510(k) · Cleared
ClearedTRIGEN Low Profile Bone Screws
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 Nov 23, 2016 as substantially equivalent to K111025 (Smith & Nephew, Inc., 2011) after a 202-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Nov 23, 2016
- Review
- 202 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981529 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981529 | Titanium Intramedullary Nail, Titanium Locking Screw | Smith & Nephew, Inc. | 1998 | 2 |
| −1 | K111025 | Trigen Low Profile Bone Screw | Smith & Nephew, Inc. | 2011 | 1 |
| 0 (this device) | K161264 | TRIGEN Low Profile Bone Screws | Smith & Nephew, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (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 |
|---|---|---|---|
| * | K111025 | Trigen Low Profile Bone ScrewSummary page 5…ket notification demonstrated that the proposed TRIGEN™ Low Profile Bone Screws are substantially equivalent to the legally marketed primary predicate devices cleared in K111025 with regard to intended use, indications for use, and performance characteristics. The subject TRIGEN™ Low Profile Bone Screws f… | 2011 |
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 18 years and passes through 1 company; a new generation was cleared every 13.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 4 other devices also cite its predicate K111025.
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. 2016, 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™ Low Profile Bone Screw can be used with several types of nails in Smith & Nephew’s (TRIGEN™) Titanium Nail System. The TRIGEN™ 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 (389 words)
The TRIGEN™ Low Profile Bone Screw can be used with several types of nails in Smith & Nephew’s (TRIGEN™) Titanium Nail System. The TRIGEN™ 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 Antegrade 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 (peri-prosthetic fractures).
The TRIGEN™ 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 pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening.
META-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, 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; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.
The TRIGEN™ Low Profile Bone Screw is intended for single use only.
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/K161264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161264: TRIGEN Low Profile Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161264
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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