510(k) · Cleared
ClearedSet Screw for TI Trochanteric Fixation Nail (TFN)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 8, 2012 as substantially equivalent to K092646 (Synthes (Usa), 2009) and 2 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1998. 3 later devices descend from it.
- Decided
- Feb 8, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K981529 (1998). 8 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK981529 Titanium Intramedullary Nail, Titanium Locking ScrewSmith & Nephew, Inc. · 1998 · Recalled
- 1 generation backK040212 Trigen IntertanSmith & Nephew, Inc. · 2004 · Recalled
- This deviceK120083 Set Screw for TI Trochanteric Fixation Nail (TFN)Synthes USA · 2012
- Descendant · cites it directly · 2 of its ownK182783 DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes · 2018
- Descendant · 2 generations on · 0 of its ownK253155 Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK201830 ANSER Clavicle PinBAAT Medical Products B.V. · 2020
Most influential descendants
Showing 3 of 3 · See all- K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes · 2018 · cites it directly2descendants
- K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd. · 2026 · 2 generations on0descendants
- K201830ANSER Clavicle PinBAAT Medical Products B.V. · 2020 · 2 generations on0descendants
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 | K040212 | Trigen Intertan | Smith & Nephew, Inc. | 2004 | 6 |
| 0 (this device) | K120083 | Set Screw for TI Trochanteric Fixation Nail (TFN) | Synthes USA | 2012 | — |
| +1 | K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | DePuy Synthes | 2018 | — |
| +2 | K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | 2026 | — |
| +2 | K201830 | ANSER Clavicle Pin | BAAT Medical Products B.V. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K092646 | Synthes (Usa) Trochanteric Fixation Nail (TFN) ScrewSummary page 1…and Accessories, Class 11, §888.3020 - (Intramedullary fixation rod.) Predicate Devices: Synthes Trochanteric Fixation Nail (TFN) Screw K092646 Synthes Trochanteric Fixation Nail (TEN) KOI 1857 Smith & Nephew, Inc. TriG… | 2009 |
| * | K011857 | Synthes (Usa) Trochanteric Fixation Nail (TFN) System | 2001 |
| * | K040212 | Trigen IntertanSummary page 1…on Nail (TFN) Screw K092646 Synthes Trochanteric Fixation Nail (TEN) KOI 1857 Smith & Nephew, Inc. TriGen lnterTAN0 K040212 Device Description: The Set Screw for Ti Trochanteric Fixation Nail (TFN) is an additional offer… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | 2018 | 2 |
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 14 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K182783 (DePuy Synthes, 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K092646.
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. 2012, 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 Set Screw for Ti Trochanteric Fixation Nail (TFN) is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures and combinations thereof The long TEN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120083: Set Screw for TI Trochanteric Fixation Nail (TFN).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120083
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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