510(k) · Cleared
ClearedValence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
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 Feb 19, 2026 as substantially equivalent to K232413 (Alphatec Spine, Inc., 2023) and 6 other predicates after a 188-day review. Its family tree reaches back 33 generations to 1984. 7 of the 1,562 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Feb 19, 2026
- Review
- 188 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 33 generations to K841189 (1984). 1,560 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 7 of the 1,562 devices in this family, counting this one, have a Class I recall.
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 29 generations between
- 3 generations backK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 2 generations backK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- 1 generation backK240951 Invictus Robotic Navigation InstrumentsAlphatec Spine · 2024
- This deviceK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal…Alphatec Spine, Inc. · 2026
Show all 33 generations
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 32 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 31 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 30 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 29 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 28 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 27 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 26 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 25 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 24 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 23 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 22 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 21 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 20 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 19 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 18 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 17 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 16 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 15 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 14 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 13 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 12 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 11 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 10 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 9 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 8 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 7 generations backK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- 6 generations backK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- 5 generations backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- 4 generations backK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 3 generations backK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 2 generations backK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- 1 generation backK240951 Invictus Robotic Navigation InstrumentsAlphatec Spine · 2024
- This deviceK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation 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 |
|---|---|---|---|---|---|
| −33 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −32 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −31 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −30 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −29 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −28 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −27 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −26 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −25 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −24 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −23 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −22 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −21 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −20 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −19 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −18 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −17 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −16 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −15 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −14 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −13 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −12 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −11 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −10 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −9 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −8 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −7 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| −6 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| −5 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| −4 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| −3 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| −2 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| −1 | K240951 | Invictus Robotic Navigation Instruments | Alphatec Spine | 2024 | — |
| 0 (this device) | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
| +1 | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation… | Alphatec Spine, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 4 | 0 |
| 1989 | 6 | 0 |
| 1990 | 5 | 0 |
| 1991 | 7 | 0 |
| 1992 | 13 | 0 |
| 1993 | 10 | 0 |
| 1994 | 13 | 0 |
| 1995 | 26 | 0 |
| 1996 | 26 | 0 |
| 1997 | 21 | 0 |
| 1998 | 38 | 0 |
| 1999 | 36 | 0 |
| 2000 | 50 | 0 |
| 2001 | 69 | 1 |
| 2002 | 56 | 0 |
| 2003 | 64 | 0 |
| 2004 | 91 | 0 |
| 2005 | 90 | 0 |
| 2006 | 67 | 0 |
| 2007 | 65 | 0 |
| 2008 | 113 | 1 |
| 2009 | 81 | 0 |
| 2010 | 79 | 2 |
| 2011 | 87 | 0 |
| 2012 | 61 | 0 |
| 2013 | 54 | 0 |
| 2014 | 62 | 0 |
| 2015 | 64 | 1 |
| 2016 | 48 | 1 |
| 2017 | 43 | 1 |
| 2018 | 21 | 0 |
| 2019 | 15 | 0 |
| 2020 | 12 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 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.
7 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? (7)
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 |
|---|---|---|---|
| * | K232413 | Fusion Robotic Navigation SystemSummary page 5…OLO LEGALLY MARKETED PREDICATE DEVICES Primary Predicate: 510(k) Product Name Product Code Clearance Date K232413 Fusion Robotic Navigation System OLO 09/08/2023… | 2023 |
| * | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Summary page 6…ValenceTM Robotic Navigation System Additional Predicates: 510(k) Product Name Product Code Clearance Date K161210 Medtronic Navigated Manual Reusable OLO, OUR, 08/12/2016 Instruments for use with th… | 2016 |
| * | K232345 | ATEC Posterior Navigated Disc Prep InstrumentsSummary page 6…Manual Reusable OLO, OUR, 08/12/2016 Instruments for use with the HWE StealthStation™ K232345 ATEC Posterior Navigated Disc Prep OLO 11/02/2023 Instruments K24095… | 2023 |
| * | K240951 | Invictus Robotic Navigation InstrumentsSummary page 6…StealthStation™ K232345 ATEC Posterior Navigated Disc Prep OLO 11/02/2023 Instruments K240951 Invictus Robotic Navigation Instruments OLO 06/06/2024 K200936 Invictus™ CT Spinal Fixation… | 2024 |
| * | K200936 | Invictus™ CT Spinal Fixation SystemSummary page 6…OLO 11/02/2023 Instruments K240951 Invictus Robotic Navigation Instruments OLO 06/06/2024 K200936 Invictus™ CT Spinal Fixation System NKG 05/22/2020 K232275 Invictus® Spinal Fixation S… | 2020 |
| * | K232275 | Invictus® Spinal Fixation SystemSummary page 6…ictus Robotic Navigation Instruments OLO 06/06/2024 K200936 Invictus™ CT Spinal Fixation System NKG 05/22/2020 K232275 Invictus® Spinal Fixation System NKB, KWP, 09/27/2023… | 2023 |
| * | K234092 | SafeOp 3: Neural Informatix SysteemSummary page 6…KB, KWP, 09/27/2023 KWQ, OUR, PML K234092 SafeOp 3: Neural Informatix System GWF, GXY, 04/19/2024… | 2024 |
| † | K211616 | ExcelsiusHub | 2021 |
| † | K192938 | Invictus™ Spinal Fixation System | 2019 |
| † | K161363 | Arsenal Spinal Fixation System | 2016 |
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 |
|---|---|---|---|
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | 2026 | 0 |
Has anything in its family been recalled? (7 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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 6 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 7 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 8 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 8 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 14 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 42 years and passes through 14 companies; a new generation was cleared every 9 months on median.
- 208 of the 1,560 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K261284 (Alphatec Spine, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Valence Robotic Navigation System: Valence Robotic Navigation System is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan. The…
Read the full statement (216 words)
Valence Robotic Navigation System:
Valence Robotic Navigation System is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan.
The Valence Robotic Navigation System is indicated for assisting surgeons in spinal procedures, such as:
• Pedicle screw placement
• Interbody device placement
Valence Robotic Navigation Instruments (for use with the StealthStation™):
The Valence Posterior Disc Prep Instruments are indicated to facilitate discectomy, bony resection, and implant selection during spinal surgery.
The Valence Posterior Fixation Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252597
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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