510(k) · Cleared
ClearedAdvanced Intramedullary Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Double Medical Technology, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 21, 2022 as substantially equivalent to K143276 (Acumed, LLC, 2015) and 1 other predicate after a 238-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Dec 21, 2022
- Review
- 238 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K960642 (1996). 15 ancestors in all, the oldest K913949 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK960642 Nancy NailLandos, Inc. · 1996
- 4 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 3 generations backK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
- 2 generations backK082148 Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line…Synthes (Usa) · 2008
- 1 generation backK143276 Acumed Small Bone IM Nail SystemAcumed, LLC · 2015
- This deviceK221221 Advanced Intramedullary Nail SystemDouble Medical Technology, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −4 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −3 | K081452 | Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System | Synthes (Usa) | 2008 | — |
| −2 | K082148 | Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension | Synthes (Usa) | 2008 | — |
| −1 | K143276 | Acumed Small Bone IM Nail System | Acumed, LLC | 2015 | — |
| 0 (this device) | K221221 | Advanced Intramedullary Nail System | Double Medical Technology, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K143276 | Acumed Small Bone IM Nail SystemSummary page 4…II Classification panel Orthopedic 3. Predicate Device Primary predicate device: Legally marketed K143276 Acumed Small Bone IM Nail System device(s) to which Additional predicate devices: equivalence is c… | 2015 |
| * | K043052 | Trigen Hindfoot Fusion NailSummary page 4…76 Acumed Small Bone IM Nail System device(s) to which Additional predicate devices: equivalence is claimed K043052 TriGen Hindfoot Fusion Nail Reason for 510(k) New device (Implant) submission 4. Device Description The method of… | 2004 |
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 26 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- 4 of the 15 ancestors have a recall of any class.
- 4 other devices also cite its predicate K143276.
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?
Advanced Intramedullary Nail System is intended to be implanted into the medullary canal of limbs for alignment, stabilization, fixation of fractures caused by trauma or diseases. Indications: 1.Ulna Nail: Indicated for the fixation of fractures and osteotomies of the ulna. 2.Fibular Nail: Indicated for fixation of fractures and osteotomies of the fibula. 3.Ankle Fusion Nail: Indicated for degeneration,deformity, or trauma of both the tibiotalar and…
Read the full statement (123 words)
Advanced Intramedullary Nail System is intended to be implanted into the medullary canal of limbs for alignment, stabilization, fixation of fractures caused by trauma or diseases.
Indications:
1.Ulna Nail: Indicated for the fixation of fractures and osteotomies of the ulna.
2.Fibular Nail: Indicated for fixation of fractures and osteotomies of the fibula.
3.Ankle Fusion Nail: Indicated for degeneration,deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot: tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and subtalar joints; avascular necrosis of the ankle and subtalar joints; failed total ankle replacement with subtalar intrusion;failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221221: Advanced Intramedullary 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/K221221
Report an extraction error
Are you the manufacturer?
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