510(k) · Cleared
ClearedTrigen Retrograde Femoral, Supracondylar 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 30, 2005 as substantially equivalent to K981529 (Smith & Nephew, Inc., 1998) and 3 other predicates after a 17-day review. Its family tree reaches back 2 generations to 1995. 69 later devices descend from it.
- Decided
- Jun 30, 2005
- Review
- 17 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K951740 (1995). 8 ancestors in all. 69 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 1 generation backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- This deviceK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- Descendant · cites it directly · 60 of its ownK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 18 of its ownK111667 Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · Recalled
- Descendant · 3 generations on · 17 of its ownK131365 T2 Tibial Nailing SystemStryker Trauma AG · 2013 · Recalled
- Descendant · 2 generations on · 16 of its ownK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
- Descendant · 3 generations on · 15 of its ownK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · cites it directly60descendants
- K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · 2 generations on18descendants
- K131365T2 Tibial Nailing SystemStryker Trauma AG · 2013 · 3 generations on17descendants
- K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · 2 generations on16descendants
- K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −1 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| 0 (this device) | 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 |
| +2 | K111667 | Synthes Suprapatellar Insertion Instruments | Synthes (Usa) | 2011 | 1 |
| +3 | K131365 | T2 Tibial Nailing System | Stryker Trauma AG | 2013 | 4 |
| +2 | K102369 | Piccolo Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2011 | 1 |
| +3 | K111056 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2011 | 1 |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 9 | 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? (4)
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 (TdrGen®) Intramedullary Hip System; K983942, Smith & Nephew Intramedullary Nail System; K032722, TriGen… | 1998 |
| * | K983942 | Intramedullary Nail System, Locking Screw, Nail CapSummary page 1…aterial composition when compared to the predicate devices cleared under the following submissions: K981529, Smith & Nephew Titanium (TdrGen®) Intramedullary Hip System; K983942, Smith & Nephew Intramedullary Nail System; K032722, TriGen® Straight Humeral Nail; and K040212, TdGen® InterTAN Nails.… | 1998 |
| * | K032722 | Trigen Straight Humeral Nail SystemSummary page 1…evices cleared under the following submissions: K981529, Smith & Nephew Titanium (TdrGen®) Intramedullary Hip System; K983942, Smith & Nephew Intramedullary Nail System; K032722, TriGen® Straight Humeral Nail; and K040212, TdGen® InterTAN Nails.… | 2003 |
| * | K040212 | Trigen IntertanSummary page 1…ns: K981529, Smith & Nephew Titanium (TdrGen®) Intramedullary Hip System; K983942, Smith & Nephew Intramedullary Nail System; K032722, TriGen® Straight Humeral Nail; and K040212, TdGen® InterTAN Nails. Page 1of 1… | 2004 |
What descends from it? (69)
See all 696 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | 2006 | 60 |
| K070761 | Sanatmetal Nails and Pins | 2008 | 3 |
| K230761 | TRIGEN META-NAIL Nail System | 2023 | 2 |
| K192003 | Auxein Nailing System | 2020 | 2 |
| K210980 | Smith & Nephew Intramedullary Nail Systems | 2022 | 0 |
| K132830 | Distalock Tibial IM Nail System | 2014 | 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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K061019 (Smith & Nephew, Inc., 2006) has gone furthest, with 60 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 pathotogic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedultary nails are indicated for fixation of fractures…
Read the full statement (179 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 pathotogic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedultary nails are indicated for fixation of fractures that occur inand between the proximal and distal third of tong bones being treated.
Inaddition to the indications for interlocking intramedultary nails, devices that contain hotes/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; ipsilaterat femoral shaft/neck fractures; and intertrochanteric fractures.
Inaddition 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.
Intramedultary locking nails (i.e. TriGen® Nails) are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051557: Trigen Retrograde Femoral, Supracondylar and Tibial Nails.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051557
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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