510(k) · Cleared
Recalled · Class II · 2013Titanium Intramedullary Nail, Titanium Locking Screw
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 Jul 9, 1998 after a 71-day review. The FDA summary names its predicate without a number. 211 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 9, 1998
- Review
- 71 days
- Class
- Class II
- Product code
- JDS
- Recalls
- 2
- Predicates
- 0
211 later devices descend from it, 16 citing it directly.
- This deviceK981529 Titanium Intramedullary Nail, Titanium Locking ScrewSmith & 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 · 70 of its ownK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- Descendant · cites it directly · 69 of its ownK051557 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
Showing 5 of 211 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 211 · See all- K040212Trigen IntertanSmith & Nephew, Inc. · 2004 · cites it directly121descendants
- K032722Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003 · cites it directly100descendants
- K013563Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · cites it directly70descendants
- K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005 · cites it directly69descendants
- K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · cites it directly60descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981529 | Titanium Intramedullary Nail, Titanium Locking Screw | 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 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 8 | 0 |
| 2010 | 5 | 0 |
| 2011 | 9 | 0 |
| 2012 | 8 | 0 |
| 2013 | 10 | 0 |
| 2014 | 8 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 11 | 0 |
| 2018 | 15 | 0 |
| 2019 | 10 | 0 |
| 2020 | 13 | 0 |
| 2021 | 7 | 0 |
| 2022 | 13 | 0 |
| 2023 | 13 | 0 |
| 2024 | 17 | 0 |
| 2025 | 19 | 0 |
| 2026 | 17 | 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? (6)
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 Antegrade and Retrograde Nails Named without a submission number | |
| * | — | Kuntscher Nail Named without a submission number | |
| * | — | Aim Antegrade Femoral, Retrograde Femoral and Tibial Nails Named without a submission number | |
| * | — | Unreamed Femoral (URFN) and Tibial Nails Named without a submission number | |
| * | — | Retrograde Femoral Nail Named without a submission number | |
| * | — | Ace ART Femoral Nail Named without a submission number |
What descends from it? (211)
See all 21116 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 |
| K013563 | Long Trochanteric Nail System | 2001 | 70 |
| K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | 2005 | 69 |
| K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | 2006 | 60 |
| K040462 | Trigen Trochanteric Antegrade Nail | 2004 | 13 |
| K040656 | Modification to Smith & Nephew Intramedullary Hip Screw | 2004 | 9 |
| K040929 | Trigen Adolescent Tan | 2004 | 9 |
| K111025 | Trigen Low Profile Bone Screw | 2011 | 5 |
| K092748 | Sureshot Tan Nails and Accessories | 2010 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2013 | Class II | Z-0943-2013 | Labeling mix-ups | 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label. |
| Feb 7, 2013 | Class II | Z-0944-2013 | Labeling mix-ups | 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label. |
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 (173 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 (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shafi/neck fractures; and intertrochanteric fractures.
In addition to the 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.
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/K981529 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981529: Titanium Intramedullary Nail, Titanium Locking Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981529
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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