510(k) · Cleared
Recalled · Class II · 2019Femorotibial Medullary Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 12, 1986 after a 195-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Feb 12, 1986
- Review
- 195 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK853250 Femorotibial Medullary NailZimmer, Inc. · 1986
- Descendant · cites it directly · 3 of its ownK051965 Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation…Merete Medical GmbH · 2006
- Descendant · 2 generations on · 1 of its ownK142451 OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect…Merete Medical GmbH · 2015
- Descendant · 3 generations on · 0 of its ownK181026 OsteoBridge™ IDSF SystemMerete GmbH · 2018 · Recalled
- Descendant · cites it directly · 0 of its ownK101939 Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH · 2010 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K051965Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH · 2006 · cites it directly3descendants
- K142451OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH · 2015 · 2 generations on1descendant
- K181026OsteoBridge™ IDSF SystemMerete GmbH · 2018 · 3 generations on0descendants
- K101939Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K853250 | Femorotibial Medullary Nail | Zimmer, Inc. | 1986 | — |
| +1 | K051965 | Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System | Merete Medical GmbH | 2006 | — |
| +2 | K142451 | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod… | Merete Medical GmbH | 2015 | — |
| +3 | K181026 | OsteoBridge™ IDSF System | Merete GmbH | 2018 | 3 |
| +1 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0333-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051965 (Merete Medical GmbH, 2006) has gone furthest, with 3 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/K853250 · printed Nov 4, 2026
Cite this page
510(k) Report. “K853250: Femorotibial Medullary Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853250
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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