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 Oct 27, 2022 as substantially equivalent to K201379 (Glw, Inc., 2021) and 4 other predicates after a 157-day review. Its family tree reaches back 8 generations to 1979.
- Decided
- Oct 27, 2022
- Review
- 157 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K792022 (1979). 63 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 7 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 6 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 5 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 4 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 3 generations backK123672 Inion Freedomscrew (Alternative Marketing Name: Inion Otps…Inion OY · 2013
- 2 generations backK160304 OsteoBullet Compression ScrewPhalanx Innovations · 2016
- 1 generation backK200291 CREED™ Cannulated ScrewsGlw Medical, Inc. · 2020
- This deviceK221489 Artemis Proximal Femoral Nail SystemGlw, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −7 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −6 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −5 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −4 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −3 | K123672 | Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) | Inion OY | 2013 | — |
| −2 | K160304 | OsteoBullet Compression Screw | Phalanx Innovations | 2016 | — |
| −1 | K200291 | CREED™ Cannulated Screws | Glw Medical, Inc. | 2020 | — |
| 0 (this device) | K221489 | Artemis Proximal Femoral Nail System | Glw, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K201379 | Artemis Proximal Femoral Nail SystemSummary page 4…y and accessories HWC: Screw, fixation, bone Predicate Device (primary) 510(k) # Manufacturer Artemis Proximal Femoral Nail K201379 GLW Medical Innovation System Predicate Device (additional) 510(k) # Manufacturer Gamma 3 TNail System… | 2021 |
| * | K043431 | GAMMA3 Nail SystemSummary page 4…Femoral Nail K201379 GLW Medical Innovation System Predicate Device (additional) 510(k) # Manufacturer Gamma 3 TNail System K043431 Stryker Apollo Ankle Plating System K213005 GLW Medical Innovation CREED Cannulated Screws… | 2005 |
| * | K213005 | Apollo Ankle Fracture Plating SystemSummary page 4…stem Predicate Device (additional) 510(k) # Manufacturer Gamma 3 TNail System K043431 Stryker Apollo Ankle Plating System K213005 GLW Medical Innovation CREED Cannulated Screws K200291 GLW Medical Innovation Zimmer Biomet Affixu… | 2022 |
| * | K200291 | CREED™ Cannulated ScrewsSummary page 4…3 TNail System K043431 Stryker Apollo Ankle Plating System K213005 GLW Medical Innovation CREED Cannulated Screws K200291 GLW Medical Innovation Zimmer Biomet Affixus Hip K183162 Zimmer Biomet Fracture Nail Description… | 2020 |
| * | K183162 | Affixus Hip Fracture NailSummary page 4…System K213005 GLW Medical Innovation CREED Cannulated Screws K200291 GLW Medical Innovation Zimmer Biomet Affixus Hip K183162 Zimmer Biomet Fracture Nail Description The Artemis Proximal Femoral Nail System is an intramedullary fracture… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 43 years and passes through 8 companies; a new generation was cleared every 3.2 years on median.
- 16 of the 63 ancestors have a recall of any class.
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. 2022, 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.
Additionally, the long nail kit is indicated for the fixation of subtrochanteric fractures and shaft fracture extending distally to a point approximately 10 cm proximal to the intercondylar notch.
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/K221489 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221489: Artemis Proximal Femoral Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221489
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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