De Novo · Granted
GrantedOGmend Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Woven Orthopedic Technologies, LLC · QAC Screw Sleeve Bone Fixation Device
Granted on May 1, 2020 as a new device type through De Novo after a 505-day review. 1 later device descends from it.
- Decided
- May 1, 2020
- Review
- 505 days
- Class
- Class II
- Product code
- QAC
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN180065 OGmend Implant SystemWoven Orthopedic Technologies, LLC · 2020
- Descendant · cites it directly · 0 of its ownK223075 Ogmend® Implant Enhancement SystemWoven Orthopedic Technologies · 2023
Most influential descendants
Showing 1 of 1 · See all- K223075Ogmend® Implant Enhancement SystemWoven Orthopedic Technologies · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180065 | OGmend Implant System | Woven Orthopedic Technologies, LLC | 2020 | — |
| +1 | K223075 | Ogmend® Implant Enhancement System | Woven Orthopedic Technologies | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 QAC? 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223075 | Ogmend® Implant Enhancement System | 2023 | 0 |
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.
What does this lineage say?
- Of its descendants, K223075 (Woven Orthopedic Technologies, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QAC devicesQAC Screw Sleeve Bone Fixation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QAC
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · QAC
Too few QAC 510(k)s in any year since 2007 to give a median.
Recalls per year · QAC
No recall names QAC since 2007.
Adverse event reports per year · QAC
No MAUDE report names QAC 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 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OGmend® Implant System is for the use with screws as part of a fracture fixation plate system in long bones in rescue scenarios where the screw has lost purchase due to screw loosening, back out, or breakage and the stability of the plate construct is at risk. The OGmend® Implant System is for use in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180065 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180065: OGmend Implant System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180065
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026