510(k) · Cleared
ClearedIntramedullary Nail System, Locking Screw, Nail Cap
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 Dec 4, 1998 after a 29-day review. The FDA summary names its predicate without a number. 198 later devices descend from it.
- Decided
- Dec 4, 1998
- Review
- 29 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 0
198 later devices descend from it, 18 citing it directly.
- This deviceK983942 Intramedullary Nail System, Locking Screw, Nail CapSmith & Nephew, Inc. · 1998
- Descendant · cites it directly · 121 of its ownK040212 Trigen IntertanSmith & Nephew, Inc. · 2004 · Recalled
- Descendant · cites it directly · 100 of its ownK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 69 of its ownK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- Descendant · 2 generations on · 60 of its ownK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- Descendant · cites it directly · 41 of its ownK023115 Ace VersanailDePuy Orthopaedics, Inc. · 2002
Showing 5 of 198 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 198 · See all- K040212Trigen IntertanSmith & Nephew, Inc. · 2004 · cites it directly121descendants
- K032722Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003 · cites it directly100descendants
- K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005 · cites it directly69descendants
- K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · 2 generations on60descendants
- K023115Ace VersanailDePuy Orthopaedics, Inc. · 2002 · cites it directly41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983942 | Intramedullary Nail System, Locking Screw, Nail Cap | Smith & Nephew, Inc. | 1998 | — |
| +1 | K040212 | Trigen Intertan | Smith & Nephew, Inc. | 2004 | 6 |
| +1 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| +1 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| +2 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
| +1 | K023115 | Ace Versanail | DePuy Orthopaedics, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 9 | 0 |
| 2012 | 8 | 0 |
| 2013 | 10 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 12 | 0 |
| 2021 | 7 | 0 |
| 2022 | 13 | 0 |
| 2023 | 11 | 0 |
| 2024 | 17 | 0 |
| 2025 | 19 | 0 |
| 2026 | 19 | 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? (1)
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 |
|---|---|---|---|
| * | — | Trimax Nail System Named without a submission number |
What descends from it? (198)
See all 19818 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040212 | Trigen Intertan | 2004 | 121 |
| K032722 | Trigen Straight Humeral Nail System | 2003 | 100 |
| K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | 2005 | 69 |
| K023115 | Ace Versanail | 2002 | 41 |
| K091425 | Quantum M Composite Nailing System | 2010 | 31 |
| K102369 | Piccolo Composite Nailing System | 2011 | 16 |
| K050882 | Newdeal Ankle Nail | 2005 | 15 |
| K040462 | Trigen Trochanteric Antegrade Nail | 2004 | 13 |
| K040656 | Modification to Smith & Nephew Intramedullary Hip Screw | 2004 | 9 |
| K040929 | Trigen Adolescent Tan | 2004 | 9 |
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?
- Of its descendants, K040212 (Smith & Nephew, Inc., 2004) has gone furthest, with 121 descendants of its own.
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 (284 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 the 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 are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach 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.
Indications for the ReVision Nail include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.
Knee Fusion Nails are intended for intramedullary knee arthrodesis.
Ender Nails are indicated as follows: fracture of the neck, trochanteric, and subtrochanteric region of the femur; distal femoral fractures with a distal fragment 10 cm or longer; tibial shaft fractures; and proximal humeral fractures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983942 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983942: Intramedullary Nail System, Locking Screw, Nail Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983942
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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