510(k) · Cleared
Recalled · Class II · 2024TriMed Threaded Intramedullary Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
TriMed, Inc. · HWC Screw, Fixation, Bone
Cleared on Jan 18, 2024 as substantially equivalent to K211783 (TriMed, Inc., 2021) and 1 other predicate after a 28-day review. Its family tree reaches back 15 generations to 1996. It has been recalled 2 times.
- Decided
- Jan 18, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 15 generations to K962616 (1996). 150 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK192745 DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019
- 2 generations backK211783 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2021
- 1 generation backK230749 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2023
- This deviceK234040 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2024
Show all 15 generations
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 14 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 13 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 12 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 11 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 9 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 8 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 7 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 6 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 5 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 4 generations backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- 3 generations backK192745 DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019
- 2 generations backK211783 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2021
- 1 generation backK230749 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2023
- This deviceK234040 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −14 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −13 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −12 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −11 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −9 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −8 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −7 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −6 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −5 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| −4 | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated… | Synthes USA Products, LLC | 2017 | — |
| −3 | K192745 | DePuy Synthes Trauma Screws | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2019 | — |
| −2 | K211783 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2021 | — |
| −1 | K230749 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2023 | — |
| 0 (this device) | K234040 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 12 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 9 | 0 |
| 2000 | 11 | 0 |
| 2001 | 9 | 0 |
| 2002 | 10 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K211783 | TriMed Threaded Intramedullary Nail SystemSummary page 4…ber 888.3040 Product Code HWC | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211783 TriMed Threaded Intramedullary Nail System HWC K230749 TriMed Threaded Intramedullary Nail System HWC Device Description Summary… | 2021 |
| * | K230749 | TriMed Threaded Intramedullary Nail SystemSummary page 4…cate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211783 TriMed Threaded Intramedullary Nail System HWC K230749 TriMed Threaded Intramedullary Nail System HWC Device Description Summary 21 CFR 807.92(a)(4) TriMed Threaded Intramedullary (IM… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2024 | Class II | Z-1791-2024 | Process control | Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque. |
| Mar 19, 2024 | Class II | Z-1792-2024 | Process control | Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 26 of the 150 ancestors have a recall of any class.
- 1 other device also cites its predicate K211783.
How does its category compare?
All HWC devicesHWC Screw, 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 · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The TriMed Threaded IM Nail System is indicated for the treatment of select fractures and corrective osteotomies of short tubular bones.
Specific indications for TriMed Small Threaded IM Nails include:
1. Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies
2. Metacarpal fractures, non-unions, malunions and corrective osteotomies
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/K234040 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234040: TriMed Threaded Intramedullary Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234040
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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