510(k) · Cleared
ClearedT2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Aug 20, 2025 as substantially equivalent to K032523 (Howmedica Osteonics Corp., 2003) and 2 other predicates after a 106-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Aug 20, 2025
- Review
- 106 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K970097 (1997). 69 ancestors in all, the oldest K871539 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 6 generations between
- 3 generations backK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
- 2 generations backK193308 T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH · 2020
- 1 generation backK213328 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing…Stryker GmbH · 2022 · Recalled
- This deviceK251400 T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH · 2025
Show all 10 generations
- Root · 10 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 9 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 8 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 7 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 6 generations backK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
- 5 generations backK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
- 4 generations backK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- 3 generations backK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
- 2 generations backK193308 T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH · 2020
- 1 generation backK213328 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing…Stryker GmbH · 2022 · Recalled
- This deviceK251400 T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −9 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −8 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −7 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −6 | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | 16 |
| −5 | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN… | Stryker Trauma GmbH | 2018 | — |
| −4 | K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System… | Stryker Trauma GmbH | 2018 | — |
| −3 | K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System… | Stryker Trauma GmbH | 2019 | — |
| −2 | K193308 | T2 Alpha Tibia Nailing System, IMN Screws System | Stryker Trauma GmbH | 2020 | — |
| −1 | K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System | Stryker GmbH | 2022 | 1 |
| 0 (this device) | K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K032523 | T2 Nailing SystemSummary page 5…[email protected] Date Prepared: May 06, 2025 Predicate Device: Primary Predicate: T2 Nailing System (K032523) Additional Predicate: Tornier Humeral Nail and Tornier Long… | 2003 |
| * | K230352 | Tornier Humeral Nail and Tornier Long Humeral NailSummary page 5…ailing System (K032523) Additional Predicate: Tornier Humeral Nail and Tornier Long Humeral Nail (K230352) IMN Screws System (K213328) Device Description: The T2 Alpha Humerus Nail… | 2023 |
| * | K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemSummary page 5…ional Predicate: Tornier Humeral Nail and Tornier Long Humeral Nail (K230352) IMN Screws System (K213328) Device Description: The T2 Alpha Humerus Nailing System is an intramedullary… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 34 of the 69 ancestors have a recall of any class.
- 2 other devices also cite its predicate K032523.
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. 2025, 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 Alpha Humerus Nailing System is indicated for the treatment of humerus fractures. Fractures can include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization. The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures…
Read the full statement (120 words)
The T2 Alpha Humerus Nailing System is indicated for the treatment of humerus fractures. Fractures can include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures.
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions, and non-unions of the humerus. The nails are inserted using an open or closed technique and can be static, dynamic, or compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but are not limited to, fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.
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/K251400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251400: T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251400
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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