510(k) · Cleared
ClearedStryker Leibinger Skeletal Anchoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger · DZE Implant, Endosseous, Root-Form
Cleared on Sep 30, 2004 as substantially equivalent to K033483 (KLS-Martin L.P., 2004) and 1 other predicate after a 105-day review. Its family tree reaches back 4 generations to 1996. 4 later devices descend from it.
- Decided
- Sep 30, 2004
- Review
- 105 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954385 (1996). 20 ancestors in all, the oldest K854886 (1986). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 3 generations backK981890 Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split PlatesSynthes (Usa) · 1998
- 2 generations backK993862 Modus Sagittal Split PlateThe Straumann Co. · 1999
- 1 generation backK022185 Universal CMF SystemStryker Instruments · 2002
- This deviceK041651 Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger · 2004
- Descendant · cites it directly · 1 of its ownK091051 Bollard Miniplate Skeletal Anchorage SystemTita-Link · 2009
- Descendant · 2 generations on · 0 of its ownK173623 Anchor plateBiomaterials Korea, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK063386 Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK051798 Osteomed Orthodontic Anchor Plating SystemOsteomed LP · 2006
Most influential descendants
Showing 4 of 4 · See all- K091051Bollard Miniplate Skeletal Anchorage SystemTita-Link · 2009 · cites it directly1descendant
- K173623Anchor plateBiomaterials Korea, Inc. · 2018 · 2 generations on0descendants
- K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc. · 2007 · cites it directly0descendants
- K051798Osteomed Orthodontic Anchor Plating SystemOsteomed LP · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −3 | K981890 | Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split Plates | Synthes (Usa) | 1998 | — |
| −2 | K993862 | Modus Sagittal Split Plate | The Straumann Co. | 1999 | — |
| −1 | K022185 | Universal CMF System | Stryker Instruments | 2002 | — |
| 0 (this device) | K041651 | Stryker Leibinger Skeletal Anchoring System | Stryker Leibinger | 2004 | — |
| +1 | K091051 | Bollard Miniplate Skeletal Anchorage System | Tita-Link | 2009 | — |
| +2 | K173623 | Anchor plate | Biomaterials Korea, Inc. | 2018 | — |
| +1 | K063386 | Lorenz Orthodontic Anchorage System | Walter Lorenz Surgical, Inc. | 2007 | — |
| +1 | K051798 | Osteomed Orthodontic Anchor Plating System | Osteomed LP | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K033483 | KLS-Martin Ortho Anchorage SystemSummary page 1…anchor in orthodontic procedures. Substantial Equivalency Information The Stryker® Leibinger Skeletal Anchoring System is substantially equivalent to legally marketed K033483 KLS-Martin Ortho Anchorage System, K022185 Universal CMF System. «, 5’ {( DEPARTMENT OF HEALTH & HUMAN SERVICES P… | 2004 |
| * | K022185 | Universal CMF SystemSummary page 1…tial Equivalency Information The Stryker® Leibinger Skeletal Anchoring System is substantially equivalent to legally marketed K033483 KLS-Martin Ortho Anchorage System, K022185 Universal CMF System. «, 5’ {( DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service L JC Food and Drug Ad… | 2002 |
What descends from it? (4)
3 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 8 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K091051 (Tita-Link, 2009) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K033483.
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 Stryker Leibinger Skeletal Anchoring System is a plating system intended to be placed in the mouth, for use as an anchor in orthodontic procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K041651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041651: Stryker Leibinger Skeletal Anchoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041651
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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