510(k) · Cleared
ClearedMiltex Membrane Tack Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miltex, Inc. · DZL Screw, Fixation, Intraosseous
Cleared on Dec 29, 2009 as substantially equivalent to K973180 (Imtec Corp., 1997) and 1 other predicate after a 104-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Dec 29, 2009
- Review
- 104 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K952167 (1995). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK952167 Imz Bone Tack SystemInterpore Intl. · 1995
- 2 generations backK973180 Imtec Bone TacImtec Corp. · 1997
- 1 generation backK022790 The Autotac System Titanium TackBioHorizons Implant Systems, Inc. · 2002
- This deviceK092855 Miltex Membrane Tack KitMiltex, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK130682 Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger…Hager& Meisinger GmbH · 2013
- Descendant · 2 generations on · 1 of its ownK201561 Membrane Screws and Membrane TacksNeoss Limited · 2020
- Descendant · 3 generations on · 0 of its ownK243190 USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KG · 2025
- Descendant · 2 generations on · 0 of its ownK240321 MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH · 2024
Most influential descendants
Showing 4 of 4 · See all- K130682Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger Master-Pin-Control-Kit…Hager& Meisinger GmbH · 2013 · cites it directly3descendants
- K201561Membrane Screws and Membrane TacksNeoss Limited · 2020 · 2 generations on1descendant
- K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KG · 2025 · 3 generations on0descendants
- K240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952167 | Imz Bone Tack System | Interpore Intl. | 1995 | — |
| −2 | K973180 | Imtec Bone Tac | Imtec Corp. | 1997 | — |
| −1 | K022790 | The Autotac System Titanium Tack | BioHorizons Implant Systems, Inc. | 2002 | — |
| 0 (this device) | K092855 | Miltex Membrane Tack Kit | Miltex, Inc. | 2009 | — |
| +1 | K130682 | Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger… | Hager& Meisinger GmbH | 2013 | — |
| +2 | K201561 | Membrane Screws and Membrane Tacks | Neoss Limited | 2020 | — |
| +3 | K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 2025 | — |
| +2 | K240321 | MP Pin flat without thread (36BMP000020/MP20) | Hager& Meisinger GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K973180 | Imtec Bone TacSummary page 1…xate or stabilize guided tissue regeneration membranes to bone at the surgical site. Predicate Devices: 510(k) # Device Manufacturer K973 180 IM4TEC Bone Tac IMTEC Corporation K022790 AutoTac~m System Titanium Tack RioHorizons Impl… | 1997 |
| * | K022790 | The Autotac System Titanium TackSummary page 1…surgical site. Predicate Devices: 510(k) # Device Manufacturer K973 180 IM4TEC Bone Tac IMTEC Corporation K022790 AutoTac~m System Titanium Tack RioHorizons Implant Systems, Inc. Substantial Equivalence: Miltex® Membrane Tack Kit… | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130682 | Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger Master-Pin-Control-Kit… | 2013 | 3 |
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 14 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K130682 (Hager& Meisinger GmbH, 2013) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K973180.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Miltex® Membrane Tack Kit is intended to fixate or stabilize guided tissue regeneration membranes to bone at the surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092855 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092855: Miltex Membrane Tack Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092855
Report an extraction error
Are you the manufacturer?
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