510(k) · Cleared
Cleared“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Point Robotics MedTech, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Feb 20, 2026 as substantially equivalent to K241130 (Point Robotics MedTech, Inc., 2024) and 2 other predicates after a 155-day review. Its family tree reaches back 15 generations to 1986. 3 of the 81 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 20, 2026
- Review
- 155 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K862807 (1986). 80 ancestors in all, the oldest K842956 (1984). No later device cites it as a predicate yet. 3 of the 81 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 11 generations between
- 3 generations backK220241 “POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc. · 2022
- 2 generations backK230087 “POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc. · 2023
- 1 generation backK241130 “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc. · 2024
- This deviceK252989 “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 14 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 13 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 12 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 11 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 10 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 9 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 8 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 7 generations backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 6 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 5 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 4 generations backK160713 Stealth-Midas SystemMedtronic Powered Surgical Solutions · 2016
- 3 generations backK220241 “POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc. · 2022
- 2 generations backK230087 “POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc. · 2023
- 1 generation backK241130 “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc. · 2024
- This deviceK252989 “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −14 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −13 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −12 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −11 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −10 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −9 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −8 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −7 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −6 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| −5 | K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −4 | K160713 | Stealth-Midas System | Medtronic Powered Surgical Solutions | 2016 | — |
| −3 | K220241 | “POINT” Kinguide Robotic-Assisted Surgical System | Point Robotics MedTech, Inc. | 2022 | — |
| −2 | K230087 | “POINT” Kinguide Agile Hybrid Navigation System | Point Robotics MedTech, Inc. | 2023 | — |
| −1 | K241130 | “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) | Point Robotics MedTech, Inc. | 2024 | — |
| 0 (this device) | K252989 | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set | Point Robotics MedTech, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 3 | 1 |
| 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.
3 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 |
|---|---|---|---|
| * | K241130 | “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Summary page 6…where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images. 5. Identification of Legally Marketing Devices K241130 - “POINT” Kinguide Agile Hybrid Navigation System K201189 - Stealthstation™ S8 Spine Software v1.3.0 K201327 - NavLock™ Tra… | 2024 |
| * | K201189 | Stealthstation S8 Spine Software v1.3.0Summary page 6…identified by intraoperative 3D reconstruction images. 5. Identification of Legally Marketing Devices K241130 - “POINT” Kinguide Agile Hybrid Navigation System K201189 - Stealthstation™ S8 Spine Software v1.3.0 K201327 - NavLock™ Trackers Page 2 of 11… | 2020 |
| * | K201327 | NavLock TrackersSummary page 6…es. 5. Identification of Legally Marketing Devices K241130 - “POINT” Kinguide Agile Hybrid Navigation System K201189 - Stealthstation™ S8 Spine Software v1.3.0 K201327 - NavLock™ Trackers Page 2 of 11 Point Rob… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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 · 2 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 3 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 4 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 40 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 19 of the 80 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K241130.
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?
“POINT” Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 to S1 vertebrae (or T1-S1 vertebrae when used with the "POINT" Kinguide RobotArm), and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.
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/K252989 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252989: “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252989
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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