510(k) · Cleared
ClearedSyntec Femoral Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntec Scientific Corporation · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Apr 11, 2019 as substantially equivalent to K040462 (Smith & Nephew, Inc., 2004) and 2 other predicates after a 330-day review. Its family tree reaches back 7 generations to 2000. 2 later devices descend from it.
- Decided
- Apr 11, 2019
- Review
- 330 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K000684 (2000). 74 ancestors in all, the oldest K890939 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 6 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 5 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 4 generations backK063460 Acumed Congruent Bone Plate SystemAcumed, LLC · 2006
- 3 generations backK080184 Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2008 · Recalled
- 2 generations backK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- 1 generation backK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
- This deviceK181296 Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019
- Descendant · cites it directly · 0 of its ownK202935 Syntec Femoral Nail Extended SystemSyntec Scientific Corporation · 2020
- Descendant · cites it directly · 0 of its ownK191617 Syntec Tibial Nail SystemSyntec Scientific Corporation · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −6 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −5 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −4 | K063460 | Acumed Congruent Bone Plate System | Acumed, LLC | 2006 | — |
| −3 | K080184 | Distal Humeral Plates with Angular Stability | I.T.S. Implantat-Technologie-Systeme GmbH | 2008 | 1 |
| −2 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| −1 | K161327 | Syntec Humeral Nail System | Syntec Scientific Corporation | 2017 | — |
| 0 (this device) | K181296 | Syntec Femoral Nail System | Syntec Scientific Corporation | 2019 | — |
| +1 | K202935 | Syntec Femoral Nail Extended System | Syntec Scientific Corporation | 2020 | — |
| +1 | K191617 | Syntec Tibial Nail System | Syntec Scientific Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 9 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 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 |
|---|---|---|---|
| * | K040462 | Trigen Trochanteric Antegrade NailSummary page 4…gulation number: 21CFR888.3020 Class: Class II Predicate devices: Trigen Trochanteric Antegrade Nail (K040462) Syntec Humeral Nail System (K161327) Syntec-Taic… | 2004 |
| * | K161327 | Syntec Humeral Nail SystemSummary page 4…Class II Predicate devices: Trigen Trochanteric Antegrade Nail (K040462) Syntec Humeral Nail System (K161327) Syntec-Taichung Non-sterile Interlocking Nail System… | 2017 |
| * | K984543 | Syntec-Taichung Non-Sterile Interlocking Nail System, Model:Humerus:256-000/280…Summary page 4…yntec Humeral Nail System (K161327) Syntec-Taichung Non-sterile Interlocking Nail System (K984543) Prior Submission: None Syntec, Taipei-Taiwan… | 1999 |
What descends from it? (2)
2 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)
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 19 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 32 of the 74 ancestors have a recall of any class.
- Of its descendants, K202935 (Syntec Scientific Corporation, 2020) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K040462.
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. 2019, 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 Syntec Femoral Nail System is indicated for long bone fracture fixation which may include the following:
Fractures, and tumor resections; Fractures proximal to a total knee arthroplasty; Supracondylar and ipsilateral fractures;
Delayed union fractures; Open and closed femur shaft fractures; Combined inter and subrochanteric fractures; High
subtrochanteric fractures; Pseudoarthrosis and correction osteotomy; Pathological fractures, impending pathologic and
tumor resections; Pertrochanteric fractures; and Nonunions and malunions.
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/K181296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181296: Syntec Femoral Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181296
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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