510(k) · Cleared
ClearedRod, Fixation, Intramedullary and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acu Med, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 6, 1995 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 36 later devices descend from it.
- Decided
- Jul 6, 1995
- Review
- 86 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 2 citing it directly.
- This deviceK951673 Rod, Fixation, Intramedullary and AccessoriesAcu Med, Inc. · 1995
- Descendant · cites it directly · 24 of its ownK031438 Acumed Small Bone Locking Rod System IIAcumed, LLC · 2003 · Recalled
- Descendant · 2 generations on · 15 of its ownK071944 Acumed Small Bone Locking System IIAcumed, LLC · 2007
- Descendant · 2 generations on · 10 of its ownK143276 Acumed Small Bone IM Nail SystemAcumed, LLC · 2015
- Descendant · 2 generations on · 10 of its ownK142945 Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc. · 2015
- Descendant · cites it directly · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K031438Acumed Small Bone Locking Rod System IIAcumed, LLC · 2003 · cites it directly24descendants
- K071944Acumed Small Bone Locking System IIAcumed, LLC · 2007 · 2 generations on15descendants
- K143276Acumed Small Bone IM Nail SystemAcumed, LLC · 2015 · 2 generations on10descendants
- K142945Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc. · 2015 · 2 generations on10descendants
- K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951673 | Rod, Fixation, Intramedullary and Accessories | Acu Med, Inc. | 1995 | — |
| +1 | K031438 | Acumed Small Bone Locking Rod System II | Acumed, LLC | 2003 | 1 |
| +2 | K071944 | Acumed Small Bone Locking System II | Acumed, LLC | 2007 | — |
| +2 | K143276 | Acumed Small Bone IM Nail System | Acumed, LLC | 2015 | — |
| +2 | K142945 | Sonoma Fibula Repair System | Sonoma Orthopedic Products, Inc. | 2015 | — |
| +1 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (36)
See all 362 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?
- Of its descendants, K031438 (Acumed, LLC, 2003) has gone furthest, with 24 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K951673 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951673: Rod, Fixation, Intramedullary and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951673
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026