510(k) · Cleared
ClearedATEC Alignment App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 29, 2021 as substantially equivalent to K141669 (Nemaris, Inc., 2014) and 1 other predicate after a 123-day review. Its family tree reaches back 13 generations to 1984. 2 later devices descend from it.
- Decided
- Oct 29, 2021
- Review
- 123 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K842956 (1984). 87 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 9 generations between
- 3 generations backK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
- 2 generations backK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- 1 generation backK162647 NuVasive NuvaLine Mobile AppNu Vasive, Incorporated · 2017
- This deviceK211987 ATEC Alignment AppAlphatec Spine, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK240199 IntraOp Alignment SystemAlphatec Spine, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253216 IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 12 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 11 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 10 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 9 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- 8 generations backK061113 OrthomonAxon Systems, Inc. · 2006
- 7 generations backK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- 6 generations backK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- 5 generations backK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- 4 generations backK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- 3 generations backK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
- 2 generations backK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- 1 generation backK162647 NuVasive NuvaLine Mobile AppNu Vasive, Incorporated · 2017
- This deviceK211987 ATEC Alignment AppAlphatec Spine, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −12 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −11 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −10 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −9 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| −8 | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
| −7 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| −6 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| −5 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| −4 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| −3 | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | 1 |
| −2 | K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | 2016 | — |
| −1 | K162647 | NuVasive NuvaLine Mobile App | Nu Vasive, Incorporated | 2017 | — |
| 0 (this device) | K211987 | ATEC Alignment App | Alphatec Spine, Inc. | 2021 | — |
| +1 | K240199 | IntraOp Alignment System | Alphatec Spine, Inc. | 2024 | — |
| +2 | 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 | 8 | 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 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 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? (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 |
|---|---|---|---|
| * | K141669 | SurgimapSummary page 4…LY MARKETED PREDICATE DEVICES 510(k) Product Code Trade Name Manufacturer Primary Predicate Device K141669 LLZ Surgimap 2.0 Nemaris, Inc. Additional Predicate Device K1… | 2014 |
| * | K162647 | NuVasive NuvaLine Mobile AppSummary page 4…Primary Predicate Device K141669 LLZ Surgimap 2.0 Nemaris, Inc. Additional Predicate Device K162647 LLZ NuVasive NuvaLine Mobile App NuVasive, Inc. IV. DEVICE DESCRIPTION The ATEC A… | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240199 | IntraOp Alignment System | 2024 | 1 |
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 37 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 87 ancestors have a recall of any class.
- Of its descendants, K240199 (Alphatec Spine, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K141669.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The ATEC Alignment App assists healthcare professionals in viewing, measuring, and storing images as well as planning orthopedic surgeries. The app allows the healthcare professional to perform generic and specialty measurements of the images, and to plan surgical procedures. The app includes tools for measuring anatomical components for implant selection, and offers the possibility to share data among ATEC Alignment App users. The app is for planning use only and is not intended for primary diagnostic use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211987: ATEC Alignment App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211987
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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