# K210268: LTJ Screws and Washer

- Pathway: 510(k) (Special)
- Applicant: Azurmeds, Inc.
- Decided: Feb 26, 2021 after 25 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962616 (1996). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200987: LTJ Screws and Washer, Azurmeds, Inc. (2020) Summary page 4.

## Indications for use
The LTJ Screws (3.75mm solid and 4.5mm cannulated) are intended to be used in skeletally mature patient as stand-alone bone screws for bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device. Optional washers are available for the 3.75 solid screws.

Source page: https://510kreport.com/device/K210268
Methodology: https://510kreport.com/methodology