510(k) · Cleared
ClearedLeadfix Bioresorbable Membrance Pin System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biovision GmbH · DZL Screw, Fixation, Intraosseous
Cleared on Jan 30, 1998 as substantially equivalent to K960945 (Interpore Intl., 1996) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Jan 30, 1998
- Review
- 70 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955369 (1996). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K982951Imtec BiopinImtec Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955369 | Memfix | The Straumann Co. | 1996 | — |
| 0 (this device) | K974392 | Leadfix Bioresorbable Membrance Pin System | Biovision GmbH | 1998 | — |
| +1 | K982951 | Imtec Biopin | Imtec Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 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? (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 |
|---|---|---|---|
| * | K960945 | Imz Membrane Tack SystemSummary page 1…brane fixation pin Classification Name: Screw, fixation, intraosseous per Dental Products Panel 21 CFR section 872.4880 3. Predicate Devices IMZ Membrane Tack System (K960945) MemFix™ System (K955369) 4. Device Description The LEADfix Bioresorbable Membrane Pin System consists of components and instru… | 1996 |
| * | K955369 | MemfixSummary page 1…fication Name: Screw, fixation, intraosseous per Dental Products Panel 21 CFR section 872.4880 3. Predicate Devices IMZ Membrane Tack System (K960945) MemFix™ System (K955369) 4. Device Description The LEADfix Bioresorbable Membrane Pin System consists of components and instruments designed to fixate… | 1996 |
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 |
|---|---|---|---|
| K982951 | Imtec Biopin | 1999 | 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?
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 | — |
What is it indicated for?
The LEADfix Bioresorbable Membrane Pin System is designed to fixate
and stabilize resorbable barrier membranes during the healing process
by providing an attachment mechanism for the membrane to resident and
adjacent bone at the surgical site. The LEADfix membrane pin is
indicated for use with absorbable guided tissue and guided bone
regeneration membranes.
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/K974392 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974392: Leadfix Bioresorbable Membrance Pin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974392
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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