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 Jun 1, 2005 as substantially equivalent to K031936 (Osteomed LP, 2004) after an 89-day review. Its family tree reaches back 4 generations to 1990. 5 later devices descend from it.
- Decided
- Jun 1, 2005
- Review
- 89 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K894844 (1990). 15 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 3 generations backK973353 Bonding BaseStraumann USA · 1997
- 2 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 1 generation backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- This deviceK050568 Orlus Mini ScrewOrtholution Co., Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK052968 Modification to: Orlus Mini ScrewOrtholution Co., Ltd. · 2006
- Descendant · cites it directly · 1 of its ownK082838 Orlus Mini ScrewOrtholution Co., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK062367 Miniscrews Anchoring System, M.a.S.Micerium S.P.A. · 2006
- Descendant · 2 generations on · 0 of its ownK102769 Neodent Implant for Orthodontic AnchorageJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- Descendant · cites it directly · 0 of its ownK072917 JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008
Most influential descendants
Showing 5 of 5 · See all- K052968Modification to: Orlus Mini ScrewOrtholution Co., Ltd. · 2006 · cites it directly2descendants
- K082838Orlus Mini ScrewOrtholution Co., Ltd. · 2008 · cites it directly1descendant
- K062367Miniscrews Anchoring System, M.a.S.Micerium S.P.A. · 2006 · cites it directly1descendant
- K102769Neodent Implant for Orthodontic AnchorageJjgc Industria E Comercio DE Materiais Dentarios S · 2011 · 2 generations on0descendants
- K072917JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −3 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −2 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −1 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| 0 (this device) | K050568 | Orlus Mini Screw | Ortholution Co., Ltd. | 2005 | — |
| +1 | K052968 | Modification to: Orlus Mini Screw | Ortholution Co., Ltd. | 2006 | — |
| +1 | K082838 | Orlus Mini Screw | Ortholution Co., Ltd. | 2008 | — |
| +1 | K062367 | Miniscrews Anchoring System, M.a.S. | Micerium S.P.A. | 2006 | — |
| +2 | K102769 | Neodent Implant for Orthodontic Anchorage | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
| +1 | K072917 | JJG Evolution Orthodontic Implant System | Odontit S.A. | 2008 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K031936 | Osteomed Orthodontic Screw SystemSummary page 1…screw Classification Name - Endosseous dental implant 3. Predicate Device: Osterned Orthodontic Screw System, OsteoMed LP K031936 Dual Top Anchor System Screws. Jeil Medical Corporation, KOS3767 4 Classifications Names & Citations… | 2004 |
| * | — | Dual Top Anchor System Screws Named without a submission number |
What descends from it? (5)
4 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 15 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K052968 (Ortholution Co., Ltd., 2006) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K031936.
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 Orlus Mini Screw is intended for use as a temporary anchor for orthodontic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050568: 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/K050568
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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