510(k) · Cleared
ClearedT2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Aug 8, 2011 as substantially equivalent to K014220 (Howmedica Osteonics Corp., 2002) and 3 other predicates after a 20-day review. Its family tree reaches back 1 generation to 2001. 10 later devices descend from it.
- Decided
- Aug 8, 2011
- Review
- 20 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K010801 (2001). 4 ancestors in all. 10 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK010801 T2 Femoral NailHowmedica Osteonics Corp. · 2001 · Recalled
- This deviceK112059 T2 Femoral Nail Model 1825-Xxxxcp, 1828-XxxxcpStryker · 2011
- Descendant · cites it directly · 2 of its ownK171108 AUTOBAHN Nailing SystemGlobus Medical, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK150655 OIC Intramedullary Nail SystemOrthopaedic Implant Company · 2015
- Descendant · 2 generations on · 1 of its ownK220659 AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK181184 OIC Intramedullary Nail SystemThe Orthopaedic Implant Company · 2018
- Descendant · cites it directly · 1 of its ownK141103 Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K171108AUTOBAHN Nailing SystemGlobus Medical, Inc. · 2017 · cites it directly2descendants
- K150655OIC Intramedullary Nail SystemOrthopaedic Implant Company · 2015 · cites it directly2descendants
- K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc. · 2022 · 2 generations on1descendant
- K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company · 2018 · 2 generations on1descendant
- K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A · 2014 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010801 | T2 Femoral Nail | Howmedica Osteonics Corp. | 2001 | 2 |
| 0 (this device) | K112059 | T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp | Stryker | 2011 | — |
| +1 | K171108 | AUTOBAHN Nailing System | Globus Medical, Inc. | 2017 | — |
| +1 | K150655 | OIC Intramedullary Nail System | Orthopaedic Implant Company | 2015 | — |
| +2 | K220659 | AUTOBAHN (R) EVO Femoral Nails | Globus Medical, Inc. | 2022 | — |
| +2 | K181184 | OIC Intramedullary Nail System | The Orthopaedic Implant Company | 2018 | — |
| +1 | K141103 | Intramedullary Nail and Screws-Neonail | Neoortho Produtos Ortopedicos S/A | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K014220 | T2 Femoral Nail SystemSummary page 1…te Prepared: qiiac is Claimed: Legally Marketed Device to Which Susata K014220, K01 0801 T2 Femoral Nail System: K08 1152, K021744, Description:beslgtybwdtacom… | 2002 |
| * | K010801 | T2 Femoral NailSummary page 1…ed: qiiac is Claimed: Legally Marketed Device to Which Susata K014220, K01 0801 T2 Femoral Nail System: K08 1152, K021744, Description:beslgtybwdtacom… | 2001 |
| * | K081152 | T2 Femoral NailSummary page 1…qiiac is Claimed: Legally Marketed Device to Which Susata K014220, K01 0801 T2 Femoral Nail System: K08 1152, K021744, Description:beslgtybwdtacom aeth… | 2008 |
| * | K021744 | T2 Femoral NailSummary page 1…qiiac is Claimed: Legally Marketed Device to Which Susata K014220, K01 0801 T2 Femoral Nail System: K08 1152, K021744, Description:beslgtybwdtacom aeth… | 2002 |
What descends from it? (10)
5 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. 2011, 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?
The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following:
* Open and closed femoral fractures
* Pseudoarthrosis and correction osteotomy
* Pathologic fractures, impending pathologic fractures, and tumor resections
* Supracondylar fractures, including those with intra-articular extension
* Ipsilateral femur fractures
* Fractures proximal to a total knee arthroplasty
* Fractures distal to hip joint
* Nonunions and malunions
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/K112059 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112059: T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112059
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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