510(k) · Cleared
ClearedKLS Martin Ortho Anchorage System (Plates)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · DZE Implant, Endosseous, Root-Form
Cleared on May 28, 2004 as substantially equivalent to K944565 (KLS-Martin L.P., 1994) and 1 other predicate after a 53-day review. Its family tree reaches back 2 generations to 1993. 7 later devices descend from it.
- Decided
- May 28, 2004
- Review
- 53 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K925771 (1993). 8 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK925771 Branemark System Titanium Cover ScrewsNobelpharma USA, Inc. · 1993
- 1 generation backK980460 Onplant Orthodontic SystemNobel Biocare Uas, Inc. · 1998
- This deviceK040891 KLS Martin Ortho Anchorage System (Plates)KLS-Martin L.P. · 2004
- Descendant · cites it directly · 1 of its ownK241314 KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024
- Descendant · cites it directly · 1 of its ownK091051 Bollard Miniplate Skeletal Anchorage SystemTita-Link · 2009
- Descendant · 2 generations on · 0 of its ownK260137 KLS Martin IPS Oral-Max Implants - MR Conditional; Individual…KLS-Martin L.P. · 2026
- Descendant · 2 generations on · 0 of its ownK173623 Anchor plateBiomaterials Korea, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK063473 Synthes Orthodontic Bone Anchor SystemSynthes (Usa) · 2007
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024 · cites it directly1descendant
- K091051Bollard Miniplate Skeletal Anchorage SystemTita-Link · 2009 · cites it directly1descendant
- K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P. · 2026 · 2 generations on0descendants
- K173623Anchor plateBiomaterials Korea, Inc. · 2018 · 2 generations on0descendants
- K063473Synthes Orthodontic Bone Anchor SystemSynthes (Usa) · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925771 | Branemark System Titanium Cover Screws | Nobelpharma USA, Inc. | 1993 | — |
| −1 | K980460 | Onplant Orthodontic System | Nobel Biocare Uas, Inc. | 1998 | — |
| 0 (this device) | K040891 | KLS Martin Ortho Anchorage System (Plates) | KLS-Martin L.P. | 2004 | — |
| +1 | K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | 2024 | — |
| +1 | K091051 | Bollard Miniplate Skeletal Anchorage System | Tita-Link | 2009 | — |
| +2 | K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient… | KLS-Martin L.P. | 2026 | — |
| +2 | K173623 | Anchor plate | Biomaterials Korea, Inc. | 2018 | — |
| +1 | K063473 | Synthes Orthodontic Bone Anchor System | Synthes (Usa) | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM)Summary page 1…872.3640) Regulatory Class: Class III Predicate Devices: KLS-Martin Micro Osteosynthesis System (1.5mm) (K944565) Nobel Biocare Onplant Orthodontic System (K980460) Device De… | 1994 |
| * | K980460 | Onplant Orthodontic SystemSummary page 1…is System (1.5mm) (K944565) Nobel Biocare Onplant Orthodontic System (K980460) Device Description: The KLS-Martin Ortho Anchorage System includes several… | 1998 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | 2024 | 1 |
| K091051 | Bollard Miniplate Skeletal Anchorage System | 2009 | 1 |
| K063473 | Synthes Orthodontic Bone Anchor System | 2007 | 0 |
| K063386 | Lorenz Orthodontic Anchorage System | 2007 | 0 |
| K051798 | Osteomed Orthodontic Anchor Plating System | 2006 | 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 11 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K241314 (KLS-Martin L.P., 2024) has gone furthest, with 1 descendant of its own.
- 14 other devices also cite its predicate K944565.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 KLS-Martin Ortho Anchorage System (Plates) are implants intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures in patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040891: KLS Martin Ortho Anchorage System (Plates).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040891
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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