510(k) · Cleared
ClearedOsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merete Medical GmbH · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 9, 2015 as substantially equivalent to K051965 (Merete Medical GmbH, 2006) and 1 other predicate after a 160-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Feb 9, 2015
- Review
- 160 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K962553 (1996). 12 ancestors in all, the oldest K853250 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK962553 EZ-Fix Midshaft Humeral Intramedullary Rod SystemBiodynamic Technologies, Inc. · 1996
- 2 generations backK980609 Segmental Defect Replacement SystemMetagen, LLC · 1998
- 1 generation backK051965 Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation…Merete Medical GmbH · 2006
- This deviceK142451 OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect…Merete Medical GmbH · 2015
- Descendant · cites it directly · 0 of its ownK181026 OsteoBridge™ IDSF SystemMerete GmbH · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K181026OsteoBridge™ IDSF SystemMerete GmbH · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962553 | EZ-Fix Midshaft Humeral Intramedullary Rod System | Biodynamic Technologies, Inc. | 1996 | — |
| −2 | K980609 | Segmental Defect Replacement System | Metagen, LLC | 1998 | — |
| −1 | K051965 | Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System | Merete Medical GmbH | 2006 | — |
| 0 (this device) | K142451 | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod… | Merete Medical GmbH | 2015 | — |
| +1 | K181026 | OsteoBridge™ IDSF System | Merete GmbH | 2018 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K051965 | Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemSummary page 3…Page 1/1 ™ 510(k) Submission – OsteoBridge IDSF- Extension to 510(k) Submission K051965 and K113303 1. Indications for Use Statement Indications for Use 510(k) Number (if… | 2006 |
| * | K113303 | Osleobridge Idsf Spacer ConectorSummary page 3…Page 1/1 ™ 510(k) Submission – OsteoBridge IDSF- Extension to 510(k) Submission K051965 and K113303 1. Indications for Use Statement Indications for Use 510(k) Number (if known): .… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181026 | OsteoBridge™ IDSF System | 2018 | 0 |
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 8.1 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K181026 (Merete GmbH, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K051965.
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 device is intended to be used in the management of segmental diaphyseal bone loss of the femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142451: OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142451
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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