510(k) · Cleared
ClearedNavigated Spine Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · OLO Orthopedic Stereotaxic Instrument
Cleared on Mar 23, 2021 as substantially equivalent to K172034 (Stryker Corporation, 2017) and 1 other predicate after a 144-day review. Its family tree reaches back 14 generations to 1985. 1 of the 73 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Mar 23, 2021
- Review
- 144 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K853033 (1985). 64 ancestors in all. 8 later devices descend from it, 1 citing it directly. 1 of the 73 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK130887 S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013
- 2 generations backK181890 Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
- 1 generation backK192911 Brainlab Compatible K2M Navigation InstrumentsK2m, Inc. · 2019
- This deviceK203205 Navigated Spine InstrumentsStryker Spine · 2021
- Descendant · cites it directly · 7 of its ownK240662 Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments…Stryker Leibinger GmbH & Co KG · 2024
- Descendant · 2 generations on · 4 of its ownK241171 Spine Guidance Software (Version 5.1); Consolidated Operating Room…Stryker Leibinger GmbH & Co KG · 2024
- Descendant · 3 generations on · 2 of its ownK241517 Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024
- Descendant · 2 generations on · 1 of its ownK252871 Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q…Stryker Leibinger GmbH & Co KG · 2026
- Descendant · 2 generations on · 0 of its ownK260546 Q Pedicle InstrumentsK2m, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- 5 generations backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- 4 generations backK062327 Modification to S4 Spinal SystemAesculap, Inc. · 2007
- 3 generations backK130887 S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013
- 2 generations backK181890 Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
- 1 generation backK192911 Brainlab Compatible K2M Navigation InstrumentsK2m, Inc. · 2019
- This deviceK203205 Navigated Spine InstrumentsStryker Spine · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3D4 generations back · 2007
Most influential descendants
Showing 5 of 8 · See all- K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG · 2024 · cites it directly7descendants
- K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG · 2024 · 2 generations on4descendants
- K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024 · 3 generations on2descendants
- K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG · 2026 · 2 generations on1descendant
- K260546Q Pedicle InstrumentsK2m, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K050979 | S4 Spinal System | Aesculap, Inc. | 2005 | — |
| −5 | K060152 | Modification to S4 Spinal System | Aesculap, Inc. | 2006 | — |
| −4 | K062327 | Modification to S4 Spinal System | Aesculap, Inc. | 2007 | — |
| −3 | K130887 | S4C Navigation Instruments | Aesculap Implant System, Inc. | 2013 | — |
| −2 | K181890 | Brainlab Compatible K2M Navigation Instruments | K2m | 2018 | — |
| −1 | K192911 | Brainlab Compatible K2M Navigation Instruments | K2m, Inc. | 2019 | — |
| 0 (this device) | K203205 | Navigated Spine Instruments | Stryker Spine | 2021 | — |
| +1 | K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +2 | K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +3 | K241517 | Q Guidance System; Mako Spine System; | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +2 | K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments… | Stryker Leibinger GmbH & Co KG | 2026 | — |
| +2 | K260546 | Q Pedicle Instruments | K2m, Inc. | 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 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 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 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 |
|---|---|---|---|
| * | K172034 | Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock…Summary page 5…ation Name: Orthopedic / Orthopedic Stereotaxic Instruments Regulation Number 21 CFR 882.4560 Product Code: OLO Predicate Devices: Primary Predicate: K172034 Spine Map 3D 3.1 Additional Predicate: K192911 Brainlab Compatible K2M Navigation Instruments… | 2017 |
| * | K192911 | Brainlab Compatible K2M Navigation InstrumentsSummary page 5…n Number 21 CFR 882.4560 Product Code: OLO Predicate Devices: Primary Predicate: K172034 Spine Map 3D 3.1 Additional Predicate: K192911 Brainlab Compatible K2M Navigation Instruments Reference Predicate: K183196 SpineMap Go Device Descripti… | 2019 |
| † | K183196 | Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers… | 2019 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q… | 2024 | 7 |
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 · 4 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 64 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K240662 (Stryker Leibinger GmbH & Co KG, 2024) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K172034.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Navigated Everest Instruments The Navigated Everest Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants. The Navigated Everest Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and…
Read the full statement (668 words)
Navigated Everest Instruments
The Navigated Everest Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Everest Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition 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 can be identified.
The Navigated Everest Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Everest Spinal Fixation System using the Stryker Spine Navigation System.
Navigated Mesa Instruments
The Navigated Mesa Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Mesa Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition 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 can be identified.
The Navigated Mesa Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Mesa Spinal Fixation System using the Stryker Spine Navigation System.
Navigated Yukon Instruments
The Navigated Yukon Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Yukon Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition 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 can be identified.
The Navigated Yukon Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Yukon Spinal Fixation System using the Stryker Spine Navigation System.
Navigated Xia 4.5- Xia CT Taps
The Navigated Xia 4.5- Xia CT Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 4.5- Xia CT Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition 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 can be identified.
The Navigated Xia 4.5- Xia CT Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 4.5- Xia CT Spinal Fixation System using the Stryker Spine Navigation System.
Navigated Xia 3- Serrato Deformity Screwdriver
The Navigated Xia 3- Serrato Deformity Screwdriver is intended to be used as an accessory to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3- Serrato Deformity Screwdriver may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition 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 can be identified.
The Navigated Xia 3- Serrato Deformity Screwdriver is intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine XIA® 3 and ES2® Spinal Fixation Systems using the Stryker Spine Navigation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203205 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203205: Navigated Spine Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203205
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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