510(k) · Cleared
ClearedMetallic Intramedullary Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianjin Walkman Biomaterial Co., Ltd. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 19, 2014 as substantially equivalent to K121312 (Weigao Orthopaedic Device Co., Ltd., 2012) after a 257-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Mar 19, 2014
- Review
- 257 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K053261 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK053261 Orthofix Titanium Nailing SystemsOrthofix Srl · 2005
- 1 generation backK121312 Intramedullary Nail SystemWeigao Orthopaedic Device Co., Ltd. · 2012
- This deviceK132078 Metallic Intramedullary Nail SystemTianjin Walkman Biomaterial Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK151062 WASTON Metallic Intramedullary Nail SystemChangzhou Waston Medical Appliance Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K151062WASTON Metallic Intramedullary Nail SystemChangzhou Waston Medical Appliance Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K053261 | Orthofix Titanium Nailing Systems | Orthofix Srl | 2005 | — |
| −1 | K121312 | Intramedullary Nail System | Weigao Orthopaedic Device Co., Ltd. | 2012 | — |
| 0 (this device) | K132078 | Metallic Intramedullary Nail System | Tianjin Walkman Biomaterial Co., Ltd. | 2014 | — |
| +1 | K151062 | WASTON Metallic Intramedullary Nail System | Changzhou Waston Medical Appliance Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K121312 | Intramedullary Nail SystemSummary page 4…The proposed device, Metallic Intramedullary Nail System, is determined to be Substantially Equivalent (SE) to the predicate device, lntramcdullarv Nail System (K 12 1312), in respect of safety and effectiveness.… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151062 | WASTON Metallic Intramedullary Nail System | 2015 | 0 |
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 9 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K151062 (Changzhou Waston Medical Appliance Co., Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K121312.
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. 2014, 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?
Simple, compound first- and second-degree tibial shaft fractures;
Pseudarthrosis and delayed union.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132078: Metallic Intramedullary 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/K132078
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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