510(k) · Cleared
ClearedT2 Alpha Femur Retrograde 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 13, 2025 as substantially equivalent to K203819 (Stryker GmbH, 2021) and 3 other predicates after a 204-day review. Its family tree reaches back 20 generations to 1996. 2 later devices descend from it.
- Decided
- Aug 13, 2025
- Review
- 204 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 20 generations to K954385 (1996). 331 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 20 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 16 generations between
- 3 generations backK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- 2 generations backK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- 1 generation backK231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea…Stryker GmbH · 2023
- This deviceK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
- Descendant · cites it directly · 1 of its ownK253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur…Stryker GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK261481 Pangea Femur Reconstruction SystemStryker GmbH · 2026
Show all 20 generations
- Root · 20 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 19 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 18 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 17 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 16 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 15 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 14 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 13 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 12 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 11 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 10 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 9 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 8 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 7 generations backK153379 AxSOS 3TiStryker GmbH · 2016
- 6 generations backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- 5 generations backK172350 AxSOS 3 TiStryker GmbH · 2017
- 4 generations backK181091 AxSOS 3 TiStryker GmbH · 2018
- 3 generations backK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- 2 generations backK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- 1 generation backK231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea…Stryker GmbH · 2023
- This deviceK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −19 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −18 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −17 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −16 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −15 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −14 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −13 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −12 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −11 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −10 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −9 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −8 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −7 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| −6 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| −5 | K172350 | AxSOS 3 Ti | Stryker GmbH | 2017 | — |
| −4 | K181091 | AxSOS 3 Ti | Stryker GmbH | 2018 | — |
| −3 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| −2 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker… | Stryker GmbH | 2023 | — |
| −1 | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia… | Stryker GmbH | 2023 | — |
| 0 (this device) | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025 | — |
| +1 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 2026 | — |
| +2 | K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 10 | 0 |
| 1996 | 19 | 0 |
| 1997 | 8 | 0 |
| 1998 | 14 | 0 |
| 1999 | 10 | 0 |
| 2000 | 16 | 0 |
| 2001 | 26 | 0 |
| 2002 | 22 | 0 |
| 2003 | 14 | 0 |
| 2004 | 14 | 0 |
| 2005 | 21 | 0 |
| 2006 | 26 | 0 |
| 2007 | 9 | 0 |
| 2008 | 14 | 0 |
| 2009 | 11 | 0 |
| 2010 | 11 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Summary page 5…[email protected] Date Prepared: January 21, 2025 Primary Predicate Device: T2 Alpha Femur Retrograde Nailing System (K203819) Predicate Devices: Synthes Retrograde Femoral Nail Advanced System (K201346) GAP End… | 2021 |
| * | K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for…Summary page 5…2025 Primary Predicate Device: T2 Alpha Femur Retrograde Nailing System (K203819) Predicate Devices: Synthes Retrograde Femoral Nail Advanced System (K201346) GAP Endo-Exo Medullary System (K160545) Pangea Femur Plating Syste… | 2020 |
| * | K160545 | Gap Endo-Exo Medullary SystemSummary page 5…System (K203819) Predicate Devices: Synthes Retrograde Femoral Nail Advanced System (K201346) GAP Endo-Exo Medullary System (K160545) Pangea Femur Plating System (K231262) Device Description: T2 Alpha Femur Retrograde N… | 2016 |
| * | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Summary page 5…Femoral Nail Advanced System (K201346) GAP Endo-Exo Medullary System (K160545) Pangea Femur Plating System (K231262) Device Description: T2 Alpha Femur Retrograde Nailing System, previously cleared in K… | 2023 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | 2026 | 1 |
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 29 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- 85 of the 331 ancestors have a recall of any class.
- Of its descendants, K253640 (Stryker GmbH, 2026) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K203819.
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 indications for use of these internal fixation devices include:
- Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures and tumor resections
- Supracondylar fractures, including those with intraarticular extension
- Fractures involving osteopenic and osteoporotic bone
- Fractures distal to a total hip prosthesis
- Periprosthetic fractures
- Nonunions and malunions
The struts of the T2 Alpha Femur Retrograde Nailing System are intended to be used only with the nails of this system; they are not to be used as stand-alone devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250163: T2 Alpha Femur Retrograde 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/K250163
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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