510(k) · Cleared
ClearedOrthocaps Twinaligner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Caps GmbH · NXC Aligner, Sequential
Cleared on Sep 28, 2018 as substantially equivalent to K081960 (Align Technology, 2008) and 1 other predicate after a 242-day review. Its family tree reaches back 5 generations to 1978. 15 later devices descend from it.
- Decided
- Sep 28, 2018
- Review
- 242 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K780619 (1978). 8 ancestors in all. 15 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 4 generations backK981095 Align SystemAlign Technology · 1998
- 3 generations backK071970 Clear Image AlignerSpecialty Appliance Works, Inc. · 2007
- 2 generations backK082556 ClearcorrectClearcorrect, Inc. · 2009
- 1 generation backK113618 Clearcorrect SystemClearcorrect, Inc. · 2012
- This deviceK180241 Orthocaps TwinalignerOrtho Caps GmbH · 2018
- Descendant · cites it directly · 8 of its ownK192596 ULab Systems Dental Aligner KitUlab Systems, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK212680 LuxCreo Clear Aligner SystemLuxCreo, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK191838 Clearform AlignersMotor City Lab Works · 2020
- Descendant · 2 generations on · 2 of its ownK202792 BRIUS Clear AlignersBrius Technologies, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK232653 Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio…Blue Sky Bio, LLC · 2024
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K192596ULab Systems Dental Aligner KitUlab Systems, Inc. · 2020 · cites it directly8descendants
- K212680LuxCreo Clear Aligner SystemLuxCreo, Inc. · 2022 · 2 generations on3descendants
- K191838Clearform AlignersMotor City Lab Works · 2020 · cites it directly3descendants
- K202792BRIUS Clear AlignersBrius Technologies, Inc. · 2021 · 2 generations on2descendants
- K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −4 | K981095 | Align System | Align Technology | 1998 | — |
| −3 | K071970 | Clear Image Aligner | Specialty Appliance Works, Inc. | 2007 | — |
| −2 | K082556 | Clearcorrect | Clearcorrect, Inc. | 2009 | — |
| −1 | K113618 | Clearcorrect System | Clearcorrect, Inc. | 2012 | — |
| 0 (this device) | K180241 | Orthocaps Twinaligner | Ortho Caps GmbH | 2018 | — |
| +1 | K192596 | ULab Systems Dental Aligner Kit | Ulab Systems, Inc. | 2020 | — |
| +2 | K212680 | LuxCreo Clear Aligner System | LuxCreo, Inc. | 2022 | — |
| +1 | K191838 | Clearform Aligners | Motor City Lab Works | 2020 | — |
| +2 | K202792 | BRIUS Clear Aligners | Brius Technologies, Inc. | 2021 | — |
| +2 | K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | Blue Sky Bio, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 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 NXC? 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 NXC device
- #1 K220287 Invisalign Systemscore 20.3 · 5 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 |
|---|---|---|---|
| * | K081960 | Invisalign SystemSummary page 4…Device Classification: Class II Product Code: NXC 5. Predicate Devices: Invisalign® System Primary Predicate K081960 Align Technology, Inc ClearCorrect System Reference Predicate K113618 ClearCorrect LLC 3Sh… | 2008 |
| * | K113618 | Clearcorrect SystemSummary page 4…edicate Devices: Invisalign® System Primary Predicate K081960 Align Technology, Inc ClearCorrect System Reference Predicate K113618 ClearCorrect LLC 3Shape Ortho System TM Reference Predicate K152086 3Shape A/S 6. Device Descript… | 2012 |
| † | K152086 | 3Shape Ortho System | 2016 |
What descends from it? (15)
See all 154 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 40 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K192596 (Ulab Systems, Inc., 2020) has gone furthest, with 8 descendants of its own.
- 8 other devices also cite its predicate K081960.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NXC
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NXC
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NXC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NXC
4,523in 2025
MAUDE reports naming product code NXC, 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 | 1 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 59 |
| 2012 | 2 | — | 0 | 24 |
| 2013 | 4 | 124 | 0 | 28 |
| 2014 | 0 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 43 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 3 | 85 | 0 | 47 |
| 2018 | 11 | 116 | 0 | 67 |
| 2019 | 16 | 182 | 0 | 127 |
| 2020 | 16 | 230 | 0 | 175 |
| 2021 | 20 | 97 | 0 | 929 |
| 2022 | 19 | 137 | 0 | 605 |
| 2023 | 13 | 152 | 0 | 433 |
| 2024 | 14 | 105 | 2 | 8,991 |
| 2025 | 11 | 61 | 0 | 4,523 |
| 2026 | 5 | 127 | 0 | — |
What is it indicated for?
The Orthocaps TwinAligner® System is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180241: Orthocaps Twinaligner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180241
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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