510(k) · Cleared
ClearedMemfix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Straumann Co. · DZL Screw, Fixation, Intraosseous
Cleared on Jan 23, 1996 after a 60-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Jan 23, 1996
- Review
- 60 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK955369 MemfixThe Straumann Co. · 1996
- Descendant · cites it directly · 13 of its ownK960914 3I Osseous Fixation System (S)Implant Innovations, Inc. · 1996
- Descendant · cites it directly · 12 of its ownK011698 Straumann GBR SystemInstitut Straumann AG · 2001
- Descendant · 2 generations on · 8 of its ownK050669 Jeil Bone Fixation SystemJeil Medical Corporation · 2005
- Descendant · 2 generations on · 4 of its ownK063769 Alpha Bio Bone Fixation Screw SystemAlpha-Bio Tec, Ltd. · 2007
- Descendant · 3 generations on · 3 of its ownK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K9609143I Osseous Fixation System (S)Implant Innovations, Inc. · 1996 · cites it directly13descendants
- K011698Straumann GBR SystemInstitut Straumann AG · 2001 · cites it directly12descendants
- K050669Jeil Bone Fixation SystemJeil Medical Corporation · 2005 · 2 generations on8descendants
- K063769Alpha Bio Bone Fixation Screw SystemAlpha-Bio Tec, Ltd. · 2007 · 2 generations on4descendants
- K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955369 | Memfix | The Straumann Co. | 1996 | — |
| +1 | K960914 | 3I Osseous Fixation System (S) | Implant Innovations, Inc. | 1996 | — |
| +1 | K011698 | Straumann GBR System | Institut Straumann AG | 2001 | — |
| +2 | K050669 | Jeil Bone Fixation System | Jeil Medical Corporation | 2005 | — |
| +2 | K063769 | Alpha Bio Bone Fixation Screw System | Alpha-Bio Tec, Ltd. | 2007 | — |
| +3 | K141764 | Tristar Bone Graft Fixation System | Impladent, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 163 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, K960914 (Implant Innovations, Inc., 1996) has gone furthest, with 13 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/K955369 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955369: Memfix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955369
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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