510(k) · Cleared
Recalled · Class II · 2017Synthes (Usa) Trochanteric Fixation Nail (TFN) System
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 Sep 12, 2001 after a 90-day review. The FDA summary names its predicate without a number. 11 later devices descend from it. It has been recalled 7 times.
- Decided
- Sep 12, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 7
- Predicates
- 0
11 later devices descend from it, 7 citing it directly.
- This deviceK011857 Synthes (Usa) Trochanteric Fixation Nail (TFN) SystemSynthes (Usa) · 2001
- Descendant · cites it directly · 3 of its ownK120083 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 · cites it directly · 2 of its ownK151010 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK153536 Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK253155 Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K120083Set Screw for TI Trochanteric Fixation Nail (TFN)Synthes USA · 2012 · cites it directly3descendants
- K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes · 2018 · cites it directly2descendants
- K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2015 · cites it directly2descendants
- K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd. · 2016 · 2 generations on1descendant
- K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011857 | Synthes (Usa) Trochanteric Fixation Nail (TFN) System | Synthes (Usa) | 2001 | — |
| +1 | K120083 | Set Screw for TI Trochanteric Fixation Nail (TFN) | Synthes USA | 2012 | — |
| +1 | K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | DePuy Synthes | 2018 | — |
| +1 | K151010 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2015 | 1 |
| +2 | K153536 | Piccolo Composite® Nailing System | CarboFix Orthopedics, Ltd. | 2016 | 1 |
| +2 | K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | — | Howmedica Gamma® Nail System, including modifications for the Long Length and Short… Named without a submission number |
What descends from it? (11)
See all 117 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120083 | Set Screw for TI Trochanteric Fixation Nail (TFN) | 2012 | 3 |
| K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | 2018 | 2 |
| K151010 | Piccolo Composite Nailing System | 2015 | 2 |
| K233150 | NET BRAND Osteosynthesis Nailing System | 2024 | 0 |
| K230456 | SGM Femoral Nail System | 2023 | 0 |
| K203811 | GPC Intraheal Intramedullary Nailing System | 2022 | 0 |
| K093089 | Magnum Nail | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2017 | Class II | Z-0604-2018 | Employee error | The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot. |
| Nov 2, 2015 | Class II | Z-0375-2016 | Process control | TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or… |
| Oct 29, 2014 | Class II | Z-0219-2015 | Employee error | The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction… |
| Jul 31, 2013 | Class II | Z-0387-2014 | Process control | The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck. |
| Jul 30, 2013 | Class II | Z-0452-2014 | Nonconforming Material/Component | Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail. |
| Jul 30, 2013 | Class II | Z-0474-2014 | Employee error | Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging. |
| Nov 2, 2012 | Class II | Z-2058-2013 | Packaging change control | Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K120083 (Synthes USA, 2012) has gone furthest, with 3 descendants of its own.
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.
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?
Synthes Trochanteric Fixation Nail (TFN) System 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 TFN 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011857 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011857: Synthes (Usa) Trochanteric Fixation Nail (TFN) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011857
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026