510(k) · Cleared
Recalled · 2010GAMMA3 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 Jan 15, 2004 as substantially equivalent to K013468 (Howmedica Osteonics Corp., 2001) and 1 other predicate after a 22-day review. Its family tree reaches back 1 generation to 2001. 69 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 15, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K013468 (2001). 2 ancestors in all. 69 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK013468 Long Length Dyax NailHowmedica Osteonics Corp. · 2001 · Recalled
- This deviceK034002 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2004
- Descendant · cites it directly · 48 of its ownK043431 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 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 · 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
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K043431GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2005 · cites it directly48descendants
- K102992T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 DegreesHowmedica Osteonics Corp. · 2010 · cites it directly37descendants
- 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 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013468 | Long Length Dyax Nail | Howmedica Osteonics Corp. | 2001 | 1 |
| 0 (this device) | K034002 | GAMMA3 Nail System | Howmedica Osteonics Corp. | 2004 | — |
| +1 | K043431 | GAMMA3 Nail System | Howmedica Osteonics Corp. | 2005 | — |
| +1 | 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 |
| +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 | — |
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 |
|---|---|---|
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 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 |
|---|---|---|---|
| * | K013468 | Long Length Dyax NailSummary page 1…1 CFR §888.3020 This Special 510(k) submission is a line extension intended to address modifications to the Gamma- Ti Nail System and the Gamma3 Nail System cleared in K013468 and K032244 respectively. The new components in the Gamma3 Nail System include additional sizes of Trochanteric Nails, Long Nails… | 2001 |
| * | K032244 | Gamma 3 Nail SystemSummary page 1…020 This Special 510(k) submission is a line extension intended to address modifications to the Gamma- Ti Nail System and the Gamma3 Nail System cleared in K013468 and K032244 respectively. The new components in the Gamma3 Nail System include additional sizes of Trochanteric Nails, Long Nails, shorter La… | 2003 |
What descends from it? (69)
See all 697 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043431 | GAMMA3 Nail System | 2005 | 48 |
| K102992 | T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 Degrees | 2010 | 37 |
| K200869 | Gamma3 System | 2020 | 9 |
| K111352 | Talon Distalfix Proximal Femoral Nail | 2011 | 1 |
| K043233 | Gotfried Physiological Hip (PH) Nail | 2005 | 1 |
| K201147 | Elos® Intramedullary Nailing System | 2021 | 0 |
| K150769 | Cardinal Health Trochanteric IM Nail System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 23, 2010 | Not classified | Z-2340-2010 | Process control | The nail has no thread for the set screw hindering insertion. |
| Nov 22, 2004 | Not classified | Z-0241-06 | Other | The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K043431 (Howmedica Osteonics Corp., 2005) has gone furthest, with 48 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?
Gamma3 Trochanteric Nail The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Gamma-Ti and Gamma ® Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur. Long Length Gamma3 Nail The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm…
Read the full statement (109 words)
Gamma3 Trochanteric Nail
The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Gamma-Ti and Gamma ® Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.
Long Length Gamma3 Nail
The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, mal-union, pathological fractures, and impending pathological fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034002 · printed Nov 3, 2026
Cite this page
510(k) Report. “K034002: GAMMA3 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/K034002
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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