510(k) · Cleared
Recalled · Class II · 2013Trigen Low Profile Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 1, 2011 as substantially equivalent to K981529 (Smith & Nephew, Inc., 1998) and 1 other predicate after a 79-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it. It has been recalled once.
- Decided
- Jul 1, 2011
- Review
- 79 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981529 (1998). 2 ancestors in all. 5 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK981529 Titanium Intramedullary Nail, Titanium Locking ScrewSmith & Nephew, Inc. · 1998 · Recalled
- This deviceK111025 Trigen Low Profile Bone ScrewSmith & Nephew, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK243608 TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK210980 Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK161264 TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK123948 China Nails and AccessoriesSmith & Nephew, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK122170 Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc. · 2025 · cites it directly0descendants
- K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc. · 2022 · cites it directly0descendants
- K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. · 2016 · cites it directly0descendants
- K123948China Nails and AccessoriesSmith & Nephew, Inc. · 2013 · cites it directly0descendants
- K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981529 | Titanium Intramedullary Nail, Titanium Locking Screw | Smith & Nephew, Inc. | 1998 | 2 |
| 0 (this device) | K111025 | Trigen Low Profile Bone Screw | Smith & Nephew, Inc. | 2011 | — |
| +1 | K243608 | TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. | 2025 | — |
| +1 | K210980 | Smith & Nephew Intramedullary Nail Systems | Smith & Nephew, Inc. | 2022 | 4 |
| +1 | K161264 | TRIGEN Low Profile Bone Screws | Smith & Nephew, Inc. | 2016 | — |
| +1 | K123948 | China Nails and Accessories | Smith & Nephew, Inc. | 2013 | — |
| +1 | K122170 | Smith & Nephew, Inc. Intramedullary Nail System Instrumentation | Smith & Nephew, Inc. | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 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 |
|---|---|---|---|
| * | K981529 | Titanium Intramedullary Nail, Titanium Locking ScrewSummary page 1…Bone Screw. The subject device is a modification of the bone screws included in the ITRIGEN 0I Titanium Intramedullary IMN Nail System cleared by premarket notification K981529. The TRIGEN 0 Low Profile Bone Screw ismanufactured from titanium alloy (T-6A1-41V), contains an internal hex drive feature in th… | 1998 |
| * | K983942 | Intramedullary Nail System, Locking Screw, Nail CapSummary page 2…tification K(981529. The indications and intended use of the subject device isalso similar to the bone screws included in the (Russell-Tayloro) IMNail System cleared via K983942- Design features of the TRIGEN 0 Low Profile Bone Screw have been compared to the previously cleared devices inTable 2 below. ==… | 1998 |
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 6, 2013 | Class II | Z-1132-2013 | Process control | One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The TRIGEN 0 Low Profile Bone Screw can be used with several types of nails in Smith & Nephew's (TRIGENI Titanium Nail System. The TRIGEN 0 Low Profile Bone Screw therefore has the following indications: 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…
Read the full statement (395 words)
The TRIGEN 0 Low Profile Bone Screw can be used with several types of nails in Smith & Nephew's (TRIGENI Titanium Nail System. The TRIGEN 0 Low Profile Bone Screw therefore has the following indications:
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 (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegradle Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures.
In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail; Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (pen-prosthetic fractures).
The TRIGEN 0 InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; intracapsular fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathotdgic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening.
SURESHOT* TAN Nails are indicated for fractures of the femur including 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; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur.
In addition, SURESHOT 0TAN 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; ipsilateral femoral shaft/neck fractures; and intracapsutar fractures.
The IRIGEN 0 Low Profile Bone Screw is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111025: Trigen Low Profile Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111025
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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