510(k) · Cleared
ClearedAcumed Small Bone IM Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acumed, LLC · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 5, 2015 as substantially equivalent to K971783 (Synthes (Usa), 1997) and 2 other predicates after an 83-day review. Its family tree reaches back 4 generations to 1996. 10 later devices descend from it.
- Decided
- Feb 5, 2015
- Review
- 83 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K960642 (1996). 11 ancestors in all, the oldest K913949 (1992). 10 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK960642 Nancy NailLandos, Inc. · 1996
- 3 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 2 generations backK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
- 1 generation backK082148 Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line…Synthes (Usa) · 2008
- This deviceK143276 Acumed Small Bone IM Nail SystemAcumed, LLC · 2015
- Descendant · cites it directly · 4 of its ownK172943 Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
- Descendant · 2 generations on · 3 of its ownK202858 Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · Recalled
- Descendant · 3 generations on · 1 of its ownK212030 Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021
- Descendant · cites it directly · 1 of its ownK163014 AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017
- Descendant · 4 generations on · 0 of its ownK252961 Fusion FibFix NailFusion Orthopedics USA, LLC · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017 · cites it directly4descendants
- K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · 2 generations on3descendants
- K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021 · 3 generations on1descendant
- K163014AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017 · cites it directly1descendant
- K252961Fusion FibFix NailFusion Orthopedics USA, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −3 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −2 | K081452 | Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System | Synthes (Usa) | 2008 | — |
| −1 | K082148 | Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension | Synthes (Usa) | 2008 | — |
| 0 (this device) | K143276 | Acumed Small Bone IM Nail System | Acumed, LLC | 2015 | — |
| +1 | K172943 | Flex-Thread Fibula Pin System | Intrafuse, LLC | 2017 | — |
| +2 | K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | Conventus Orthopaedics, LLC | 2021 | 2 |
| +3 | K212030 | Flex-Thread™ Distal Fibula lntramedullary Nail System | Flower Orthopedics Corporation Dba Conventus Flower | 2021 | — |
| +1 | K163014 | AOS Small Bone Nailing System | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017 | — |
| +4 | K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 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? (3)
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 |
|---|---|---|---|
| * | K971783 | Synthes Elastic Intramedullary Nail (Ein) SystemSummary page 4…ation Rod Class: Class II Product Code: HSB Legally Marketed Predicate Device(s) The Synthes Elastic Intramedullary Nail (EIN), cleared in 1997 (K971783), the Synthes EIN End Cap, cleared in 2008 (K082148), and the Acumed Small Bone Locking Rod System II, cleared in 2003 (K031438)… | 1997 |
| * | K082148 | Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSummary page 4…de: HSB Legally Marketed Predicate Device(s) The Synthes Elastic Intramedullary Nail (EIN), cleared in 1997 (K971783), the Synthes EIN End Cap, cleared in 2008 (K082148), and the Acumed Small Bone Locking Rod System II, cleared in 2003 (K031438) serve as the predicate devices. Device Description… | 2008 |
| * | K031438 | Acumed Small Bone Locking Rod System IISummary page 4…tramedullary Nail (EIN), cleared in 1997 (K971783), the Synthes EIN End Cap, cleared in 2008 (K082148), and the Acumed Small Bone Locking Rod System II, cleared in 2003 (K031438) serve as the predicate devices. Device Description The Acumed Small Bone IM Nail is a titanium alloy (Ti-6Al-4V) intramedullar… | 2003 |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K172943 (Intrafuse, LLC, 2017) has gone furthest, with 4 descendants of its own.
- 12 other devices also cite its predicate K971783.
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. 2015, 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 Acumed Small Bone IM Nail System is intended for fixation of fractures and osteotomies of the fibula, radius, and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143276 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143276: Acumed Small Bone IM 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/K143276
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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