510(k) · Cleared
Recalled · Class II · 2026ATEC Lateral Navigation Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Mar 23, 2023 as substantially equivalent to K192336 (Medtronic Sofamor Danek USA, Inc., 2019) and 2 other predicates after a 98-day review. Its family tree reaches back 20 generations to 2001. 2 of the 574 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times.
- Decided
- Mar 23, 2023
- Review
- 98 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 20 generations to K003155 (2001). 573 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 2 of the 574 devices in this family, counting this one, have a Class I recall.
- Root · 20 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations between
- 3 generations backK191039 Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019
- 2 generations backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK200719 NuVasive Navigation.S InstrumentsNu Vasive, Incorporated · 2020
- This deviceK223765 ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc. · 2023
Show all 20 generations
- Root · 20 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 19 generations backK012254 VBROsteotech, Inc. · 2001
- 18 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 17 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 16 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 15 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 10 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 9 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 7 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 6 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 5 generations backK142559 ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 4 generations backK163581 Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017
- 3 generations backK191039 Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019
- 2 generations backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK200719 NuVasive Navigation.S InstrumentsNu Vasive, Incorporated · 2020
- This deviceK223765 ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc. · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −19 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −18 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −17 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −16 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −15 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −10 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −9 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −7 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −6 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −5 | K142559 | ELEVATE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −4 | K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| −3 | K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −2 | K192336 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −1 | K200719 | NuVasive Navigation.S Instruments | Nu Vasive, Incorporated | 2020 | — |
| 0 (this device) | K223765 | ATEC Lateral Navigation Instruments | Alphatec Spine, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1984 | 3 | 0 |
| 1985 | 3 | 0 |
| 1986 | 3 | 0 |
| 1987 | 4 | 0 |
| 1988 | 4 | 0 |
| 1989 | 4 | 0 |
| 1990 | 8 | 0 |
| 1991 | 4 | 0 |
| 1992 | 10 | 0 |
| 1993 | 10 | 1 |
| 1994 | 17 | 0 |
| 1995 | 23 | 0 |
| 1996 | 15 | 0 |
| 1997 | 17 | 0 |
| 1998 | 20 | 0 |
| 1999 | 28 | 0 |
| 2000 | 30 | 0 |
| 2001 | 27 | 0 |
| 2002 | 29 | 0 |
| 2003 | 30 | 0 |
| 2004 | 45 | 0 |
| 2005 | 37 | 1 |
| 2006 | 24 | 0 |
| 2007 | 20 | 0 |
| 2008 | 30 | 0 |
| 2009 | 20 | 0 |
| 2010 | 13 | 0 |
| 2011 | 20 | 0 |
| 2012 | 14 | 0 |
| 2013 | 9 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2019 | 3 | 0 |
| 2022 | 2 | 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.
2 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? (3)
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 |
|---|---|---|---|
| * | K192336 | Navigated Anterolateral Disc Prep InstrumentsSummary page 4…LLY MARKETED PREDICATE DEVICES Primary Predicate Device: 510(k) Product Name Clearance Date K192336 Navigated Anterolateral Disc Prep Instruments November 22, 2019 Additional Predicate Devices:… | 2019 |
| * | K221821 | ATEC IOM Accessory InstrumentsSummary page 4…November 22, 2019 Additional Predicate Devices: 510(k) Product Name Clearance Date K221821 ATEC IOM Accessory Instruments September 23, 2022 K200719 NuVasive Navigatio… | 2022 |
| * | K200719 | NuVasive Navigation.S InstrumentsSummary page 4…Product Name Clearance Date K221821 ATEC IOM Accessory Instruments September 23, 2022 K200719 NuVasive Navigation Instruments December 2, 2020 IV. DEVICE DESCRIPTION The ATEC Lat… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 2, 2026 | Class II | Z-1343-2026 | Device Design | Due a design issue where the navigated array connection geometry is incorrect. |
| Jan 2, 2026 | Class II | Z-1342-2026 | Device Design | Due a design issue where the navigated array connection geometry is incorrect. |
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.
What does this lineage say?
- The line of descent spans 22 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 68 of the 573 ancestors have a recall of any class; 2 have a Class I recall.
- 3 other devices also cite its predicate K192336.
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?
The ATEC Lateral Navigation Instruments are intended to facilitate discectomy, boney resection, implant selection, and access during spinal surgery. Navigated instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a…
Read the full statement (120 words)
The ATEC Lateral Navigation Instruments are intended to facilitate discectomy, boney resection, implant selection, and access during spinal surgery. Navigated instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The Stimulating Initial Dilator may also be utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.
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/K223765 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223765: ATEC Lateral Navigation Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223765
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