510(k) · Cleared
ClearedBollard Miniplate Skeletal Anchorage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tita-Link · DZE Implant, Endosseous, Root-Form
Cleared on Dec 8, 2009 as substantially equivalent to K040891 (KLS-Martin L.P., 2004) and 1 other predicate after a 239-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Dec 8, 2009
- Review
- 239 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954385 (1996). 23 ancestors in all, the oldest K854886 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 4 generations backK981890 Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split PlatesSynthes (Usa) · 1998
- 3 generations backK993862 Modus Sagittal Split PlateThe Straumann Co. · 1999
- 2 generations backK022185 Universal CMF SystemStryker Instruments · 2002
- 1 generation backK041651 Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger · 2004
- This deviceK091051 Bollard Miniplate Skeletal Anchorage SystemTita-Link · 2009
- Descendant · cites it directly · 0 of its ownK173623 Anchor plateBiomaterials Korea, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173623Anchor plateBiomaterials Korea, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −4 | K981890 | Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split Plates | Synthes (Usa) | 1998 | — |
| −3 | K993862 | Modus Sagittal Split Plate | The Straumann Co. | 1999 | — |
| −2 | K022185 | Universal CMF System | Stryker Instruments | 2002 | — |
| −1 | K041651 | Stryker Leibinger Skeletal Anchoring System | Stryker Leibinger | 2004 | — |
| 0 (this device) | K091051 | Bollard Miniplate Skeletal Anchorage System | Tita-Link | 2009 | — |
| +1 | K173623 | Anchor plate | Biomaterials Korea, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 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 |
|---|---|---|---|
| * | K040891 | KLS Martin Ortho Anchorage System (Plates)Summary page 2…lass 2 device under the following product code / regulation: o DZE, 21 CFR 872.3640 Predicate Device [21 CFR 807.92(a)(3)j KLS Martin - Ortho Anchorage System - K040891 Stryker Leibinger Skeletal Anchoring System - K04 1651 Indications for Use 121 CFR 807.92(a)(5)j The subject devices a… | 2004 |
| * | K041651 | Stryker Leibinger Skeletal Anchoring SystemSummary page 2…ation: o DZE, 21 CFR 872.3640 Predicate Device [21 CFR 807.92(a)(3)j KLS Martin - Ortho Anchorage System - K040891 Stryker Leibinger Skeletal Anchoring System - K04 1651 Indications for Use 121 CFR 807.92(a)(5)j The subject devices are intended to be placed in the mouth for use as an anc… | 2004 |
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 |
|---|---|---|---|
| K173623 | Anchor plate | 2018 | 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 13 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K173623 (Biomaterials Korea, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K040891.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The subject devices are intended to be placed in the mouth for use as an anchor in orthodontic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091051: Bollard Miniplate Skeletal Anchorage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091051
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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