510(k) · Cleared
ClearedGamma3 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Trauma GmbH · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 22, 2020 as substantially equivalent to K123401 (Stryker Trauma AG, 2013) and 5 other predicates after a 112-day review. Its family tree reaches back 8 generations to 1997. 9 later devices descend from it.
- Decided
- Jul 22, 2020
- Review
- 112 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K970097 (1997). 41 ancestors in all, the oldest K871539 (1987). 9 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 7 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 6 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 5 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 4 generations backK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
- 3 generations backK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
- 2 generations backK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- 1 generation backK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
- This deviceK200869 Gamma3 SystemStryker Trauma GmbH · 2020
- Descendant · cites it directly · 3 of its ownK213328 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing…Stryker GmbH · 2022 · Recalled
- Descendant · cites it directly · 1 of its ownK242247 ARIX Femur Nail SystemJeil Medical Corporation · 2025
- Descendant · cites it directly · 0 of its ownK261043 AUTOBAHN™ Nailing SystemGlobus Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252826 ARIX Femur Nail SystemJeil Medical Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK251400 T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH · 2022 · cites it directly3descendants
- K242247ARIX Femur Nail SystemJeil Medical Corporation · 2025 · cites it directly1descendant
- K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc. · 2026 · cites it directly0descendants
- K252826ARIX Femur Nail SystemJeil Medical Corporation · 2025 · cites it directly0descendants
- K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −7 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −6 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −5 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −4 | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | 16 |
| −3 | 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 | — |
| −1 | K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System… | Stryker Trauma GmbH | 2019 | — |
| 0 (this device) | K200869 | Gamma3 System | Stryker Trauma GmbH | 2020 | — |
| +1 | K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System | Stryker GmbH | 2022 | 1 |
| +1 | K242247 | ARIX Femur Nail System | Jeil Medical Corporation | 2025 | — |
| +1 | K261043 | AUTOBAHN™ Nailing System | Globus Medical, Inc. | 2026 | — |
| +1 | K252826 | ARIX Femur Nail System | Jeil Medical Corporation | 2025 | — |
| +2 | K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 K253640 T2 Alpha Femur Retrograde Nailing System…score 19.8 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K123401 | GAMMA3 and T2 Recon Targeting DevicesSummary page 4…Fax: 201-831-6020 Date Prepared: March 31, 2020 Primary Predicate: Gamma3 and T2 Recon Targeting Devices (K123401) Additional Predicates: T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha… | 2013 |
| * | K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Summary page 4…/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System (K191271) Zimmer Natural Nail System (K172114) Trigen InterT… | 2019 |
| * | K172114 | Zimmer Natural Nail SystemSummary page 4…ling System, IMN Screws System, IMN Instruments System (K191271) Zimmer Natural Nail System (K172114) Trigen InterTAN (K040212) Howmedica Gamma3 Nail Sy… | 2017 |
| * | K040212 | Trigen IntertanSummary page 4…System (K191271) Zimmer Natural Nail System (K172114) Trigen InterTAN (K040212) Howmedica Gamma3 Nail System (K043431 and K034002) Description The Gamma3 System consis… | 2004 |
| * | K043431 | GAMMA3 Nail SystemSummary page 4…immer Natural Nail System (K172114) Trigen InterTAN (K040212) Howmedica Gamma3 Nail System (K043431 and K034002) Description The Gamma3 System consists of Trochanteric Nails, Long Nails, standard Lag Screws, U-Blade Lag Screws,… | 2005 |
| * | K034002 | GAMMA3 Nail SystemSummary page 4…l Nail System (K172114) Trigen InterTAN (K040212) Howmedica Gamma3 Nail System (K043431 and K034002) Description The Gamma3 System consists of Trochanteric Nails, Long Nails, standard Lag Screws, U-Blade Lag Screws, end caps, s… | 2004 |
What descends from it? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System | 2022 | 3 |
| K242247 | ARIX Femur Nail System | 2025 | 1 |
| K261043 | AUTOBAHN™ Nailing System | 2026 | 0 |
| K252826 | ARIX Femur Nail System | 2025 | 0 |
| K233134 | I.T.S. INS Proximal Femur Nail | 2024 | 0 |
| K221021 | Femoral Trochanteric Nail System – Neonail | 2022 | 0 |
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 23 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 21 of the 41 ancestors have a recall of any class.
- Of its descendants, K213328 (Stryker GmbH, 2022) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K123401.
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. 2020, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200869: Gamma3 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200869
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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