510(k) · Cleared
ClearedOrlus Mini Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortholution Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Nov 25, 2008 as substantially equivalent to K050568 (Ortholution Co., Ltd., 2005) and 2 other predicates after a 60-day review. Its family tree reaches back 6 generations to 1990. 1 later device descends from it.
- Decided
- Nov 25, 2008
- Review
- 60 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K894844 (1990). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations backK973353 Bonding BaseStraumann USA · 1997
- 4 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 3 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 2 generations backK050568 Orlus Mini ScrewOrtholution Co., Ltd. · 2005
- 1 generation backK052968 Modification to: Orlus Mini ScrewOrtholution Co., Ltd. · 2006
- This deviceK082838 Orlus Mini ScrewOrtholution Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK102769 Neodent Implant for Orthodontic AnchorageJjgc Industria E Comercio DE Materiais Dentarios S · 2011
Most influential descendants
Showing 1 of 1 · See all- K102769Neodent Implant for Orthodontic AnchorageJjgc Industria E Comercio DE Materiais Dentarios S · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −5 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −4 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −3 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −2 | K050568 | Orlus Mini Screw | Ortholution Co., Ltd. | 2005 | — |
| −1 | K052968 | Modification to: Orlus Mini Screw | Ortholution Co., Ltd. | 2006 | — |
| 0 (this device) | K082838 | Orlus Mini Screw | Ortholution Co., Ltd. | 2008 | — |
| +1 | K102769 | Neodent Implant for Orthodontic Anchorage | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K050568 | Orlus Mini ScrewSummary page 1…Common Name - Small bone screw * Classification Name - Endosseous dental implant 3. Predicate Device · Ortholution Co., Ltd./ ORLUS Mini Screw/ K050568 and K052968 * Jeil Medical Corporation/Dual Top Anchor System Screws/K033767 4. Classifications names & Citations:… | 2005 |
| * | K052968 | Modification to: Orlus Mini ScrewSummary page 1…- Small bone screw * Classification Name - Endosseous dental implant 3. Predicate Device · Ortholution Co., Ltd./ ORLUS Mini Screw/ K050568 and K052968 * Jeil Medical Corporation/Dual Top Anchor System Screws/K033767 4. Classifications names & Citations: 21 CF… | 2006 |
| * | K033767 | Dual Top Anchor System ScrewsSummary page 1…ant 3. Predicate Device · Ortholution Co., Ltd./ ORLUS Mini Screw/ K050568 and K052968 * Jeil Medical Corporation/Dual Top Anchor System Screws/K033767 4. Classifications names & Citations: 21 CFR 872.3640, DZE, Endosseous dental implant, Class2 5. Description: O… | 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 |
|---|---|---|---|
| K102769 | Neodent Implant for Orthodontic Anchorage | 2011 | 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 18 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K102769 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2011) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K050568.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 ORLUS mini screw is intended for use as temporary anchor for orthodontic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082838: Orlus Mini Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082838
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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