510(k) · Cleared
ClearedTRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture 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 Sep 20, 2024 as substantially equivalent to K061019 (Smith & Nephew, Inc., 2006) and 1 other predicate after a 255-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Sep 20, 2024
- Review
- 255 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K951740 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK240061 TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc. · 2024
View 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) | K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System | Smith & Nephew, Inc. | 2024 | — |
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 |
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 |
|---|---|---|---|
| * | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial NailsSummary page 6…terial of the subject devices are similar to that of the primary predicate Smith & Nephew systems cleared under the premarket notifications TRIGEN META-NAIL Tibial Nail (K061019, S.E. 06/06/06) and TRIGEN INTERTAN (K040212, S.E. 02/20/04). The subject devices, including the nailing system accessories, are… | 2006 |
| * | K040212 | Trigen IntertanSummary page 6…that of the primary predicate Smith & Nephew systems cleared under the premarket notifications TRIGEN META-NAIL Tibial Nail (K061019, S.E. 06/06/06) and TRIGEN INTERTAN (K040212, S.E. 02/20/04). The subject devices, including the nailing system accessories, are also technologically similar to the reference… | 2004 |
| † | K172157 | DePuy Synthes Femoral Recon Nail System | 2017 |
| † | K111025 | Trigen Low Profile Bone Screw | 2011 |
| † | K161264 | TRIGEN Low Profile Bone Screws | 2016 |
| † | K981529 | Titanium Intramedullary Nail, Titanium Locking Screw | 1998 |
| † | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) | 1999 |
| † | K162078 | EVOS Small Fragment Plating System | 2016 |
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?
- The line of descent spans 29 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.
- 12 other devices also cite its predicate K061019.
How does its category compare?
All JDS devicesJDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
TRIGEN MAX Tibial Nail System: The TRIGEN MAX Tibial Nail is indicated for stable and unstable fractures that occur in and between the proximal and distal third of the tibia, including the shaft. INTERTAN MAX Hip Fracture Nail System: The INTERTAN MAX Nails are indicated for fractures of the femur including: * Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fracture…
Read the full statement (100 words)
TRIGEN MAX Tibial Nail System:
The TRIGEN MAX Tibial Nail is indicated for stable and unstable fractures that occur in and between the proximal and distal third of the tibia, including the shaft.
INTERTAN MAX Hip Fracture Nail System:
The INTERTAN MAX Nails are indicated for fractures of the femur including:
* Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fracture; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures
* Polytrauma and multiple fractures
* Prophylactic nailing of impending pathologic fractures
* Reconstruction following tumor resection and grafting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240061: TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture 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/K240061
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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