510(k) · Cleared
ClearedSpine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger GmbH & Co KG · OLO Orthopedic Stereotaxic Instrument
Cleared on Jun 6, 2024 as substantially equivalent to K220593 (Stryker Leibinger GmbH & Co KG, 2022) and 3 other predicates after a 90-day review. Its family tree reaches back 15 generations to 1985. 1 of the 76 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Jun 6, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K853033 (1985). 68 ancestors in all. 7 later devices descend from it, 4 citing it directly. 1 of the 76 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations between
- 3 generations backK181890 Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
- 2 generations backK192911 Brainlab Compatible K2M Navigation InstrumentsK2m, Inc. · 2019
- 1 generation backK203205 Navigated Spine InstrumentsStryker Spine · 2021
- This deviceK240662 Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments…Stryker Leibinger GmbH & Co KG · 2024
- Descendant · cites it directly · 4 of its ownK241171 Spine Guidance Software (Version 5.1); Consolidated Operating Room…Stryker Leibinger GmbH & Co KG · 2024
- Descendant · 2 generations on · 2 of its ownK241517 Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024
- Descendant · cites it directly · 1 of its ownK252871 Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q…Stryker Leibinger GmbH & Co KG · 2026
- Descendant · cites it directly · 0 of its ownK260546 Q Pedicle InstrumentsK2m, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK253623 Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine…Stryker Leibinger GmbH & Co KG · 2026
Show all 15 generations
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 13 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 12 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 11 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 10 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 9 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 8 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- 6 generations backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- 5 generations backK062327 Modification to S4 Spinal SystemAesculap, Inc. · 2007
- 4 generations backK130887 S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013
- 3 generations backK181890 Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
- 2 generations backK192911 Brainlab Compatible K2M Navigation InstrumentsK2m, Inc. · 2019
- 1 generation backK203205 Navigated Spine InstrumentsStryker Spine · 2021
- This deviceK240662 Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments…Stryker Leibinger GmbH & Co KG · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3D5 generations back · 2007
Most influential descendants
Showing 5 of 7 · See all- K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG · 2024 · cites it directly4descendants
- K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024 · 2 generations on2descendants
- K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG · 2026 · cites it directly1descendant
- K260546Q Pedicle InstrumentsK2m, Inc. · 2026 · cites it directly0descendants
- K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −14 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −13 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −12 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −11 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −10 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −9 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −8 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K050979 | S4 Spinal System | Aesculap, Inc. | 2005 | — |
| −6 | K060152 | Modification to S4 Spinal System | Aesculap, Inc. | 2006 | — |
| −5 | K062327 | Modification to S4 Spinal System | Aesculap, Inc. | 2007 | — |
| −4 | K130887 | S4C Navigation Instruments | Aesculap Implant System, Inc. | 2013 | — |
| −3 | K181890 | Brainlab Compatible K2M Navigation Instruments | K2m | 2018 | — |
| −2 | K192911 | Brainlab Compatible K2M Navigation Instruments | K2m, Inc. | 2019 | — |
| −1 | K203205 | Navigated Spine Instruments | Stryker Spine | 2021 | — |
| 0 (this device) | K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +1 | K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +2 | K241517 | Q Guidance System; Mako Spine System; | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +1 | K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments… | Stryker Leibinger GmbH & Co KG | 2026 | — |
| +1 | K260546 | Q Pedicle Instruments | K2m, Inc. | 2026 | — |
| +2 | K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4… | Stryker Leibinger GmbH & Co KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 1 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 K252597 Valence Robotic Navigation System; Valence…score 23.5 · 33 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K220593 | Spine Guidance Software, Stryker Q Guidance SystemSummary page 7…of 7 807.92(a)(3) – Legally marketed device(s) to which equivalence is claimed Spine Guidance Software, v5.0 Spine Guidance Software, v4.0, K220593 Q Pedicle Instruments Navigated Spine Instruments, K203205, K172034 Consolidated Operating Room Eq… | 2022 |
| * | K203205 | Navigated Spine InstrumentsSummary page 7…imed Spine Guidance Software, v5.0 Spine Guidance Software, v4.0, K220593 Q Pedicle Instruments Navigated Spine Instruments, K203205, K172034 Consolidated Operating Room Equipment Stryker Consolidated Operating Room Equipment (CORE) 2 Console… | 2021 |
| * | K172034 | Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock…Summary page 7…e Guidance Software, v5.0 Spine Guidance Software, v4.0, K220593 Q Pedicle Instruments Navigated Spine Instruments, K203205, K172034 Consolidated Operating Room Equipment Stryker Consolidated Operating Room Equipment (CORE) 2 Console… | 2017 |
| * | K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleSummary page 7…Consolidated Operating Room Equipment Stryker Consolidated Operating Room Equipment (CORE) 2 Console (CORE) 2 Console, K171840 Electric System 6 Heavy Duty Dual Trigger FDA Product Code: HWE (Instrument, Surgical, Rotary Handpiece… | 2017 |
| * | — | Instrument, Surgical, Orthopedic, AC-Powered Motor and Accessory/Attachment Named without a submission number |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 5 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 11 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 68 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K241171 (Stryker Leibinger GmbH & Co KG, 2024) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K220593.
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?
The Q Guidance System, when used with the Spine Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients. The system is indicated for any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid…
Read the full statement (407 words)
The Q Guidance System, when used with the Spine Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients. The system is indicated for any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified. The system assists in the positioning of instruments for procedures on the pelvis and spine, including: Screw and Needle placement in the spine or pelvis.
Stryker Spine Q Pedicle Instruments are intended to be used as accessories to the Stryker Spine Guidance System to facilitate placement of Stryker Spine implants. They can be navigated instruments or non-navigated manual instruments. When navigated, Stryker Spine Q Pedicle Instruments are specifically designed for use with the Spine Guidance Software. They are intended to be used with a Q Navigation Adaptor and associated trackers manually or under power with a Stryker Rotary Handpiece to facilitate pedicle preparation and placement of Stryker Spine implants in the non-cervical spine in adult and pediatric (adolescent) patients in accordance with the Indications and contraindications of the associated Stryker Spine Implant System.
The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to orthopedic, dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The CORE 2 Console is also indicated as an accessory to the Stryker Spine Guidance Software for stereotactic surgical procedures on the spine in adult and pediatric (adolescent) patients.
The Stryker Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece is used with the Consolidated Operating Room Equipment (CORE™) System. When used with a variety of Stryker-approved attachments, the handpiece is intended for orthopedic surgical procedures involving drilling, reaming, driving wire or pins, cutting bone and hard tissue. The Stryker Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece, when used in conjunction with Stryker Spine Guidance Software, is intended to be used to facilitate preparation and placement of screws of Stryker Spine implant systems in adult and pediatric (adolescent) patients.
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/K240662 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240662: Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240662
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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