510(k) · Cleared
Recalled · Class II · 2016GAMMA3 and T2 Recon Targeting Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Trauma AG · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jan 23, 2013 as substantially equivalent to K043431 (Howmedica Osteonics Corp., 2005) and 1 other predicate after a 79-day review. Its family tree reaches back 3 generations to 2001. 20 later devices descend from it. It has been recalled once.
- Decided
- Jan 23, 2013
- Review
- 79 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K013468 (2001). 5 ancestors in all. 20 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK013468 Long Length Dyax NailHowmedica Osteonics Corp. · 2001 · Recalled
- 2 generations backK034002 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2004 · Recalled
- 1 generation backK043431 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2005
- This deviceK123401 GAMMA3 and T2 Recon Targeting DevicesStryker Trauma AG · 2013
- Descendant · cites it directly · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
- Descendant · 2 generations on · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- Descendant · 3 generations on · 15 of its ownK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
- Descendant · cites it directly · 9 of its ownK200869 Gamma3 SystemStryker Trauma GmbH · 2020
- Descendant · 4 generations on · 7 of its ownK203819 T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade…Stryker GmbH · 2021
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · cites it directly17descendants
- K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · 2 generations on16descendants
- K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH · 2019 · 3 generations on15descendants
- K200869Gamma3 SystemStryker Trauma GmbH · 2020 · cites it directly9descendants
- K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH · 2021 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013468 | Long Length Dyax Nail | Howmedica Osteonics Corp. | 2001 | 1 |
| −2 | K034002 | GAMMA3 Nail System | Howmedica Osteonics Corp. | 2004 | 2 |
| −1 | K043431 | GAMMA3 Nail System | Howmedica Osteonics Corp. | 2005 | — |
| 0 (this device) | K123401 | GAMMA3 and T2 Recon Targeting Devices | Stryker Trauma AG | 2013 | — |
| +1 | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN… | Stryker Trauma GmbH | 2018 | — |
| +2 | 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 | — |
| +1 | K200869 | Gamma3 System | Stryker Trauma GmbH | 2020 | — |
| +4 | K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF… | Stryker GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K043431 | GAMMA3 Nail SystemSummary page 1…510(k) submission is being supplied to the US FDA to address modifications made to the Gamma3 Target Device and addition of a new Distal Targeting Device to the Gamma3 (K04343 1) and T2 Recon Nail Systems (K1 02992) as well as the inclusion of the existing target devices in the Gamma3 and T2 Recon Nail Sys… | 2005 |
| * | K102992 | T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 DegreesSummary page 1…to the US FDA to address modifications made to the Gamma3 Target Device and addition of a new Distal Targeting Device to the Gamma3 (K04343 1) and T2 Recon Nail Systems (K1 02992) as well as the inclusion of the existing target devices in the Gamma3 and T2 Recon Nail Systems. Intended Use The Gamma3 Target… | 2010 |
What descends from it? (20)
See all 203 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 |
|---|---|---|---|---|
| Jan 21, 2016 | Class II | Z-0870-2016 | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K172774 (Stryker Trauma GmbH, 2018) has gone furthest, with 17 descendants of its own.
- 15 other devices also cite its predicate K043431.
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. 2013, 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 Gamma3 Target Devices are intended for use with the Trochanteric Nail or Long Length Gamma3 Nail. The Gamma3 and T2 Recon Distal Targeting Devices are intended for use with the Long Length Gamma3 Nail and T2 Recon Nail System. Gamma3 Nail System The Troehanteric Gamma3 Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3…
Read the full statement (144 words)
The Gamma3 Target Devices are intended for use with the Trochanteric Nail or Long Length Gamma3 Nail.
The Gamma3 and T2 Recon Distal Targeting Devices are intended for use with the Long Length Gamma3 Nail and T2 Recon Nail System.
Gamma3 Nail System
The Troehanteric Gamma3 Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3 Nail inidcation may include fractures resulsting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.
T2 Recon Nail System
The T2 Recon Nail System indications include fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123401: GAMMA3 and T2 Recon Targeting Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123401
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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