510(k) · Cleared
ClearedEmerge Medical Distal Radius Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emerge Medical · HRS Plate, Fixation, Bone
Cleared on Mar 13, 2014 as substantially equivalent to K091644 (Synthes (Usa), 2009) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Mar 13, 2014
- Review
- 57 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K012114 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK012114 Synthes Locking Distal Radius Plating SystemSynthes (Usa) · 2001 · Recalled
- This deviceK140107 Emerge Medical Distal Radius SetEmerge Medical · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012114 | Synthes Locking Distal Radius Plating System | Synthes (Usa) | 2001 | 3 |
| 0 (this device) | K140107 | Emerge Medical Distal Radius Set | Emerge Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K091644 | Synthes (Usa) 2.4MM LCP Volar Column Distal Radius PlatesSummary page 2…icate Devices _________ 510k Trade or Proprietary or Model Name K091644 2.4mmnLCP Volar Column Distal Manufacturer Radius… | 2009 |
| * | K012114 | Synthes Locking Distal Radius Plating SystemSummary page 2…2.4mmnLCP Volar Column Distal Manufacturer Radius Synthes _____________ Plates _K0121 14 Locking Distal Radius Plating System Sthes PERFORMANCE DATA Static and Dynamic Bending of the Emerge Medica… | 2001 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 4 other devices also cite its predicate K091644.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Emerge Medical Distal Radius Set is intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius and other small bones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140107: Emerge Medical Distal Radius Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140107
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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