510(k) · Cleared
ClearedFule Metallic Lockable Intramedullary Nail Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Fule Science & Technology Development Co., Ltd. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 17, 2026 as substantially equivalent to K200880 (Stryker GmbH, 2020) and 1 other predicate after a 264-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Jun 17, 2026
- Review
- 264 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K951740 (1995). 57 ancestors in all, the oldest K914371 (1992). No later device cites it as a predicate yet.
- Root · 7 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 6 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 5 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- 4 generations backK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- 3 generations backK111667 Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · Recalled
- 2 generations backK131365 T2 Tibial Nailing SystemStryker Trauma AG · 2013 · Recalled
- 1 generation backK200880 T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar…Stryker GmbH · 2020
- This deviceK253155 Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −6 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −5 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| −4 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
| −3 | K111667 | Synthes Suprapatellar Insertion Instruments | Synthes (Usa) | 2011 | 1 |
| −2 | K131365 | T2 Tibial Nailing System | Stryker Trauma AG | 2013 | 4 |
| −1 | K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail… | Stryker GmbH | 2020 | — |
| 0 (this device) | K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Summary page 6…ecific configurations and indications. Predicate 510(k) Predicate Device Product Code Status Number Primary K200880 T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar HSB Nail System, T2 Recon Na… | 2020 |
| * | K182783 | DePuy Synthes Trauma Orthopedic Nail ImplantsSummary page 6…Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail predicate (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System Additional K182783 DePuy Synthes Trauma Orthopedic Nail HRS / HSB as predicate Implants / Proximal Fem… | 2018 |
| † | K252730 | Fule Spinal Fixation System | 2025 |
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 31 years and passes through 6 companies; a new generation was cleared every 5.5 years on median.
- 26 of the 57 ancestors have a recall of any class.
- 2 other devices also cite its predicate K200880.
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. 2026, 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 Intramedullary Nail System of The Fule Metallic Lockable Intramedullary Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an open or closed technique and can be statically, dynamically and compressed locked. It is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: * Open and closed tibial…
Read the full statement (195 words)
The Intramedullary Nail System of The Fule Metallic Lockable Intramedullary Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an open or closed technique and can be statically, dynamically and compressed locked. It is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
* Open and closed tibial fractures
* Pseudoarthrosis and correction osteotomy
» Pathologic fractures, impending pathologic fractures, and tumor resections
* Nonunion and malunion.
The Fule Proximal Femoral Nail Systems (PFNA System and SISF System) of the Fule Metallic Lockable Intramedullary Nail are intended for the treatment of stable and unstable fractures of the proximal femur, including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof.
* Short nails (PFNA:170-240 mm / SISF: 180—240 mm):
* Pertrochanteric fractures
* Intertrochanteric fractures
» Basal neck fractures
» Combinations of these fracture types
* Long nails (PFNA:300—420 mm):
» 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
* 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/K253155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253155: Fule Metallic Lockable Intramedullary Nail Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253155
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026