# DEN220030: RemeOs™ Screw LAG Solid

- Pathway: De Novo (Direct)
- Applicant: Bioretec, Ltd.
- Decided: Mar 29, 2023 after 329 days
- Product code: QJD (Absorbable Metallic Bone Fixation Fastener)
- Device class: 2
- Regulation: 21 CFR 888.3041
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
RemeOs™ Screw LAG Solid is intended for the use in traumatic and orthopedic surgery for the fixation of bone fractures (osteosynthesis) and for the fixation after osteotomies, e.g., for the correction of deformities or malalignments. The absorbable implants serve as temporary fixation and stabilization by osteosynthesis of bone fractures and osteotomies until bony fusion has occurred. The RemeOs™ Screw LAG Solid is intended to be used for skeletally mature adults. The RemeOs™ Screw LAG Solid is indicated for the fixation of the medial malleolus.

Source page: https://510kreport.com/device/DEN220030
Methodology: https://510kreport.com/methodology