510(k) · Cleared
ClearedSyntec Tibial 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 Sep 3, 2019 as substantially equivalent to K984543 (Syntec Scientific Corp., 1999) and 2 other predicates after a 77-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Sep 3, 2019
- Review
- 77 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K000684 (2000). 75 ancestors in all, the oldest K890939 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 7 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 6 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 5 generations backK063460 Acumed Congruent Bone Plate SystemAcumed, LLC · 2006
- 4 generations backK080184 Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2008 · Recalled
- 3 generations backK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- 2 generations backK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
- 1 generation backK181296 Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019
- This deviceK191617 Syntec Tibial Nail SystemSyntec Scientific Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −7 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −6 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −5 | K063460 | Acumed Congruent Bone Plate System | Acumed, LLC | 2006 | — |
| −4 | K080184 | Distal Humeral Plates with Angular Stability | I.T.S. Implantat-Technologie-Systeme GmbH | 2008 | 1 |
| −3 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| −2 | K161327 | Syntec Humeral Nail System | Syntec Scientific Corporation | 2017 | — |
| −1 | K181296 | Syntec Femoral Nail System | Syntec Scientific Corporation | 2019 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K984543 | Syntec-Taichung Non-Sterile Interlocking Nail System, Model:Humerus:256-000/280…Summary page 4…3020 Class: Class II Primary Predicate: Syntec-Taichung Non-Sterile Interlocking Nail System (K984543) Additional Predicates: Syntec Femoral Nail System (K181296) Synthes (USA) Tibial Na… | 1999 |
| * | K181296 | Syntec Femoral Nail SystemSummary page 4…Syntec-Taichung Non-Sterile Interlocking Nail System (K984543) Additional Predicates: Syntec Femoral Nail System (K181296) Synthes (USA) Tibial Nail System Ex (K040762)… | 2019 |
| * | K040762 | Synthes (Usa) Tibial Nail System EXSummary page 4…(K984543) Additional Predicates: Syntec Femoral Nail System (K181296) Synthes (USA) Tibial Nail System Ex (K040762) K191617 Page 2/4 SYNTEC SCIENTIF… | 2004 |
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 19 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 32 of the 75 ancestors have a recall of any class.
- 2 other devices also cite its predicate K984543.
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 Tibial Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; certain pre- and post-isthmic fractures; open and closed tibial shaft fractures; and tibial malunions and non-unions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191617: Syntec Tibial 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/K191617
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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