# K200987: LTJ Screws and Washer

- Pathway: 510(k) (Traditional)
- Applicant: Azurmeds, Inc.
- Decided: Sep 22, 2020 after 160 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: 11 generations back to K962616 (1996). 83 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124027: Monster Screw System, Apogee Orthosolutions (2013) Summary page 4.

## Most influential descendants
- K210268: LTJ Screws and Washer (2021), 0 descendants of its own

## 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/K200987
Methodology: https://510kreport.com/methodology