# K091619: Anglefix T Locking Plate, Models AF-001 (Plate), ST-1 (Locking Screw)

- Pathway: 510(k) (Traditional)
- Applicant: Anglefix
- Decided: Sep 8, 2009 after 97 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 K033995 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060613: Variax Locking Plate System, Howmedica Osteonics Corp. (2006)
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 1.
- K061012: Axsos Plus Locking Plate System, Howmedica Osteonics Corp. (2006)

## Indications for use
The AngleFix T Locking Plate is indicated for temporary stabilization of long bone fractures including: * Proximal and distal fractures including joint fractures of the humerus, tibia and other long bones * Metaphyseal, supracondylar, peri-articular, intra-articular,. and intra-articular condylar fractures * Diaphyseal fractures * Ankle fractures * Simple, comminuted and depression fractures * Non-unions and malunions * Osteotomies and bone reconstruction * Fractures in normal or osteoporotic bone

Source page: https://510kreport.com/device/K091619
Methodology: https://510kreport.com/methodology