510(k) · Cleared
ClearedIntraOp Alignment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on May 22, 2024 as substantially equivalent to K170800 (Nu Vasive, Incorporated, 2017) and 1 other predicate after a 118-day review. Its family tree reaches back 14 generations to 1984. 1 later device descends from it.
- Decided
- May 22, 2024
- Review
- 118 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K842956 (1984). 93 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 10 generations between
- 3 generations backK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- 2 generations backK162647 NuVasive NuvaLine Mobile AppNu Vasive, Incorporated · 2017
- 1 generation backK211987 ATEC Alignment AppAlphatec Spine, Inc. · 2021
- This deviceK240199 IntraOp Alignment SystemAlphatec Spine, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253216 IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 13 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 12 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 11 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 10 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- 9 generations backK061113 OrthomonAxon Systems, Inc. · 2006
- 8 generations backK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- 7 generations backK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- 6 generations backK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- 5 generations backK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- 4 generations backK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
- 3 generations backK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- 2 generations backK162647 NuVasive NuvaLine Mobile AppNu Vasive, Incorporated · 2017
- 1 generation backK211987 ATEC Alignment AppAlphatec Spine, Inc. · 2021
- This deviceK240199 IntraOp Alignment SystemAlphatec Spine, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −13 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −12 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −11 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −10 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| −9 | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
| −8 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| −7 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| −6 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| −5 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| −4 | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | 1 |
| −3 | K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | 2016 | — |
| −2 | K162647 | NuVasive NuvaLine Mobile App | Nu Vasive, Incorporated | 2017 | — |
| −1 | K211987 | ATEC Alignment App | Alphatec Spine, Inc. | 2021 | — |
| 0 (this device) | K240199 | IntraOp Alignment System | Alphatec Spine, Inc. | 2024 | — |
| +1 | K253216 | IntraOp Alignment System; CONTOUR3D Bending System | Alphatec Spine, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 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.
Planning a device in OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K170800 | NuVasive LessRay with Enhanced TrackingSummary page 4…ETED PREDICATE DEVICES Primary Predicate Trade Name: Nuvasive® LessRay® with Enhanced Tracking 510(k) number: K170800 510(k) Clearance Date: August 18, 2017 Common or Usual Name: Interventional Fluoroscopic X-ray… | 2017 |
| * | K211987 | ATEC Alignment AppSummary page 4…Subsequent Codes: JAA, LLZ Additional Predicate Trade Name: ATEC Alignment App 510(k) number: K211987 510(k) Clearance Date: October 29, 2021 Common or Usual Name: System, Image Processing, Radiol… | 2021 |
| † | K192435 | NuVasive NuvaLine | 2019 |
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 |
|---|---|---|---|
| K253216 | IntraOp Alignment System; CONTOUR3D Bending System | 2026 | 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 40 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 93 ancestors have a recall of any class.
- Of its descendants, K253216 (Alphatec Spine, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K170800.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The IntraOp Alignment System is intended for use in applications where a mobile C-arm fluoroscope is incorporated to aid in diagnosis and treatment during spinal surgery.
The IntraOp Alignment System is also intended to assist healthcare professionals in viewing, storing and measuring spinal alignment assessment images at various time points during surgery as well as planning spinal surgical procedures.
The IntraOp Alignment System is intended for use with patients aged 18 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240199 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240199: IntraOp Alignment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240199
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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