510(k) · Cleared
ClearedGAMMA3 Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 16, 2005 as substantially equivalent to K034002 (Howmedica Osteonics Corp., 2004) and 1 other predicate after a 65-day review. Its family tree reaches back 2 generations to 2001. 48 later devices descend from it.
- Decided
- Feb 16, 2005
- Review
- 65 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K013468 (2001). 3 ancestors in all. 48 later devices descend from it, 16 citing it directly.
- Root · 2 generations backK013468 Long Length Dyax NailHowmedica Osteonics Corp. · 2001 · Recalled
- 1 generation backK034002 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2004 · Recalled
- This deviceK043431 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 20 of its ownK123401 GAMMA3 and T2 Recon Targeting DevicesStryker Trauma AG · 2013 · Recalled
- Descendant · 2 generations on · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
- Descendant · 3 generations on · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- Descendant · 4 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
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K123401GAMMA3 and T2 Recon Targeting DevicesStryker Trauma AG · 2013 · cites it directly20descendants
- K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · 2 generations on17descendants
- K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · 3 generations on16descendants
- K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH · 2019 · 4 generations on15descendants
- K200869Gamma3 SystemStryker Trauma GmbH · 2020 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013468 | Long Length Dyax Nail | Howmedica Osteonics Corp. | 2001 | 1 |
| −1 | K034002 | GAMMA3 Nail System | Howmedica Osteonics Corp. | 2004 | 2 |
| 0 (this device) | K043431 | GAMMA3 Nail System | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K123401 | GAMMA3 and T2 Recon Targeting Devices | Stryker Trauma AG | 2013 | 1 |
| +2 | 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 | — |
| +4 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K034002 | GAMMA3 Nail SystemSummary page 1…21 CFR §888.3020 Device Product Code: 87 HSB Predicate Device: Gamnma3®gNail System, K034002 and K032244 Description The Gamma3® Nail System is a family of intramedullary nails for basilar neck, intertrochanteric, subtroc… | 2004 |
| * | K032244 | Gamma 3 Nail SystemSummary page 1…21 CFR §888.3020 Device Product Code: 87 HSB Predicate Device: Gamnma3®gNail System, K034002 and K032244 Description The Gamma3® Nail System is a family of intramedullary nails for basilar neck, intertrochanteric, subtrochanteric and… | 2003 |
What descends from it? (48)
See all 4816 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123401 | GAMMA3 and T2 Recon Targeting Devices | 2013 | 20 |
| K200869 | Gamma3 System | 2020 | 9 |
| K100238 | HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MM | 2010 | 7 |
| K172830 | Double Medical Femoral Nail System | 2018 | 2 |
| K171108 | AUTOBAHN Nailing System | 2017 | 2 |
| K151010 | Piccolo Composite Nailing System | 2015 | 2 |
| K150655 | OIC Intramedullary Nail System | 2015 | 2 |
| K201379 | Artemis Proximal Femoral Nail System | 2021 | 1 |
| K161466 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System | 2017 | 1 |
| K153536 | Piccolo Composite® Nailing System | 2016 | 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 4 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K123401 (Stryker Trauma AG, 2013) has gone furthest, with 20 descendants of its own.
- 6 other devices also cite its predicate K034002.
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.
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 Trochanteric 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 indications may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures. The Gamma3® U-Blade Lag Screw may be used with either the Gamma3®…
Read the full statement (96 words)
The Trochanteric 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 indications may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.
The Gamma3® U-Blade Lag Screw may be used with either the Gamma3® Trochanteric Nail or the Long Length Gamma3® Nail to treat patients with highly osteoporotic bone or metastatic disease in the femoral head, short femoral head/neck fragments, or unstable intertrochanteric fractures with missing medial-caudal bone support.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043431: GAMMA3 Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043431
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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