510(k) · Cleared
ClearedS2 Tibial Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Apr 25, 2002 after a 27-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Apr 25, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK021027 S2 Tibial NailHowmedica Osteonics Corp. · 2002
- Descendant · cites it directly · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- Descendant · 2 generations on · 3 of its ownK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
- Descendant · 3 generations on · 2 of its ownK181296 Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019
- Descendant · 2 generations on · 2 of its ownK141228 Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK230257 Arthrex Intramedullary NailsArthrex, Inc. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · cites it directly10descendants
- K161327Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017 · 2 generations on3descendants
- K181296Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019 · 3 generations on2descendants
- K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014 · 2 generations on2descendants
- K230257Arthrex Intramedullary NailsArthrex, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021027 | S2 Tibial Nail | Howmedica Osteonics Corp. | 2002 | — |
| +1 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| +2 | K161327 | Syntec Humeral Nail System | Syntec Scientific Corporation | 2017 | — |
| +3 | K181296 | Syntec Femoral Nail System | Syntec Scientific Corporation | 2019 | — |
| +2 | K141228 | Aos 6.5MM Captured, Fully Threaded Cancellous Screw | Advanced Orthopaedic Solutions, Inc. | 2014 | — |
| +3 | K230257 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | — | T2 Tibial Nail System Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail | 2014 | 10 |
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, K132945 (I.T.S. GmbH, 2014) has gone furthest, with 10 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 S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compression locked.
The S2 Tibial Nail System 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
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/K021027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021027: S2 Tibial Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021027
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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