510(k) · Cleared
ClearedOrthofix Tibial Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on May 8, 1996 as substantially equivalent to K912420 (Scientific Research, 1991) and 1 other predicate after a 55-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- May 8, 1996
- Review
- 55 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912420 (1991). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K973944Orthofix Femoral Nailing SytemOrthofix Srl · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912420 | Orthofix Unreamed Tibial Nail System | Scientific Research | 1991 | — |
| 0 (this device) | K961027 | Orthofix Tibial Nailing System | Orthofix, Inc. | 1996 | — |
| +1 | K973944 | Orthofix Femoral Nailing Sytem | Orthofix Srl | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K912420 | Orthofix Unreamed Tibial Nail SystemSummary page 3…d or non-unions; stabilization after corrective osteotomy; and bone transport. 000276 Substantial Equivalence The Orthofix Unreamed Tibial Nail System, K912420, originally received 510(k) clearance on September 23, 1991. Orthofix will now offer a greater selection of tibial nails. The nai… | 1991 |
| * | K914453 | Universal Tibial Nail and Unreamed Tibial NailSummary page 3…ng System with the additions cited remains substantially equivalent to itself and other legally marketed predicate devices, such as the Synthes’ Universal & UTN Systems (K914453) and Richards’ Russell Taylor System. 000<77 | 1992 |
| * | — | Richards’ Russell Taylor System Named without a submission number |
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 |
|---|---|---|---|
| K973944 | Orthofix Femoral Nailing Sytem | 1997 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K973944 (Orthofix Srl, 1997) has gone furthest, with 0 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?
The system is indicated for fixation of tie following conditions where the area requiring fixation is distal to the tibial tuberosity and at least 55 mm proximal to the distal articular surface: acute traumatic fractures; pathological fractures; delayed or non-unions; stabilization after corrective osteotomy; and bone transport.
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/K961027 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961027: Orthofix Tibial Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961027
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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