510(k) · Cleared
ClearedOrthofix Titanium Nailing Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix Srl · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 12, 2005 after a 20-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Dec 12, 2005
- Review
- 20 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK053261 Orthofix Titanium Nailing SystemsOrthofix Srl · 2005
- Descendant · cites it directly · 3 of its ownK121312 Intramedullary Nail SystemWeigao Orthopaedic Device Co., Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK161466 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemOrthofix Srl · 2017
- Descendant · 2 generations on · 1 of its ownK132078 Metallic Intramedullary Nail SystemTianjin Walkman Biomaterial Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK173458 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemOrthofix Srl · 2017
- Descendant · 3 generations on · 0 of its ownK151062 WASTON Metallic Intramedullary Nail SystemChangzhou Waston Medical Appliance Co., Ltd. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K121312Intramedullary Nail SystemWeigao Orthopaedic Device Co., Ltd. · 2012 · cites it directly3descendants
- K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemOrthofix Srl · 2017 · cites it directly1descendant
- K132078Metallic Intramedullary Nail SystemTianjin Walkman Biomaterial Co., Ltd. · 2014 · 2 generations on1descendant
- K173458ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemOrthofix Srl · 2017 · 2 generations on0descendants
- K151062WASTON Metallic Intramedullary Nail SystemChangzhou Waston Medical Appliance Co., Ltd. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053261 | Orthofix Titanium Nailing Systems | Orthofix Srl | 2005 | — |
| +1 | K121312 | Intramedullary Nail System | Weigao Orthopaedic Device Co., Ltd. | 2012 | — |
| +1 | K161466 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System | Orthofix Srl | 2017 | — |
| +2 | K132078 | Metallic Intramedullary Nail System | Tianjin Walkman Biomaterial Co., Ltd. | 2014 | — |
| +2 | K173458 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System | Orthofix Srl | 2017 | — |
| +3 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (6)
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?
- Of its descendants, K121312 (Weigao Orthopaedic Device Co., Ltd., 2012) has gone furthest, with 3 descendants of its own.
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.
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?
Each nail within the Orthofix Titanium Nailing System is intended for insertion into the medullary canal of a specific long bone - humerus, femur and tibia - for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: traumatic fractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053261 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053261: Orthofix Titanium Nailing Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053261
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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