# K041081: Fragment Plate System, Screws, Pins and K-Wires

- Pathway: 510(k) (Traditional)
- Applicant: Hand Innovations, Inc.
- Decided: Jul 1, 2004 after 66 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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.
257 later devices descend from it; 3 cite it directly.
0 of 258 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) Distal Volar Fracture Repair System: named in the summary without a submission number

## Most influential descendants
- K061748: Fragment Plate System (2006), 157 descendants of its own
- K051567: Aptus Titanium Osteosynthesis System (2005), 157 descendants of its own
- 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

## Recalls of this device
- Jun 23, 2014 · Class II · Z-2212-2014: The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck.

## 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 reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.

Source page: https://510kreport.com/device/K041081
Methodology: https://510kreport.com/methodology