510(k) · Cleared
ClearedAcumed Small Bone Locking System II
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 Aug 9, 2007 as substantially equivalent to K031438 (Acumed, LLC, 2003) after a 27-day review. Its family tree reaches back 2 generations to 1992. 15 later devices descend from it.
- Decided
- Aug 9, 2007
- Review
- 27 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913949 (1992). 4 ancestors in all. 15 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK913949 True/Flex Humerus, Ulna & Radius Intramed Rods SysApplied Osteo Systems, Inc. · 1992
- 1 generation backK031438 Acumed Small Bone Locking Rod System IIAcumed, LLC · 2003 · Recalled
- This deviceK071944 Acumed Small Bone Locking System IIAcumed, LLC · 2007
- Descendant · cites it directly · 10 of its ownK142945 Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc. · 2015
- Descendant · cites it directly · 9 of its ownK160069 Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc. · 2016
- 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 · 2 generations on · 3 of its ownK173656 Arthrex FibuLock NailArthrex, Inc. · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K142945Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc. · 2015 · cites it directly10descendants
- K160069Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc. · 2016 · cites it directly9descendants
- K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017 · cites it directly4descendants
- K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · 2 generations on3descendants
- K173656Arthrex FibuLock NailArthrex, Inc. · 2018 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913949 | True/Flex Humerus, Ulna & Radius Intramed Rods Sys | Applied Osteo Systems, Inc. | 1992 | — |
| −1 | K031438 | Acumed Small Bone Locking Rod System II | Acumed, LLC | 2003 | 1 |
| 0 (this device) | K071944 | Acumed Small Bone Locking System II | Acumed, LLC | 2007 | — |
| +1 | K142945 | Sonoma Fibula Repair System | Sonoma Orthopedic Products, Inc. | 2015 | — |
| +1 | K160069 | Sonoma Fibula Repair System | Sonoma Orthopedics Products, Inc. | 2016 | — |
| +1 | K172943 | Flex-Thread Fibula Pin System | Intrafuse, LLC | 2017 | — |
| +2 | K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | Conventus Orthopaedics, LLC | 2021 | 2 |
| +2 | K173656 | Arthrex FibuLock Nail | Arthrex, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K031438 | Acumed Small Bone Locking Rod System IISummary page 1…Class II, 21 CFR 888.3020 Device Product Code: HSB Legally Marketed Equivalent Device(s): Acumed Small Bone Locking Rod System II K031438 Device Description: The Acumed Small Bone Locking Rod II is an intramedullary rod with solid and cannulated versions. Rods are m… | 2003 |
What descends from it? (15)
See all 155 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 15 years and passes through 2 companies; a new generation was cleared every 11.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K142945 (Sonoma Orthopedic Products, Inc., 2015) has gone furthest, with 10 descendants of its own.
- 8 other devices also cite its predicate K031438.
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. 2007, 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 Locking Rod System II includes rods and screws, with accessories, for indicated use for fractures and osteotomies of the radius, ulna, and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071944 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071944: Acumed Small Bone Locking System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071944
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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