510(k) · Cleared
ClearedIplan! Digital Templating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · HAW Neurological Stereotaxic Instrument
Cleared on May 17, 2005 as substantially equivalent to K020631 (Brainlab AG, 2002) after a 239-day review. Its family tree reaches back 2 generations to 1999. 7 later devices descend from it.
- Decided
- May 17, 2005
- Review
- 239 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983410 (1999). 5 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK983410 @ TargetBrainlab AG · 1999
- 1 generation backK020631 IPLANBrainlab AG · 2002
- This deviceK042543 Iplan! Digital TemplatingBrainlab AG · 2005
- Descendant · cites it directly · 6 of its ownK080608 Digital LightboxBrainlab AG · 2008
- Descendant · 2 generations on · 5 of its ownK093117 Digital LightboxBrainlab AG · 2009 · Recalled
- Descendant · 3 generations on · 4 of its ownK153653 DICOM ViewerBrainlab AG · 2016
- Descendant · 4 generations on · 3 of its ownK191014 Elements ViewerBrainlab AG · 2020
- Descendant · 5 generations on · 1 of its ownK232759 Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout…Brainlab AG · 2024 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K080608Digital LightboxBrainlab AG · 2008 · cites it directly6descendants
- K093117Digital LightboxBrainlab AG · 2009 · 2 generations on5descendants
- K153653DICOM ViewerBrainlab AG · 2016 · 3 generations on4descendants
- K191014Elements ViewerBrainlab AG · 2020 · 4 generations on3descendants
- K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983410 | @ Target | Brainlab AG | 1999 | — |
| −1 | K020631 | IPLAN | Brainlab AG | 2002 | — |
| 0 (this device) | K042543 | Iplan! Digital Templating | Brainlab AG | 2005 | — |
| +1 | K080608 | Digital Lightbox | Brainlab AG | 2008 | — |
| +2 | K093117 | Digital Lightbox | Brainlab AG | 2009 | 2 |
| +3 | K153653 | DICOM Viewer | Brainlab AG | 2016 | — |
| +4 | K191014 | Elements Viewer | Brainlab AG | 2020 | — |
| +5 | K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements… | Brainlab AG | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K020631 | IPLANSummary page 1…2005 Device Name: Trade name: iPlan® Hip Templating Common/Classification Name: Planning System Predicate Device: iPlan!® 2 (K020631) Device Classification Name: Stereotaxic instrument Regulatory Class: Class II Intended Use: The iPlan Hip Templating system i… | 2002 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080608 | Digital Lightbox | 2008 | 6 |
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 6 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K080608 (Brainlab AG, 2008) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K020631.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The iPlan Hip Templating system is indicated for the preoperative planning of orthopedic treatments. It is specially developed for the preparation and display of anatomical patient data that has been acquired using x-ray, CT or MR equipment.
iPlan Hip Templating creates treatment plans in conjunction with 2D / 3D implant models. Implant models are provided by a separate database-Both 2D and 3D planning are supported, depending on the anatomical information available.
The treatment plan can either be saved or printed as required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042543: Iplan! Digital Templating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042543
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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