510(k) · Cleared
ClearedSpine Planning (2.0), Elements Spine Planning, Elements Planning Spine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · OLO Orthopedic Stereotaxic Instrument
Cleared on Aug 2, 2023 as substantially equivalent to K212245 (Brainlab AG, 2022) after a 250-day review. Its family tree reaches back 8 generations to 1999. 3 of the 20 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Aug 2, 2023
- Review
- 250 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K983831 (1999). 18 ancestors in all, the oldest K981508 (1998). 1 later device descends from it, 1 citing it directly. 3 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 7 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 6 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 5 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 4 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 3 generations backK083310 Spine & Trauma IctBrainlab AG · 2009
- 2 generations backK183605 Spine & Trauma NavigationBrainlab AG · 2019 · Recalled
- 1 generation backK212245 Spine and Trauma Navigation System, Spine & Trauma 3D Navigation…Brainlab AG · 2022
- This deviceK223553 Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG · 2023
- Descendant · cites it directly · 0 of its ownK262257 Spine Planning (3.0); Spine & Trauma Navigation; Alignment System…Brainlab SE · 2026
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −7 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −6 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −5 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −4 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −3 | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
| −2 | K183605 | Spine & Trauma Navigation | Brainlab AG | 2019 | 3 |
| −1 | K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument… | Brainlab AG | 2022 | — |
| 0 (this device) | K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Brainlab AG | 2023 | — |
| +1 | K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | Brainlab SE | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
3 devices in this family have a Class I recall. 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 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? (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 |
|---|---|---|---|
| * | K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Summary page 4…OLO Regulation Number 882.4560 Regulatory Class II Panel Orthopedic Predicate Device K212245 Spine and Trauma Navigation System, Spine & Trauma 3D Navigati… | 2022 |
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 |
|---|---|---|---|
| K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | 2026 | 0 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 3 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 4 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K070106VV Fluoro 3DBrainlab AG · 2007 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- 8 of the 18 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K262257 (Brainlab SE, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K212245.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
Spine Planning is intended for pre- and intraoperative planning of open and minimally invasive spinal procedures. It displays digital patient images (CT, Cone Beam CT, MR, X-ray) and allows measurement and planning of spinal implants like screws and rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223553 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223553: Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223553
Report an extraction error
Are you the manufacturer?
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