510(k) · Cleared
ClearedOgmend® Implant Enhancement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Woven Orthopedic Technologies · QVI Screw Sleeve Bone Fixation Device, Spine
Cleared on Feb 27, 2023 as substantially equivalent to DEN180065 (Woven Orthopedic Technologies, LLC, 2020) after a 150-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Feb 27, 2023
- Review
- 150 days
- Class
- Class II
- Product code
- QVI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180065 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backDEN180065 OGmend Implant SystemWoven Orthopedic Technologies, LLC · 2020
- This deviceK223075 Ogmend® Implant Enhancement SystemWoven Orthopedic Technologies · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180065 | OGmend Implant System | Woven Orthopedic Technologies, LLC | 2020 | — |
| 0 (this device) | K223075 | Ogmend® Implant Enhancement System | Woven Orthopedic Technologies | 2023 | — |
Sources: FDA 510(k) 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 QVI? 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN180065 | OGmend Implant SystemSummary page 5…erile as a disposable, single-use device. The Inserter is compatible with sterilization by gamma radiation. PRIMARY PREDICATE DEVICE Ogmend® Implant Enhancement System (DEN180065). COMPARISON OF TECHNOLOGICAL CHARACTERISTICS The subject Ogmend® Implant is identical to the primary predicate in material, de… | 2020 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All QVI devicesQVI Screw Sleeve Bone Fixation Device, Spine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QVI
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QVI
Too few QVI 510(k)s in any year since 2007 to give a median.
Recalls per year · QVI
No recall names QVI since 2007.
Adverse event reports per year · QVI
No MAUDE report names QVI 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 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ogmend® Implant Enhancement System is intended to augment pedicle screw fixation when a screw has lost purchase due to screw loosening, back-out, or breakage. The Ogmend® Implant Enhancement System is for use with rigid, thoracolumbar pedicle screw systems where a screw is inserted posteriorly, through the pedicle, and into the vertebral body. The Ogmend® Implant Enhancement System is for use in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223075 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223075: Ogmend® Implant Enhancement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223075
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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