510(k) · Cleared
ClearedEZ-Fix Midshaft Humeral Intramedullary Rod System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biodynamic Technologies, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Aug 28, 1996 after a 58-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Aug 28, 1996
- Review
- 58 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK962553 EZ-Fix Midshaft Humeral Intramedullary Rod SystemBiodynamic Technologies, Inc. · 1996
- Descendant · cites it directly · 5 of its ownK980609 Segmental Defect Replacement SystemMetagen, LLC · 1998
- Descendant · 2 generations on · 3 of its ownK051965 Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation…Merete Medical GmbH · 2006
- Descendant · 3 generations on · 1 of its ownK142451 OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect…Merete Medical GmbH · 2015
- Descendant · 4 generations on · 0 of its ownK181026 OsteoBridge™ IDSF SystemMerete GmbH · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK101939 Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH · 2010 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K980609Segmental Defect Replacement SystemMetagen, LLC · 1998 · cites it directly5descendants
- K051965Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH · 2006 · 2 generations on3descendants
- K142451OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH · 2015 · 3 generations on1descendant
- K181026OsteoBridge™ IDSF SystemMerete GmbH · 2018 · 4 generations on0descendants
- K101939Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962553 | EZ-Fix Midshaft Humeral Intramedullary Rod System | Biodynamic Technologies, Inc. | 1996 | — |
| +1 | K980609 | Segmental Defect Replacement System | Metagen, LLC | 1998 | — |
| +2 | K051965 | Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System | Merete Medical GmbH | 2006 | — |
| +3 | K142451 | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod… | Merete Medical GmbH | 2015 | — |
| +4 | K181026 | OsteoBridge™ IDSF System | Merete GmbH | 2018 | 3 |
| +3 | K101939 | Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation System | Merete Medical GmbH | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | — | Orthologic® OrthoNall® Humeral Intramedullary Fixation Device Named without a submission number | |
| * | — | Applied Osteo Systems True/Flex™ Fixation Device Named without a submission number | |
| * | — | Howmedica Seidel™ Humeral Locking Nail System Named without a submission number | |
| * | — | Howmedica Alta® Humeral Rod Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980609 | Segmental Defect Replacement System | 1998 | 5 |
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, K980609 (Metagen, LLC, 1998) has gone furthest, with 5 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 | — |
What is it indicated for?
The EZ-Fix™ Midshaft Humeral Intramedullary Rod is an intemal skeletal fixation device indicated for intramedullary use to stabilize midshaft fractures of the humerus.
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/K962553 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962553: EZ-Fix Midshaft Humeral Intramedullary Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962553
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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