510(k) · Cleared
ClearedMembrane Screws and Membrane Tacks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoss Limited · DZL Screw, Fixation, Intraosseous
Cleared on Oct 5, 2020 as substantially equivalent to K130682 (Hager& Meisinger GmbH, 2013) and 1 other predicate after a 117-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Oct 5, 2020
- Review
- 117 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K952167 (1995). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK952167 Imz Bone Tack SystemInterpore Intl. · 1995
- 4 generations backK973180 Imtec Bone TacImtec Corp. · 1997
- 3 generations backK022790 The Autotac System Titanium TackBioHorizons Implant Systems, Inc. · 2002
- 2 generations backK092855 Miltex Membrane Tack KitMiltex, Inc. · 2009
- 1 generation backK130682 Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger…Hager& Meisinger GmbH · 2013
- This deviceK201561 Membrane Screws and Membrane TacksNeoss Limited · 2020
- Descendant · cites it directly · 0 of its ownK243190 USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KG · 2025
Most influential descendants
Showing 1 of 1 · See all- K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KG · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952167 | Imz Bone Tack System | Interpore Intl. | 1995 | — |
| −4 | K973180 | Imtec Bone Tac | Imtec Corp. | 1997 | — |
| −3 | K022790 | The Autotac System Titanium Tack | BioHorizons Implant Systems, Inc. | 2002 | — |
| −2 | K092855 | Miltex Membrane Tack Kit | Miltex, Inc. | 2009 | — |
| −1 | K130682 | Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger… | Hager& Meisinger GmbH | 2013 | — |
| 0 (this device) | K201561 | Membrane Screws and Membrane Tacks | Neoss Limited | 2020 | — |
| +1 | K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K130682 | Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger Master-Pin-Control-Kit…Summary page 4…Intraosseous Tacks, Screws Regulatory Class: II Regulation: 872.4880 Product Code: DZL Predicate Device(s): Meisinger Tacs, Hager and Meisinger GmbH K130682 Pro-fix Membrane Fixation Screws, Osteogenics K093719 Device Description: Membrane Tacks and Membrane Screws are regenerative m… | 2013 |
| * | K093719 | Pro-Fix Precision Fixation System Model PFM#, PFB#, PFT#Summary page 4…: II Regulation: 872.4880 Product Code: DZL Predicate Device(s): Meisinger Tacs, Hager and Meisinger GmbH K130682 Pro-fix Membrane Fixation Screws, Osteogenics K093719 Device Description: Membrane Tacks and Membrane Screws are regenerative membrane fastening devices available in 3mm length. The… | 2010 |
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 |
|---|---|---|---|
| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | 2025 | 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?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K243190 (Ustomed Instrumente Ulrich Storz GmbH & Co. KG, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130682.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Membrane Tacks and Membrane Screws are intended for fastening membranes during bone regenerative treatment. These membrane fastening means are in direct body contact, intended for temporary use only. Membrane fastening means are submerged and clinically implanted more than 30 days with an expected duration of implantation of three to nine months or until bone regeneration is complete taking into account which membrane and bone grafting materials are being used.
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/K201561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201561: Membrane Screws and Membrane Tacks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201561
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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