510(k) · Cleared
ClearedT2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Trauma GmbH · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 6, 2018 as substantially equivalent to K003018 (Howmedica Osteonics Corp., 2000) and 3 other predicates after a 106-day review. Its family tree reaches back 6 generations to 1997. 16 later devices descend from it.
- Decided
- Jun 6, 2018
- Review
- 106 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K970097 (1997). 33 ancestors in all, the oldest K871539 (1987). 16 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 5 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 4 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 3 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 2 generations backK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
- 1 generation backK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
- This deviceK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- Descendant · cites it directly · 15 of its ownK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
- Descendant · 2 generations on · 9 of its ownK200869 Gamma3 SystemStryker Trauma GmbH · 2020
- Descendant · 2 generations on · 7 of its ownK203819 T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade…Stryker GmbH · 2021
- Descendant · 2 generations on · 4 of its ownK193308 T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH · 2020
- Descendant · 3 generations on · 3 of its ownK213328 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing…Stryker GmbH · 2022 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH · 2019 · cites it directly15descendants
- K200869Gamma3 SystemStryker Trauma GmbH · 2020 · 2 generations on9descendants
- K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH · 2021 · 2 generations on7descendants
- K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH · 2020 · 2 generations on4descendants
- K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH · 2022 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −5 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −4 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −3 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −2 | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | 16 |
| −1 | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN… | Stryker Trauma GmbH | 2018 | — |
| 0 (this device) | K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System… | Stryker Trauma GmbH | 2018 | — |
| +1 | K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System… | Stryker Trauma GmbH | 2019 | — |
| +2 | K200869 | Gamma3 System | Stryker Trauma GmbH | 2020 | — |
| +2 | K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF… | Stryker GmbH | 2021 | — |
| +2 | K193308 | T2 Alpha Tibia Nailing System, IMN Screws System | Stryker Trauma GmbH | 2020 | — |
| +3 | K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System | Stryker GmbH | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K003018 | Titan Tibial NailSummary page 8…ccessories) Regulatory Class: Class II III. PREDICATE DEVICE T2 Alpha Tibia Nailing System Primary predicate device: Titan Tibial Nail (K003018) Additional predicate devices: Zimmer Natural Nail System Tibial Nail (K082770) Synth… | 2000 |
| * | K082770 | Zimmer Natural Nail System Tibial NailSummary page 8…Alpha Tibia Nailing System Primary predicate device: Titan Tibial Nail (K003018) Additional predicate devices: Zimmer Natural Nail System Tibial Nail (K082770) Synthes (USA) Tibial Nail System EX (K040762) IMN Screws System Predicate device:… | 2008 |
| * | K040762 | Synthes (Usa) Tibial Nail System EXSummary page 8…(K003018) Additional predicate devices: Zimmer Natural Nail System Tibial Nail (K082770) Synthes (USA) Tibial Nail System EX (K040762) IMN Screws System Predicate device: IMN Screws System (K172774) Reference device: Titan… | 2004 |
| * | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemSummary page 8…(K082770) Synthes (USA) Tibial Nail System EX (K040762) IMN Screws System Predicate device: IMN Screws System (K172774) Reference device: Titan Tibial Nail (K003018)… | 2018 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws… | 2019 | 15 |
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 21 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 19 of the 33 ancestors have a recall of any class.
- Of its descendants, K191271 (Stryker Trauma GmbH, 2019) has gone furthest, with 15 descendants of its own.
- 12 other devices also cite its predicate K003018.
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. 2018, 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 indications for use of this internal fixation device include: • Open and closed tibial fractures • Pseudoarthrosis and correction osteotomy • Pathologic fractures, impending pathologic fractures, and tumor resections • Fractures involving osteopenic and osteoporotic bone • Nonunion and malunion The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing…
Read the full statement (198 words)
The indications for use of this internal fixation device include:
• Open and closed tibial fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Fractures involving osteopenic and osteoporotic bone
• Nonunion and malunion
The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
The IMN Instruments System is intended to enable the implantation and extraction of intramedullary nail and screw.
The indications for use of these internal fixation devices include:
• Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
• Femoral fixation required as a result of pathological disease
• Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Ipsilateral femur fractures
• Fractures proximal to a total knee arthroplasty
• Nonunions and malunions
• Fractures involving osteopenic and osteoporotic bone
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180436: T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180436
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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