510(k) · Cleared
ClearedTrimed Radiocarpal Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
TriMed, Inc. · HRS Plate, Fixation, Bone
Cleared on Aug 19, 2011 as substantially equivalent to K042355 (Synthes (Usa), 2004) and 1 other predicate after a 326-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Aug 19, 2011
- Review
- 326 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000684 (2000). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 1 generation backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- This deviceK102785 Trimed Radiocarpal Fusion SystemTriMed, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK251945 TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK262032 TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed…TriMed, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −1 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| 0 (this device) | K102785 | Trimed Radiocarpal Fusion System | TriMed, Inc. | 2011 | — |
| +1 | K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | TriMed, Inc. | 2025 | — |
| +2 | K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist… | TriMed, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K042355 | Synthes (Usa) LCP Wrist Fusion PlatesSummary page 1…ion, Bone HRS - Section 888.3040 Predicate Devices: K042355 - Synthes LCP Wrist Fusion System… | 2004 |
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 1…Synthes LCP Wrist Fusion System K011335 - Synthes One-Third Tubular DCL Plate Indications for Use:… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | 2025 | 1 |
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 11 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K251945 (TriMed, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K042355.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 TriMed Radiocarpal Fusion System plates and screws are intended for wrist arthrodesis and fixation of fractures of other small bones
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102785: Trimed Radiocarpal Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102785
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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