510(k) · Cleared
Recalled · Class II · 2020Trigen Meta-Nail Retrograde Femoral and Tibial Nails
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 6, 2006 as substantially equivalent to K981529 (Smith & Nephew, Inc., 1998) and 1 other predicate after a 54-day review. Its family tree reaches back 3 generations to 1995. 60 later devices descend from it. It has been recalled once.
- Decided
- Jun 6, 2006
- Review
- 54 days
- Class
- Class II
- Product code
- JDS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K951740 (1995). 9 ancestors in all. 60 later devices descend from it, 13 citing it directly.
- Root · 3 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 2 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 1 generation backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- This deviceK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006
- Descendant · cites it directly · 18 of its ownK111667 Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · Recalled
- Descendant · 2 generations on · 17 of its ownK131365 T2 Tibial Nailing SystemStryker Trauma AG · 2013 · Recalled
- Descendant · cites it directly · 16 of its ownK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
- Descendant · 2 generations on · 15 of its ownK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
- Descendant · 2 generations on · 14 of its ownK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · cites it directly18descendants
- K131365T2 Tibial Nailing SystemStryker Trauma AG · 2013 · 2 generations on17descendants
- K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · cites it directly16descendants
- K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · 2 generations on15descendants
- K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −2 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −1 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| 0 (this device) | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | — |
| +1 | K111667 | Synthes Suprapatellar Insertion Instruments | Synthes (Usa) | 2011 | 1 |
| +2 | K131365 | T2 Tibial Nailing System | Stryker Trauma AG | 2013 | 4 |
| +1 | K102369 | Piccolo Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2011 | 1 |
| +2 | K111056 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2011 | 1 |
| +2 | K123810 | Piccolo Composite Ankle Arthrodesis Nailing System | CarboFix Orthopedics, Ltd. | 2013 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 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 |
|---|---|---|---|
| * | K981529 | Titanium Intramedullary Nail, Titanium Locking ScrewSummary page 1…in indications for use, design features, operational principles, and material composition when compared to the predicate devices cleared under the following submissions: K981529, Smith & Nephew Titanium (TdGen®) Intramedullary Nail System and K051557, TriGen® Retrograde Femoral, Supracondylar, and Tibial N… | 1998 |
| * | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial NailsSummary page 1…rial composition when compared to the predicate devices cleared under the following submissions: K981529, Smith & Nephew Titanium (TdGen®) Intramedullary Nail System and K051557, TriGen® Retrograde Femoral, Supracondylar, and Tibial Nails.… | 2005 |
What descends from it? (60)
See all 6013 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111667 | Synthes Suprapatellar Insertion Instruments | 2011 | 18 |
| K102369 | Piccolo Composite Nailing System | 2011 | 16 |
| K092748 | Sureshot Tan Nails and Accessories | 2010 | 4 |
| K070444 | Aos Tibial Nail | 2007 | 4 |
| K150867 | Affixus Tibial Nailing System | 2015 | 3 |
| K113695 | Ellipse Precice Trauma Nail System | 2012 | 3 |
| K230761 | TRIGEN META-NAIL Nail System | 2023 | 2 |
| K171108 | AUTOBAHN Nailing System | 2017 | 2 |
| K090091 | Olecranail Intramedullary Fixation System | 2009 | 1 |
| K243608 | TRIGEN Stable Lock Nut & Washer | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2020 | Class II | Z-2685-2020 | Reprocessing Controls | A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve. |
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 1.7 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K111667 (Synthes (Usa), 2011) has gone furthest, with 18 descendants of its own.
- 15 other devices also cite its predicate K981529.
How does its category compare?
All JDS devicesJDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures…
Read the full statement (182 words)
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach (i.e. Retrograde/Tibial and Supracondylar Nails) are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants.
Intramedullary locking nails (i.e. TriGen® Nails) are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061019 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061019
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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