510(k) · Cleared
ClearedKLS-Martin Ortho Anchorage System
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 Jan 15, 2004 as substantially equivalent to K971297 (KLS-Martin L.P., 1997) and 1 other predicate after a 72-day review. Its family tree reaches back 2 generations to 1993. 18 later devices descend from it.
- Decided
- Jan 15, 2004
- Review
- 72 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. 18 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 deviceK033483 KLS-Martin Ortho Anchorage SystemKLS-Martin L.P. · 2004
- Descendant · cites it directly · 6 of its ownK061397 Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM…Ace Surgical Supply Co., Inc. · 2006
- Descendant · 2 generations on · 5 of its ownK080074 Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc. · 2008
- Descendant · cites it directly · 4 of its ownK042573 KLS Martin Drill-Free MMF ScrewKLS-Martin L.P. · 2004
- Descendant · cites it directly · 4 of its ownK041651 Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger · 2004
- Descendant · 2 generations on · 3 of its ownK083432 Drill Free MMF ScrewKLS Martin L.P. · 2009
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K061397Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model…Ace Surgical Supply Co., Inc. · 2006 · cites it directly6descendants
- K080074Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc. · 2008 · 2 generations on5descendants
- K042573KLS Martin Drill-Free MMF ScrewKLS-Martin L.P. · 2004 · cites it directly4descendants
- K041651Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger · 2004 · cites it directly4descendants
- K083432Drill Free MMF ScrewKLS Martin L.P. · 2009 · 2 generations on3descendants
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) | K033483 | KLS-Martin Ortho Anchorage System | KLS-Martin L.P. | 2004 | — |
| +1 | K061397 | Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model… | Ace Surgical Supply Co., Inc. | 2006 | — |
| +2 | K080074 | Ace Surigical Tru-Fix Implant System, Model 454-180X-XX | Ace Surgical Supply Co., Inc. | 2008 | — |
| +1 | K042573 | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | 2004 | — |
| +1 | K041651 | Stryker Leibinger Skeletal Anchoring System | Stryker Leibinger | 2004 | — |
| +2 | K083432 | Drill Free MMF Screw | KLS Martin L.P. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K971297 | Centre-Drive Drill-Free ScrewSummary page 1…Endosseous Implant (CFR 872.3640) Regulatory Class: Class IIl Predicate Devices: Centre-Drive Drill Free Screw (K971 297) Nobel Biocare Onpiant Orthodontic System (K980460) Device Descrip… | 1997 |
| * | K980460 | Onplant Orthodontic SystemSummary page 1…-Drive Drill Free Screw (K971 297) Nobel Biocare Onpiant Orthodontic System (K980460) Device Description: The KLS-Martin Ortho Anchorage System consists of a titaniu… | 1998 |
What descends from it? (18)
See all 185 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061397 | Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model… | 2006 | 6 |
| K042573 | KLS Martin Drill-Free MMF Screw | 2004 | 4 |
| K041651 | Stryker Leibinger Skeletal Anchoring System | 2004 | 4 |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | 2024 | 1 |
| K063473 | Synthes Orthodontic Bone Anchor System | 2007 | 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 5.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K061397 (Ace Surgical Supply Co., Inc., 2006) has gone furthest, with 6 descendants of its own.
- 8 other devices also cite its predicate K971297.
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 are screws 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/K033483 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033483: KLS-Martin Ortho Anchorage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033483
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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