510(k) · Cleared
ClearedTRIGEN Stable Lock Nut & Washer
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 12, 2025 as substantially equivalent to K983942 (Smith & Nephew, Inc., 1998) and 4 other predicates after a 202-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Jun 12, 2025
- Review
- 202 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K981529 (1998). 20 ancestors in all, the oldest K951740 (1995). No later device cites it as a predicate yet.
- Root · 6 generations backK981529 Titanium Intramedullary Nail, Titanium Locking ScrewSmith & Nephew, Inc. · 1998 · Recalled
- 5 generations backK040212 Trigen IntertanSmith & Nephew, Inc. · 2004 · Recalled
- 4 generations backK040656 Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc. · 2004
- 3 generations backK050226 Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc. · 2005
- 2 generations backK092748 Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc. · 2010 · Recalled
- 1 generation backK243364 TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc. · 2024
- This deviceK243608 TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981529 | Titanium Intramedullary Nail, Titanium Locking Screw | Smith & Nephew, Inc. | 1998 | 2 |
| −5 | K040212 | Trigen Intertan | Smith & Nephew, Inc. | 2004 | 6 |
| −4 | K040656 | Modification to Smith & Nephew Intramedullary Hip Screw | Smith & Nephew, Inc. | 2004 | — |
| −3 | K050226 | Asian Intramedullary Hip Screw Nails | Smith & Nephew, Inc. | 2005 | — |
| −2 | K092748 | Sureshot Tan Nails and Accessories | Smith & Nephew, Inc. | 2010 | 1 |
| −1 | K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | Smith & Nephew, Inc. | 2024 | — |
| 0 (this device) | K243608 | TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2023 | 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? (5)
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 |
|---|---|---|---|
| * | K983942 | Intramedullary Nail System, Locking Screw, Nail CapSummary page 6…3030 Product Code(s) JDS, HSB I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K983942 Stainless-Steel Stable Lock Nut & Washer JDS K111025 TRIGEN Low Profile Screw HSB K061019, K230761 TRIGEN META-NAIL Retrograde Fe… | 1998 |
| * | K111025 | Trigen Low Profile Bone ScrewSummary page 6…dicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K983942 Stainless-Steel Stable Lock Nut & Washer JDS K111025 TRIGEN Low Profile Screw HSB K061019, K230761 TRIGEN META-NAIL Retrograde Femoral Nail JDS K243364 TRIGEN META-TAN Trochanteric A… | 2011 |
| * | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial NailsSummary page 6…edicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K983942 Stainless-Steel Stable Lock Nut & Washer JDS K111025 TRIGEN Low Profile Screw HSB K061019, K230761 TRIGEN META-NAIL Retrograde Femoral Nail JDS K243364 TRIGEN META-TAN Trochanteric Antegrade Nail HSB Device Description… | 2006 |
| * | K230761 | TRIGEN META-NAIL Nail SystemSummary page 6…Predicate Trade Name (Primary Predicate is listed first) Product Code K983942 Stainless-Steel Stable Lock Nut & Washer JDS K111025 TRIGEN Low Profile Screw HSB K061019, K230761 TRIGEN META-NAIL Retrograde Femoral Nail JDS K243364 TRIGEN META-TAN Trochanteric Antegrade Nail HSB Device Description Summary 2… | 2023 |
| * | K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail Cleared while this submission was under review Summary page 6…rst) Product Code K983942 Stainless-Steel Stable Lock Nut & Washer JDS K111025 TRIGEN Low Profile Screw HSB K061019, K230761 TRIGEN META-NAIL Retrograde Femoral Nail JDS K243364 TRIGEN META-TAN Trochanteric Antegrade Nail HSB Device Description Summary 21 CFR 807.92(a)(4) The device in scope of this submi… | 2024 |
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 27 years and passes through 1 company; a new generation was cleared every 5.2 years on median.
- 9 of the 20 ancestors have a recall of any class.
- 17 other devices also cite its predicate K983942.
How does its category compare?
All JDS devicesJDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
The subject device can be used with the TRIGEN META-TAN Trochanteric Antegrade Nailing System, TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System, and the TRIGEN META-NAIL Retrograde Femoral Nail System therefore the indications for use for all three systems are applicable to the subject TRIGEN Stable Lock Nut & Washer. TRIGEN META-TAN Trochanteric Antegrade Nailing System The TRIGEN META-TAN Trochanteric Antegrade Nail is…
Read the full statement (270 words)
The subject device can be used with the TRIGEN META-TAN Trochanteric Antegrade Nailing System, TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System, and the TRIGEN META-NAIL Retrograde Femoral Nail System therefore the indications for use for all three systems are applicable to the subject TRIGEN Stable Lock Nut & Washer.
TRIGEN META-TAN Trochanteric Antegrade Nailing System
The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fixation of fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures.
In addition, TRIGEN META-TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; and intracapsular fractures.
TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; and nonunions. 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 (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures and intertrochanteric fractures.
TRIGEN META-NAIL Retrograde Femoral Nail System
The TRIGEN META-NAIL Retrograde Femoral Nail is indicated for fractures of the femur including stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic 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/K243608 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243608: TRIGEN Stable Lock Nut & Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243608
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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