510(k) · Cleared
ClearedThe Autotac System Titanium Tack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BioHorizons Implant Systems, Inc. · DZL Screw, Fixation, Intraosseous
Cleared on Aug 28, 2002 as substantially equivalent to K993493 (BioHorizons Implant Systems, Inc., 2000) and 3 other predicates after a 6-day review. Its family tree reaches back 2 generations to 1995. 6 later devices descend from it.
- Decided
- Aug 28, 2002
- Review
- 6 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K952167 (1995). 5 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK952167 Imz Bone Tack SystemInterpore Intl. · 1995
- 1 generation backK973180 Imtec Bone TacImtec Corp. · 1997
- This deviceK022790 The Autotac System Titanium TackBioHorizons Implant Systems, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK092855 Miltex Membrane Tack KitMiltex, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK130682 Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger…Hager& Meisinger GmbH · 2013
- Descendant · 3 generations on · 1 of its ownK201561 Membrane Screws and Membrane TacksNeoss Limited · 2020
- Descendant · 4 generations on · 0 of its ownK243190 USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KG · 2025
- Descendant · 3 generations on · 0 of its ownK240321 MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K092855Miltex Membrane Tack KitMiltex, Inc. · 2009 · cites it directly4descendants
- K130682Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger Master-Pin-Control-Kit…Hager& Meisinger GmbH · 2013 · 2 generations on3descendants
- K201561Membrane Screws and Membrane TacksNeoss Limited · 2020 · 3 generations on1descendant
- K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KG · 2025 · 4 generations on0descendants
- K240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952167 | Imz Bone Tack System | Interpore Intl. | 1995 | — |
| −1 | K973180 | Imtec Bone Tac | Imtec Corp. | 1997 | — |
| 0 (this device) | K022790 | The Autotac System Titanium Tack | BioHorizons Implant Systems, Inc. | 2002 | — |
| +1 | K092855 | Miltex Membrane Tack Kit | Miltex, Inc. | 2009 | — |
| +2 | K130682 | Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger… | Hager& Meisinger GmbH | 2013 | — |
| +3 | K201561 | Membrane Screws and Membrane Tacks | Neoss Limited | 2020 | — |
| +4 | K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 2025 | — |
| +3 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K993493 | The Autotac SystemSummary page 1…y BioHorizons Implant Systems Inc. Authorization to legally market the predicate BioHorizons AUTOTAC System has been documented under the following 51O(k) numbers: K993493, KO11675 The predicate devices for the titanium tack are the IMZ Bone Tack System manufactured and distributed by INTERP… | 2000 |
| * | K011675 | The Autotac System | 2001 |
| * | K952167 | Imz Bone Tack SystemSummary page 1…. and IMTEC Bone Tac manufactured and distributed by IMTEC Corporation. Authorization to market the IMZ Bone Tack System has been documented under 51O(k) numbers K952167. Authorization to market the IMTEC Bone Tac has been documented under 510(k) numbers K973180. Device Description The p… | 1995 |
| * | K973180 | Imtec Bone TacSummary page 1…he IMZ Bone Tack System has been documented under 51O(k) numbers K952167. Authorization to market the IMTEC Bone Tac has been documented under 510(k) numbers K973180. Device Description The proposed membrane fixation tack is fabricated from titanium alloy as specified in ASTM F136 - Specif… | 1997 |
What descends from it? (6)
2 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K092855 (Miltex, Inc., 2009) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K993493.
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 AutoTac SystemTM Titanium Tack is intended to fixate and stabilize bioresorbable and non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in other clinical situations that require membrane use or fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022790: The Autotac System Titanium Tack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022790
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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