510(k) · Cleared
ClearedRobotic Integration Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Synthes · OLO Orthopedic Stereotaxic Instrument
Cleared on Jun 17, 2024 as substantially equivalent to K200791 (Medos International SARL, 2020) and 1 other predicate after a 263-day review. Its family tree reaches back 21 generations to 2001. 1 of the 646 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 17, 2024
- Review
- 263 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K003155 (2001). 645 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 646 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 17 generations between
- 3 generations backK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- 2 generations backK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- 1 generation backK220862 E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022
- This deviceK233256 Robotic Integration InstrumentsDePuy Synthes · 2024
Show all 21 generations
- Root · 21 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 20 generations backK012254 VBROsteotech, Inc. · 2001
- 19 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 18 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 17 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 16 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 12 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 11 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 9 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 7 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 6 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- 5 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 4 generations backK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- 3 generations backK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- 2 generations backK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- 1 generation backK220862 E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022
- This deviceK233256 Robotic Integration InstrumentsDePuy Synthes · 2024
Class I recalls in this family
- K100952 Modification to Synthes Matrix System5 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −20 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −19 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −18 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −17 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −16 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −12 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −11 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −9 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −7 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| −6 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| −5 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| −4 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
| −3 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
| −2 | K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017 | — |
| −1 | K220862 | E-GPS Navigated Instruments | Precision Spine, Inc. | 2022 | — |
| 0 (this device) | K233256 | Robotic Integration Instruments | DePuy Synthes | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 8 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 21 | 0 |
| 1996 | 19 | 0 |
| 1997 | 16 | 0 |
| 1998 | 28 | 0 |
| 1999 | 20 | 0 |
| 2000 | 40 | 0 |
| 2001 | 41 | 0 |
| 2002 | 35 | 0 |
| 2003 | 32 | 0 |
| 2004 | 49 | 0 |
| 2005 | 50 | 0 |
| 2006 | 36 | 0 |
| 2007 | 19 | 0 |
| 2008 | 38 | 0 |
| 2009 | 30 | 0 |
| 2010 | 26 | 1 |
| 2011 | 25 | 0 |
| 2012 | 14 | 0 |
| 2013 | 9 | 0 |
| 2014 | 8 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K200791 | Navigation Enabled IntrumentsSummary page 4…Classification Product and OLO – Neurology Panel Code D. Predicate Device Names Primary Predicate Device: Navigation Enabled Instruments (K200791) – OLO Additional Predicate Device: E-GPS Navigated Instruments (K220862) – OLO Reference Device: TriALTI… | 2020 |
| * | K220862 | E-GPS Navigated InstrumentsSummary page 4…e Device Names Primary Predicate Device: Navigation Enabled Instruments (K200791) – OLO Additional Predicate Device: E-GPS Navigated Instruments (K220862) – OLO Reference Device: TriALTIS Navigation Enabled Instruments (K231527) – OLO… | 2022 |
| † | K231527 | TriALTIS Navigation Enabled Instruments | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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
What does this lineage say?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 82 of the 645 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K200791.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Robotic Integration Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Robotic Integration Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS Robotic-Assisted Solution…
Read the full statement (192 words)
Robotic Integration Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Robotic Integration Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS Robotic-Assisted Solution for Spine. The Robotic Integration Instruments are indicated for use in surgical spinal procedures, in which:
* the use of EXPEDIUM, VIPER, TriALTIS and SYMPHONY OCT is indicated,
* the use of stereotactic surgery may be appropriate, and
* reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (eg. CT or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
These procedures include but are not limited to spinal fusion. The Robotic Integration Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.
The Robotic Integration Instruments used in conjunction with the SYMPHONY OCT system are intended to support indicated cervical and thoracic polyaxial screw placement only.
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/K233256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233256: Robotic Integration Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233256
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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