510(k) · Cleared
ClearedOsteomed SBF System (SBF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed Corp. · DZL Screw, Fixation, Intraosseous
Cleared on Aug 21, 1991 after a 112-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 22 later devices descend from it.
- Decided
- Aug 21, 1991
- Review
- 112 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 4 citing it directly.
- This deviceK911936 Osteomed SBF System (SBF)Osteomed Corp. · 1991
- Descendant · cites it directly · 15 of its ownK090522 Osteomed Hand Plate and Screw Fixation SystemOsteomed LP · 2009
- Descendant · 2 generations on · 7 of its ownK132769 Acumed Hand Plating SystemAcumed, LLC · 2014
- Descendant · 3 generations on · 6 of its ownK141383 Acumed Hand Fracture SystemAcumed, LLC · 2014
- Descendant · 4 generations on · 3 of its ownK161894 SurgTech Trauma SystemSurgtech, Inc. · 2017
- Descendant · 5 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K090522Osteomed Hand Plate and Screw Fixation SystemOsteomed LP · 2009 · cites it directly15descendants
- K132769Acumed Hand Plating SystemAcumed, LLC · 2014 · 2 generations on7descendants
- K141383Acumed Hand Fracture SystemAcumed, LLC · 2014 · 3 generations on6descendants
- K161894SurgTech Trauma SystemSurgtech, Inc. · 2017 · 4 generations on3descendants
- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911936 | Osteomed SBF System (SBF) | Osteomed Corp. | 1991 | — |
| +1 | K090522 | Osteomed Hand Plate and Screw Fixation System | Osteomed LP | 2009 | — |
| +2 | K132769 | Acumed Hand Plating System | Acumed, LLC | 2014 | — |
| +3 | K141383 | Acumed Hand Fracture System | Acumed, LLC | 2014 | — |
| +4 | K161894 | SurgTech Trauma System | Surgtech, Inc. | 2017 | — |
| +5 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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 DZL? 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 DZL device
- #1 K254286 Guided Bone Regeneration Systemscore 12.2 · 2 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? (22)
See all 224 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, K090522 (Osteomed LP, 2009) has gone furthest, with 15 descendants of its own.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZL
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZL
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZL
70in 2025
MAUDE reports naming product code DZL, 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 | 1 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 3 | 89 | 1 | 17 |
| 2011 | 2 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 236 |
| 2013 | 1 | — | 3 | 178 |
| 2014 | 2 | — | 0 | 106 |
| 2015 | 1 | — | 0 | 103 |
| 2016 | 1 | — | 0 | 34 |
| 2017 | 3 | 277 | 0 | 74 |
| 2018 | 0 | — | 0 | 57 |
| 2019 | 2 | — | 0 | 50 |
| 2020 | 1 | — | 0 | 85 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 162 |
| 2023 | 2 | — | 0 | 100 |
| 2024 | 2 | — | 0 | 106 |
| 2025 | 4 | 263 | 0 | 70 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K911936 · printed Nov 5, 2026
Cite this page
510(k) Report. “K911936: Osteomed SBF System (SBF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K911936
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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