510(k) · Cleared
ClearedTRIGEN META-NAIL Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JDS Nail, Fixation, Bone
Cleared on Jun 14, 2023 as substantially equivalent to K051557 (Smith & Nephew, Inc., 2005) and 2 other predicates after an 86-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Jun 14, 2023
- Review
- 86 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K951740 (1995). 10 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 3 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 2 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- 1 generation backK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- This deviceK230761 TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253517 Reselute Tibial NailReselute, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK243608 TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc. · 2025
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 |
|---|---|---|---|---|---|
| −4 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −3 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −2 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| −1 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
| 0 (this device) | K230761 | TRIGEN META-NAIL Nail System | Smith & Nephew, Inc. | 2023 | — |
| +1 | K253517 | Reselute Tibial Nail | Reselute, Inc. | 2026 | — |
| +1 | K243608 | TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 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 JDS? 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 JDS device
- #1 K243608 TRIGEN Stable Lock Nut & Washerscore 11.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial NailsSummary page 4…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K051557 TRIGEN Retrograde Femoral, Supracondylar And Tibial Nails JDS K061019 TRIGEN Meta-Nail Retr… | 2005 |
| * | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial NailsSummary page 4…edicate Trade Name (Primary Predicate is listed first) Product Code K051557 TRIGEN Retrograde Femoral, Supracondylar And Tibial Nails JDS K061019 TRIGEN Meta-Nail Retrograde Femoral And Tibial Nails JDS K981529 Titanium Intramedulla… | 2006 |
| * | K981529 | Titanium Intramedullary Nail, Titanium Locking ScrewSummary page 4…TRIGEN Retrograde Femoral, Supracondylar And Tibial Nails JDS K061019 TRIGEN Meta-Nail Retrograde Femoral And Tibial Nails JDS K981529 Titanium Intramedullary Nail, Titanium Locking Screw JDS Device Description Summary… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K253517 (Reselute, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K051557.
How does its category compare?
All JDS devicesJDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JDS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDS
146in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDS
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDS
497in 2025
MAUDE reports naming product code JDS, 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 | 2 | — | 0 | 161 |
| 2008 | 1 | — | 0 | 169 |
| 2009 | 0 | — | 3 | 160 |
| 2010 | 0 | — | 2 | 70 |
| 2011 | 1 | — | 0 | 104 |
| 2012 | 0 | — | 0 | 195 |
| 2013 | 1 | — | 4 | 284 |
| 2014 | 0 | — | 0 | 388 |
| 2015 | 1 | — | 0 | 316 |
| 2016 | 0 | — | 0 | 506 |
| 2017 | 0 | — | 1 | 287 |
| 2018 | 0 | — | 0 | 320 |
| 2019 | 0 | — | 0 | 490 |
| 2020 | 3 | 106 | 1 | 643 |
| 2021 | 0 | — | 0 | 630 |
| 2022 | 0 | — | 0 | 589 |
| 2023 | 1 | — | 0 | 357 |
| 2024 | 3 | 146 | 0 | 466 |
| 2025 | 1 | — | 2 | 497 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TRIGEN META-NAIL Retrograde Femoral Nail is indicated for fractures of the femur including stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures.
The TRIGEN META-NAIL Antegrade Tibial Nail is indicated for stable and unstable fractures of the proximal and distal third of the tibia, including the shaft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230761: TRIGEN META-NAIL 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/K230761
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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