510(k) · Cleared
ClearedOsteomed Orthodontic Anchor Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · DZE Implant, Endosseous, Root-Form
Cleared on Apr 7, 2006 as substantially equivalent to K040891 (KLS-Martin L.P., 2004) and 1 other predicate after a 276-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Apr 7, 2006
- Review
- 276 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). No later device cites it as a predicate yet.
- 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 deviceK051798 Osteomed Orthodontic Anchor Plating SystemOsteomed LP · 2006
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) | 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 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 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 1…device is based on similarities in intended use, material, design and operational principle to the KILS-Martin Ortho Anchorage System (K040891) and the Stryker Leibinger Skeletal Anchoring System (K041 651). Due to the similarity of materials and design t… | 2004 |
| * | K041651 | Stryker Leibinger Skeletal Anchoring SystemSummary page 1…design and operational principle to the KILS-Martin Ortho Anchorage System (K040891) and the Stryker Leibinger Skeletal Anchoring System (K041 651). Due to the similarity of materials and design to the predicate devices, OsteoMed believes tha… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 23 ancestors have a recall of any class.
- 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.
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?
Intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. Plates, screws, and pilot drills are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051798 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051798: Osteomed Orthodontic Anchor Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051798
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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