510(k) · Cleared
ClearedMICRONAIL Distal Radius System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 10, 2015 as substantially equivalent to K040938 (Wrightmedicaltechnologyinc, 2004) after a 27-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- Feb 10, 2015
- Review
- 27 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040938 (2004). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K260115DRIM-Nail System41Medical AG · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040938 | Radial Nail System | Wrightmedicaltechnologyinc | 2004 | — |
| 0 (this device) | K150073 | MICRONAIL Distal Radius System | Wrightmedicaltechnologyinc | 2015 | — |
| +1 | K260115 | DRIM-Nail System | 41Medical AG | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 HSB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K040938 | Radial Nail SystemSummary page 5…Reference: 21 CFR 888.3020- Class II Device Product Code, Device Panel: HSB - Orthopedic 3. Predicate Device: K040938 Radial Nail System 4. Device Description The MICRONAIL™ Distal Radius System was cleared (K040938) as a s… | 2004 |
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 |
|---|---|---|---|
| K260115 | DRIM-Nail System | 2026 | 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?
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The MICRONAIL® Intramedullary Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable: • Joint destruction and/or subluxation visible on x-ray; • 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…
Read the full statement (105 words)
The MICRONAIL® Intramedullary Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:
• Joint destruction and/or subluxation visible on x-ray;
• 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;
• Comminuted articular fractures, shearing fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150073: MICRONAIL Distal Radius System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150073
Report an extraction error
Are you the manufacturer?
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