# K201229: Intai Anatomic Locking Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Intai Technology Corporation
- Decided: Mar 11, 2022 after 673 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
Longest line of descent: 7 generations back to K962616 (1996). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP), Synthes (Usa) (2009) Summary page 4.
- K073186: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2007) Summary page 4.
- K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 4.
- K040022: Stryker Leibinger Universal Distal Radius System, Stryker Leibinger (2004) Summary page 4.
- K082078: Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna Plates, Zimmer, Inc. (2008) Summary page 4.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 4.
- K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 4.
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 4.
- K073460: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 4.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 4.
- K033805: Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates, Synthes (Usa) (2004) Summary page 4.
- K093928: Synthes 3.5MM Quadrilateral Surface Plates, Synthes (Usa) (2010) Summary page 4.
- K042377: Synthes Low Profile Reconstruction Plates, Synthes (Usa) (2004) Summary page 4.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 4.
- K060710: Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws, Zimmer, Inc. (2006) Summary page 5.

## Indications for use
The Intai Anatomy Locking Plate and Screw System is provided non-sterile. The system is intended for use in fixation of fractures to the various bones, including: clavicle, radius, ulna, humerus, femur, tibia, fibula, and acetabulum for adults. This system is not indicated for use in the spine.

Source page: https://510kreport.com/device/K201229
Methodology: https://510kreport.com/methodology