510(k) · Cleared
ClearedDRIM-Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Sep 11, 2026 as substantially equivalent to K150073 (Wrightmedicaltechnologyinc, 2015) after a 240-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Sep 11, 2026
- Review
- 240 days
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040938 (2004). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 this category? 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 |
|---|---|---|---|
| * | K150073 | MICRONAIL Distal Radius SystemSummary page 5…es: HSB, Rod, fixation, intramedullary and accessories Primary Predicate: Wright Medical Technology, Inc. MICRONAIL® Distal Radius System (K150073) Reference Devices: Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System (K081452/K082148)… | 2015 |
| † | K081452 | Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System | 2008 |
| † | K082148 | Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension | 2008 |
| † | K193554 | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System | 2020 |
| † | K243308 | Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA… | 2024 |
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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
- None of the 2 ancestors has a recall.
What is it indicated for?
The DRIM-Nail System is intended to be used for the fixation of unstable distal radius fractures of skeletally mature patients in which closed reduction is not suitable:
• Failed fracture fixation with or without bone graft;
• Osteotomy and repair of distal radius malunion with or without bone graft;
• Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260115: DRIM-Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260115
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026