De Novo · Granted
GrantedRemeOs™ Screw LAG Solid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioretec, Ltd. · QJD Absorbable Metallic Bone Fixation Fastener
Granted on Mar 29, 2023 as a new device type through De Novo after a 329-day review.
- Decided
- Mar 29, 2023
- Review
- 329 days
- Class
- Class II
- Product code
- QJD
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QJD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QJD devicesQJD Absorbable Metallic Bone Fixation Fastener: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QJD
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QJD
Too few QJD 510(k)s in any year since 2007 to give a median.
Recalls per year · QJD
No recall names QJD since 2007.
Adverse event reports per year · QJD
No MAUDE report names QJD since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220030 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220030: RemeOs™ Screw LAG Solid.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220030
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026