descendants
- K101240: Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 (2010), 154 descendants of its own
- K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws (2012), 97 descendants of its own
- K121651: Ortholoc 3DI Midfoot/Flatfoot System (2012), 95 descendants of its own
- K132886: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (2014), 46 descendants of its own
- K140814: Evos Mini-Fragment Plating System (2014), 32 descendants of its own

## Indications for use
The Fragment Plate System is intended for essentially non load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomax, illofacial skeleton.

Source page: https://510kreport.com/device/K061748
Methodology: https://510kreport.com/methodology