# K110392: PSM Lomas / Benefit Screws

- Pathway: 510(k) (Traditional)
- Applicant: Psm Medical Solutions
- Decided: Dec 14, 2011 after 306 days
- Product code: OAT (Implant, Endosseous, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894844 (1990). 24 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042345: Lin/Liou Orthodontic Mini Anchor System (Lomas), Mondeal Medical Systems GmbH (2005) Summary page 1.
- K050257: Lin/Liou Orthodontic Mini Anchor System (Lomas) (Sterile), Mondeal Medical Systems GmbH (2005) Summary page 1.
- K090476: Syntec Orthodontic Mini Screw, Syntec Scientific Corp. (2009) Summary page 1.
- K023067: Imtec Sendax Mdi ORTHO6 and ORTHO8, Imtec Corp. (2002) Summary page 1.
- K042289: Mdi Ortho, Imtec Corp. (2004) Summary page 1.

## Most influential descendants
- K161335: Dual Top Screw System (2017), 3 descendants of its own
- K242944: Leone Orthodontic Implant TAD (Temporary Anchorage Device) (2025), 0 descendants of its own
- K231913: T-FIT (2024), 0 descendants of its own
- K210559: ATOZ Mini-Screw (2021), 0 descendants of its own
- K191041: Orthodontic Fixation Screw [Smart Anchor Miniscrew] (2020), 0 descendants of its own

## Indications for use
The PSM LOMAS / BENEFIT Screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.

Source page: https://510kreport.com/device/K110392
Methodology: https://510kreport.com/methodology