510(k) · Cleared
ClearedT2 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 Jan 12, 2018 as substantially equivalent to K102992 (Howmedica Osteonics Corp., 2010) and 4 other predicates after a 120-day review. Its family tree reaches back 5 generations to 1997. 17 later devices descend from it.
- Decided
- Jan 12, 2018
- Review
- 120 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K970097 (1997). 25 ancestors in all, the oldest K871539 (1987). 17 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 4 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 3 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 2 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 1 generation backK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
- This deviceK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
- Descendant · cites it directly · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- Descendant · 2 generations on · 15 of its ownK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
- Descendant · 3 generations on · 9 of its ownK200869 Gamma3 SystemStryker Trauma GmbH · 2020
- Descendant · 3 generations on · 7 of its ownK203819 T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade…Stryker GmbH · 2021
- Descendant · 3 generations on · 4 of its ownK193308 T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · cites it directly16descendants
- K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH · 2019 · 2 generations on15descendants
- K200869Gamma3 SystemStryker Trauma GmbH · 2020 · 3 generations on9descendants
- K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH · 2021 · 3 generations on7descendants
- K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH · 2020 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −4 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −3 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −2 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −1 | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | 16 |
| 0 (this device) | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN… | Stryker Trauma GmbH | 2018 | — |
| +1 | K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System… | Stryker Trauma GmbH | 2018 | — |
| +2 | K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System… | Stryker Trauma GmbH | 2019 | — |
| +3 | K200869 | Gamma3 System | Stryker Trauma GmbH | 2020 | — |
| +3 | K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF… | Stryker GmbH | 2021 | — |
| +3 | K193308 | T2 Alpha Tibia Nailing System, IMN Screws System | Stryker Trauma GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K102992 | T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 DegreesSummary page 7…atory Class: Class II III. PREDICATE DEVICE T2 Alpha Femur Antegrade GT/PF Nailing System Primary predicate: T2 Recon Nail System (K102992) Additional predicate: T2 Greater Trochanter Nail (GTN) (K101438) Zimmer Natu… | 2010 |
| * | K101438 | T2 Greater Trochanter NailSummary page 7…Antegrade GT/PF Nailing System Primary predicate: T2 Recon Nail System (K102992) Additional predicate: T2 Greater Trochanter Nail (GTN) (K101438) Zimmer Natural Nail System Piriformis Fossa and Greater… | 2010 |
| * | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsSummary page 7…38) Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails (K083497) IMN Screws System Primary predicate: Titan Tibial Nail (K003018) IMN Instruments System Primary predicate:… | 2009 |
| * | K003018 | Titan Tibial NailSummary page 7…and Greater Trochanter Antegrade Femoral Nails (K083497) IMN Screws System Primary predicate: Titan Tibial Nail (K003018) IMN Instruments System Primary predicate: Gamma3 and T2 Recon Target Devices (K123401) Reference device:… | 2000 |
| * | K123401 | GAMMA3 and T2 Recon Targeting DevicesSummary page 7…System Primary predicate: Titan Tibial Nail (K003018) IMN Instruments System Primary predicate: Gamma3 and T2 Recon Target Devices (K123401) Reference device: T2 Recon Nail System (K102992) IV. DEVICE DESCRIPTION This Traditional 510(k) submission… | 2013 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws… | 2018 | 16 |
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.
- 16 of the 25 ancestors have a recall of any class.
- Of its descendants, K180436 (Stryker Trauma GmbH, 2018) has gone furthest, with 16 descendants of its own.
- 4 other devices also cite its predicate K102992.
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 these internal fixation devices include: - Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comnunuted 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…
Read the full statement (128 words)
The indications for use of these internal fixation devices include:
- Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comnunuted 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
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.
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/K172774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172774: 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/K172774
Report an extraction error
Are you the manufacturer?
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