510(k) · Cleared
Recalled · Class II · 2025Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial 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 Feb 11, 2022 as substantially equivalent to K200869 (Stryker Trauma GmbH, 2020) and 3 other predicates after a 129-day review. Its family tree reaches back 9 generations to 1997. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 11, 2022
- Review
- 129 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 9 generations to K970097 (1997). 61 ancestors in all, the oldest K871539 (1987). 3 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 5 generations between
- 3 generations backK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- 2 generations backK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
- 1 generation backK193308 T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH · 2020
- This deviceK213328 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing…Stryker GmbH · 2022
- Descendant · cites it directly · 0 of its ownK251400 T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH · 2025
- Descendant · cites it directly · 0 of its ownK230512 Gamma4 SystemStryker GmbH · 2023
- Descendant · cites it directly · 0 of its ownK222309 Gamma4 SystemStryker GmbH · 2022
Show all 9 generations
- Root · 9 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 8 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 7 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 6 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 5 generations backK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
- 4 generations backK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
- 3 generations backK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- 2 generations backK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
- 1 generation backK193308 T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH · 2020
- This deviceK213328 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing…Stryker GmbH · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −8 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −7 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −6 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −5 | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | 16 |
| −4 | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN… | Stryker Trauma GmbH | 2018 | — |
| −3 | 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 | — |
| −1 | K193308 | T2 Alpha Tibia Nailing System, IMN Screws System | Stryker Trauma GmbH | 2020 | — |
| 0 (this device) | K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System | Stryker GmbH | 2022 | — |
| +1 | K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH | 2025 | — |
| +1 | K230512 | Gamma4 System | Stryker GmbH | 2023 | — |
| +1 | K222309 | Gamma4 System | Stryker GmbH | 2022 | — |
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 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K200869 | Gamma3 SystemSummary page 8…(Rod, fixation, intramedullary and accessories) Regulatory Class: Class II III. PREDICATE DEVICE Primary Predicate: Gamma3 System (K200869) Additional Predicates: T2 Alpha Femur Antegrade GT/PF Nailing System (K2038… | 2020 |
| * | K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Summary page 8…cate: Gamma3 System (K200869) Additional Predicates: T2 Alpha Femur Antegrade GT/PF Nailing System (K203819) Zimmer Natural Nail System Cephalomedullary Nails (K19… | 2021 |
| * | K192312 | Zimmer Natural Nail System Cephalomedullary NailsSummary page 8…(K203819) Zimmer Natural Nail System Cephalomedullary Nails (K192312) IMN Screws System (K193308) T2 Tibial Nailing System (… | 2019 |
| * | K193308 | T2 Alpha Tibia Nailing System, IMN Screws SystemSummary page 8…Zimmer Natural Nail System Cephalomedullary Nails (K192312) IMN Screws System (K193308) T2 Tibial Nailing System (K203819)… | 2020 |
What descends from it? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2025 | Class II | Z-1914-2025 | Process design | Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 31 of the 61 ancestors have a recall of any class.
- Of its descendants, K251400 (Stryker GmbH, 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K200869.
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. 2022, 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 Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone). The Gamma3 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the…
Read the full statement (207 words)
The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).
The Gamma3 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).
The U-Blade Lag Screw is also indicated for rotationally unstable fractures.
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked.
The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
• Open and closed tibial fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Nonunion and malunion
The Locking Screws may also be used in conjunction with the T2 Alpha Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial 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/K213328
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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