510(k) · Cleared
ClearedIntramedullary Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weigao Orthopaedic Device Co., Ltd. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Oct 24, 2012 as substantially equivalent to K053261 (Orthofix Srl, 2005) after a 176-day review. Its family tree reaches back 1 generation to 2005. 3 later devices descend from it.
- Decided
- Oct 24, 2012
- Review
- 176 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053261 (2005). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK053261 Orthofix Titanium Nailing SystemsOrthofix Srl · 2005
- This deviceK121312 Intramedullary Nail SystemWeigao Orthopaedic Device Co., Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK132078 Metallic Intramedullary Nail SystemTianjin Walkman Biomaterial Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK151062 WASTON Metallic Intramedullary Nail SystemChangzhou Waston Medical Appliance Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK132428 IDEALJiangsu Ideal Medical Science & Technology Co., LT · 2013
Most influential descendants
Showing 3 of 3 · See all- K132078Metallic Intramedullary Nail SystemTianjin Walkman Biomaterial Co., Ltd. · 2014 · cites it directly1descendant
- K151062WASTON Metallic Intramedullary Nail SystemChangzhou Waston Medical Appliance Co., Ltd. · 2015 · 2 generations on0descendants
- K132428IDEALJiangsu Ideal Medical Science & Technology Co., LT · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053261 | Orthofix Titanium Nailing Systems | Orthofix Srl | 2005 | — |
| 0 (this device) | K121312 | Intramedullary Nail System | Weigao Orthopaedic Device Co., Ltd. | 2012 | — |
| +1 | K132078 | Metallic Intramedullary Nail System | Tianjin Walkman Biomaterial Co., Ltd. | 2014 | — |
| +2 | K151062 | WASTON Metallic Intramedullary Nail System | Changzhou Waston Medical Appliance Co., Ltd. | 2015 | — |
| +1 | K132428 | IDEAL | Jiangsu Ideal Medical Science & Technology Co., LT | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K053261 | Orthofix Titanium Nailing SystemsSummary page 2…3 Additional Information 11for K 121312 Exhibit #1 510(k) Summary Project #:M0012012 5. Predicate Device Identification 510(k) Number: K053261 Product Name: Orthofix Titanium Nailing System Submitter: R. Sheridan Consulting. LLC 6. Device Description Th… | 2005 |
What descends from it? (3)
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?
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. 2012, 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/K121312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121312: 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/K121312
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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