510(k) · Cleared
ClearedSegmental Defect Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metagen, LLC · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on May 18, 1998 as substantially equivalent to K962553 (Biodynamic Technologies, Inc., 1996) after a 90-day review. Its family tree reaches back 1 generation to 1996. 5 later devices descend from it.
- Decided
- May 18, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962553 (1996). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK962553 EZ-Fix Midshaft Humeral Intramedullary Rod SystemBiodynamic Technologies, Inc. · 1996
- This deviceK980609 Segmental Defect Replacement SystemMetagen, LLC · 1998
- 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 · 2 generations on · 0 of its ownK101939 Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK984202 Howmedica Humeral Intercalary SystemHowmedica, Inc. · 1999
Most influential descendants
Showing 5 of 5 · 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 · 2 generations on0descendants
- K984202Howmedica Humeral Intercalary SystemHowmedica, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962553 | EZ-Fix Midshaft Humeral Intramedullary Rod System | Biodynamic Technologies, Inc. | 1996 | — |
| 0 (this device) | K980609 | Segmental Defect Replacement System | Metagen, LLC | 1998 | — |
| +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 |
| +2 | K101939 | Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation System | Merete Medical GmbH | 2010 | 1 |
| +1 | K984202 | Howmedica Humeral Intercalary System | Howmedica, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K962553 | EZ-Fix Midshaft Humeral Intramedullary Rod SystemSummary page 2…m. Spacer. System. Intermedics Wright Medical Biodynamics Howmedica Orthopedics, Inc. Technology Technologies, Inc. (K954559) (Sulzer Orthopedics) (K933281) Mayo Clinic (K962553) (K960626) Intended Use Reconstruction of the humeral diaphysis with an extensive destructive bone lesion due to metastatic dis… | 1996 |
| † | K954559 | Howmedicca Modular Proximal Humerus Replacement System | 1996 |
| † | K960626 | Modular Oncology System Technology (Most) | 1996 |
| † | K933281 | S.O.S. Proximal Femur | 1994 |
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 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 | — |
What is it indicated for?
The Segmental Defect Replacement System, when used with bone cement, is intended for reconstruction of the humeral diaphysis with an extensive destructive bone lesion due to metastatic disease, myeloma, or lymphoma, that places the humerus at risk for pathologic fracture.
The Segmental Defect Replacement System, when used with bone cement, is indicated for pathologic fractures or impending pathologic fractures of the diaphysis of the humerus secondary to metastatic bone disease and hematologic malignancies.
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/K980609 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980609: Segmental Defect Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980609
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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