510(k) · Cleared
Recalled · Class II · 2020Gamma 3 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 Aug 8, 2003 after a 17-day review. The FDA summary names its predicate without a number. 78 later devices descend from it. It has been recalled 7 times.
- Decided
- Aug 8, 2003
- Review
- 17 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 7
- Predicates
- 0
78 later devices descend from it, 7 citing it directly.
- This deviceK032244 Gamma 3 Nail SystemHowmedica Osteonics Corp. · 2003
- Descendant · cites it directly · 69 of its ownK034002 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2004 · Recalled
- Descendant · cites it directly · 48 of its ownK043431 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2005
- Descendant · 2 generations on · 37 of its ownK102992 T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130…Howmedica Osteonics Corp. · 2010
- Descendant · 2 generations on · 20 of its ownK123401 GAMMA3 and T2 Recon Targeting DevicesStryker Trauma AG · 2013 · Recalled
- Descendant · 3 generations on · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K034002GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2004 · cites it directly69descendants
- K043431GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2005 · cites it directly48descendants
- K102992T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 DegreesHowmedica Osteonics Corp. · 2010 · 2 generations on37descendants
- K123401GAMMA3 and T2 Recon Targeting DevicesStryker Trauma AG · 2013 · 2 generations on20descendants
- K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032244 | Gamma 3 Nail System | Howmedica Osteonics Corp. | 2003 | — |
| +1 | K034002 | GAMMA3 Nail System | Howmedica Osteonics Corp. | 2004 | 2 |
| +1 | K043431 | GAMMA3 Nail System | Howmedica Osteonics Corp. | 2005 | — |
| +2 | K102992 | T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 Degrees | Howmedica Osteonics Corp. | 2010 | — |
| +2 | K123401 | GAMMA3 and T2 Recon Targeting Devices | Stryker Trauma AG | 2013 | 1 |
| +3 | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN… | Stryker Trauma GmbH | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | — | Trochanteric Dyax Nail System Named without a submission number | |
| * | — | Gamma Nail System Named without a submission number |
What descends from it? (78)
See all 787 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K034002 | GAMMA3 Nail System | 2004 | 69 |
| K043431 | GAMMA3 Nail System | 2005 | 48 |
| K103400 | Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube Clip | 2011 | 5 |
| K140601 | Flow-Nail | 2014 | 2 |
| K111352 | Talon Distalfix Proximal Femoral Nail | 2011 | 1 |
| K201147 | Elos® Intramedullary Nailing System | 2021 | 0 |
| K133104 | Van Hip Fracture System | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2020 | Class II | Z-2382-2020 | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| May 7, 2020 | Class II | Z-2385-2020 | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| May 7, 2020 | Class II | Z-2386-2020 | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| May 7, 2020 | Class II | Z-2384-2020 | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| May 7, 2020 | Class II | Z-2387-2020 | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| May 7, 2020 | Class II | Z-2379-2020 | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| May 7, 2020 | Class II | Z-2381-2020 | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K034002 (Howmedica Osteonics Corp., 2004) has gone furthest, with 69 descendants of its own.
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 intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Dyax and Gamma Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032244 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032244: Gamma 3 Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032244
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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