510(k) · Cleared
ClearedArtemis Proximal Femoral Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glw, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 19, 2021 as substantially equivalent to K043431 (Howmedica Osteonics Corp., 2005) after a 269-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Feb 19, 2021
- Review
- 269 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013468 (2001). 4 ancestors in all. 1 later device descends from it, 1 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 deviceK201379 Artemis Proximal Femoral Nail SystemGlw, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK221489 Artemis Proximal Femoral Nail SystemGlw, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221489Artemis Proximal Femoral Nail SystemGlw, Inc. · 2022 · cites it directly0descendants
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) | K201379 | Artemis Proximal Femoral Nail System | Glw, Inc. | 2021 | — |
| +1 | K221489 | Artemis Proximal Femoral Nail System | Glw, Inc. | 2022 | — |
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 |
|---|---|---|
| 2022 | 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 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? (1)
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 4…medullary fixation rod 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Device Panel Orthopedic Primary Predicate K043431 Gamma3 Trochanteric Nail Reference Predicate K173652 Piccolo Composite Nailing System… | 2005 |
| † | K173652 | Piccolo Composite Nailing System | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221489 | Artemis Proximal Femoral Nail System | 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 20 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K221489 (Glw, Inc., 2022) has gone furthest, with 0 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. 2021, 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 Artemis Proximal Femoral Nail System is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201379 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201379: Artemis Proximal Femoral 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/K201379
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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