510(k) · Cleared
ClearedRobotic Graft Delivery Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 18, 2023 as substantially equivalent to K182121 (Medtronic Sofamor Danek USA, Inc., 2018) and 1 other predicate after a 125-day review. Its family tree reaches back 19 generations to 1994. 4 of the 135 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 18, 2023
- Review
- 125 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K911783 (1994). 134 ancestors in all, the oldest K811452 (1981). No later device cites it as a predicate yet. 4 of the 135 devices in this family, counting this one, have a Class I recall.
- Root · 19 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 15 generations between
- 3 generations backK200935 Mazor XMazor Robotics, Ltd. · 2020
- 2 generations backK203005 Mazor XMazor Robotics, Ltd. · 2020 · Recalled
- 1 generation backK230064 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2023 · Recalled
- This deviceK230716 Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc. · 2023
Show all 19 generations
- Root · 19 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 18 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 17 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 16 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 15 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 14 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 13 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 12 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 11 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 10 generations backK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- 9 generations backK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- 8 generations backK120812 RenaissanceMazor Robotics, Ltd. · 2012 · Recalled
- 7 generations backK152041 Renaissance X SystemMazor Robotics, Ltd. · 2015
- 6 generations backK163221 Mazor XMazor Robotics, Ltd. · 2017
- 5 generations backK180307 Mazor XMazor Robotics, Ltd. · 2018
- 4 generations backK182077 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · Recalled
- 3 generations backK200935 Mazor XMazor Robotics, Ltd. · 2020
- 2 generations backK203005 Mazor XMazor Robotics, Ltd. · 2020 · Recalled
- 1 generation backK230064 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2023 · Recalled
- This deviceK230716 Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, 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 |
|---|---|---|---|---|---|
| −19 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −18 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −17 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −16 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −15 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −14 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −13 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −12 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| −11 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| −10 | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| −9 | K113228 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| −8 | K120812 | Renaissance | Mazor Robotics, Ltd. | 2012 | 1 |
| −7 | K152041 | Renaissance X System | Mazor Robotics, Ltd. | 2015 | — |
| −6 | K163221 | Mazor X | Mazor Robotics, Ltd. | 2017 | — |
| −5 | K180307 | Mazor X | Mazor Robotics, Ltd. | 2018 | — |
| −4 | K182077 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2018 | 2 |
| −3 | K200935 | Mazor X | Mazor Robotics, Ltd. | 2020 | — |
| −2 | K203005 | Mazor X | Mazor Robotics, Ltd. | 2020 | 1 |
| −1 | K230064 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2023 | 2 |
| 0 (this device) | K230716 | Robotic Graft Delivery Instruments | Medtronic Sofamor Danek, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 10 | 0 |
| 1996 | 3 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 10 | 1 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 2 | 1 |
| 2018 | 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.
4 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 |
|---|---|---|---|
| * | K182121 | CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionSummary page 4…cation: Class II Product Code: OLO III. Predicate Devices: Primary Predicate: CD HORIZON Spinal System Non-navigated, Guided Instruments (K182121, S.E 11/08/2018) Reference Predicate: Mazor X System (Mazor X Stealth Edition) (K230064 S.E. 04/07/2023)… | 2018 |
| * | K230064 | Mazor X System (Mazor X Stealth Edition) Cleared while this submission was under review Summary page 4…ON Spinal System Non-navigated, Guided Instruments (K182121, S.E 11/08/2018) Reference Predicate: Mazor X System (Mazor X Stealth Edition) (K230064 S.E. 04/07/2023) Reference Predicate: Graft Gun (Medtronic Class I Exempt) The predicate devices have not… | 2023 |
| * | — | Graft Gun Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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.
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 5 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 6 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 7 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 13 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 30 of the 134 ancestors have a recall of any class; 4 have a Class I recall.
- 4 other devices also cite its predicate K182121.
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?
Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the Mazor X Stealth™ Edition, which is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where…
Read the full statement (246 words)
Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the Mazor X Stealth™ Edition, which is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the Mazor X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument. Medtronic cannulas may or may not be used with Midas Rex™ attachments and tools.
Do not implant instruments.
Medtronic does not and cannot warrant the use of these instruments nor any of the component parts upon which repairs have been made or attempted, except as performed by Medtronic or an authorized Medtronic repair representative. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230716: Robotic Graft Delivery Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230716
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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