510(k) · Cleared
ClearedPro-Fix Precision Fixation System Model PFM#, PFB#, PFT#
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteogenics Biomedical, Inc. · DZL Screw, Fixation, Intraosseous
Cleared on Mar 1, 2010 after an 89-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Mar 1, 2010
- Review
- 89 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK093719 Pro-Fix Precision Fixation System Model PFM#, PFB#, PFT#Osteogenics Biomedical, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK201561 Membrane Screws and Membrane TacksNeoss Limited · 2020
- Descendant · cites it directly · 0 of its ownK250123 Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)Hager& Meisinger GmbH · 2025
- Descendant · 2 generations on · 0 of its ownK243190 USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KG · 2025
- Descendant · cites it directly · 0 of its ownK171831 Intra-Lock Bone Fixation SystemIntra-Lock International, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK161857 Salvin Tenting Screw SystemSalvin Dental Specialties · 2017
Most influential descendants
Showing 5 of 5 · See all- K201561Membrane Screws and Membrane TacksNeoss Limited · 2020 · cites it directly1descendant
- K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)Hager& Meisinger GmbH · 2025 · cites it directly0descendants
- K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KG · 2025 · 2 generations on0descendants
- K171831Intra-Lock Bone Fixation SystemIntra-Lock International, Inc. · 2017 · cites it directly0descendants
- K161857Salvin Tenting Screw SystemSalvin Dental Specialties · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093719 | Pro-Fix Precision Fixation System Model PFM#, PFB#, PFT# | Osteogenics Biomedical, Inc. | 2010 | — |
| +1 | K201561 | Membrane Screws and Membrane Tacks | Neoss Limited | 2020 | — |
| +1 | K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH | 2025 | — |
| +2 | K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 2025 | — |
| +1 | K171831 | Intra-Lock Bone Fixation System | Intra-Lock International, Inc. | 2017 | — |
| +1 | K161857 | Salvin Tenting Screw System | Salvin Dental Specialties | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
4 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, K201561 (Neoss Limited, 2020) has gone furthest, with 1 descendant 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. 2010, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Pro-FixTM Precision Fixation System is used to stabilize,
fixate and/or support bone grafts, bone filling materials and/or barrier membranes
used for regeneration of bone in the oral cavity.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K093719 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093719: Pro-Fix Precision Fixation System Model PFM#, PFB#, PFT#.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093719
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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