510(k) · Cleared
ClearedS4C Navigation Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant System, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Aug 13, 2013 as substantially equivalent to K053159 (Brainlab AG, 2006) and 7 other predicates after a 137-day review. Its family tree reaches back 11 generations to 1985. 1 of the 60 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.
- Decided
- Aug 13, 2013
- Review
- 137 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 11 generations to K853033 (1985). 46 ancestors in all. 13 later devices descend from it, 2 citing it directly. 1 of the 60 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations between
- 3 generations backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- 2 generations backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- 1 generation backK062327 Modification to S4 Spinal SystemAesculap, Inc. · 2007
- This deviceK130887 S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013
- Descendant · cites it directly · 11 of its ownK181890 Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
- Descendant · 2 generations on · 9 of its ownK192911 Brainlab Compatible K2M Navigation InstrumentsK2m, Inc. · 2019
- Descendant · 3 generations on · 8 of its ownK203205 Navigated Spine InstrumentsStryker Spine · 2021
- Descendant · 4 generations on · 7 of its ownK240662 Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments…Stryker Leibinger GmbH & Co KG · 2024
- Descendant · 5 generations on · 4 of its ownK241171 Spine Guidance Software (Version 5.1); Consolidated Operating Room…Stryker Leibinger GmbH & Co KG · 2024
Show all 11 generations
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 9 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 8 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 7 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 6 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 5 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 4 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- 2 generations backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- 1 generation backK062327 Modification to S4 Spinal SystemAesculap, Inc. · 2007
- This deviceK130887 S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3Ddirect predicate · 2007
Most influential descendants
Showing 5 of 13 · See all- K181890Brainlab Compatible K2M Navigation InstrumentsK2m · 2018 · cites it directly11descendants
- K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc. · 2019 · 2 generations on9descendants
- K203205Navigated Spine InstrumentsStryker Spine · 2021 · 3 generations on8descendants
- K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG · 2024 · 4 generations on7descendants
- K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG · 2024 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −10 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −9 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −8 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −7 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −6 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −5 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K050979 | S4 Spinal System | Aesculap, Inc. | 2005 | — |
| −2 | K060152 | Modification to S4 Spinal System | Aesculap, Inc. | 2006 | — |
| −1 | K062327 | Modification to S4 Spinal System | Aesculap, Inc. | 2007 | — |
| 0 (this device) | K130887 | S4C Navigation Instruments | Aesculap Implant System, Inc. | 2013 | — |
| +1 | K181890 | Brainlab Compatible K2M Navigation Instruments | K2m | 2018 | — |
| +2 | K192911 | Brainlab Compatible K2M Navigation Instruments | K2m, Inc. | 2019 | — |
| +3 | K203205 | Navigated Spine Instruments | Stryker Spine | 2021 | — |
| +4 | K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +5 | K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment… | Stryker Leibinger GmbH & Co KG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 1 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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? (10)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053159 | Vectorvision SpineSummary page 2…effectiveness issues were raised by the performance testing. Clinical data was not needed for the AIS Navigation Instruments. PREDICATE DEVICES * VectorVision Spine - K053159 * Kolibri Spine - K042721 * Trauma -K062358 * VectorVision Fluoro3D - K070106 * Spine & Trauma iCT - K08331 0 * BrainLa… | 2006 |
| * | K042721 | Kolibri SpineSummary page 2…ised by the performance testing. Clinical data was not needed for the AIS Navigation Instruments. PREDICATE DEVICES * VectorVision Spine - K053159 * Kolibri Spine - K042721 * Trauma -K062358 * VectorVision Fluoro3D - K070106 * Spine & Trauma iCT - K08331 0 * BrainLab Trauma - 1100204 " Spine… | 2005 |
| * | K062358 | Modification to Vectorvision TraumaSummary page 2…nce testing. Clinical data was not needed for the AIS Navigation Instruments. PREDICATE DEVICES * VectorVision Spine - K053159 * Kolibri Spine - K042721 * Trauma -K062358 * VectorVision Fluoro3D - K070106 * Spine & Trauma iCT - K08331 0 * BrainLab Trauma - 1100204 " Spine & Trauma 3D - K0701… | 2007 |
| * | K070106 | VV Fluoro 3DSummary page 2…eeded for the AIS Navigation Instruments. PREDICATE DEVICES * VectorVision Spine - K053159 * Kolibri Spine - K042721 * Trauma -K062358 * VectorVision Fluoro3D - K070106 * Spine & Trauma iCT - K08331 0 * BrainLab Trauma - 1100204 " Spine & Trauma 3D - K070106 * Spine & Trauma 2D / Fluro Exp… | 2007 |
| * | K083310 | Spine & Trauma IctSummary page 2…ruments. PREDICATE DEVICES * VectorVision Spine - K053159 * Kolibri Spine - K042721 * Trauma -K062358 * VectorVision Fluoro3D - K070106 * Spine & Trauma iCT - K08331 0 * BrainLab Trauma - 1100204 " Spine & Trauma 3D - K070106 * Spine & Trauma 2D / Fluro Express - K1 10204 * Aesculap S4C S… | 2009 |
| Kept off the family tree | K100204 | FDA’s K100204 is Sonalis Our reading of the summary gave K100204, FDA’s number for Sonalis (Smith Associates). Its FDA name has none of the distinctive words the summary uses for the device it names, “BrainLab Trauma”. Kept off the family tree. Summary page 2…VectorVision Spine - K053159 * Kolibri Spine - K042721 * Trauma -K062358 * VectorVision Fluoro3D - K070106 * Spine & Trauma iCT - K08331 0 * BrainLab Trauma - 1100204 " Spine & Trauma 3D - K070106 * Spine & Trauma 2D / Fluro Express - K1 10204 * Aesculap S4C Spinal System (K050797, K0601 5… | 2010 |
| * | K110204 | Brainlab TraumaSummary page 2…* VectorVision Fluoro3D - K070106 * Spine & Trauma iCT - K08331 0 * BrainLab Trauma - 1100204 " Spine & Trauma 3D - K070106 * Spine & Trauma 2D / Fluro Express - K1 10204 * Aesculap S4C Spinal System (K050797, K0601 52, K062327) DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2011 |
| Kept off the family tree | K050797 | FDA’s K050797 is Tissu-Trans Our reading of the summary gave K050797, FDA’s number for Tissu-Trans (Shippert Medical Technologies Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Aesculap S4C Spinal System”. Kept off the family tree. Summary page 2…ne & Trauma iCT - K08331 0 * BrainLab Trauma - 1100204 " Spine & Trauma 3D - K070106 * Spine & Trauma 2D / Fluro Express - K1 10204 * Aesculap S4C Spinal System (K050797, K0601 52, K062327) DEPARTMENT OF HEALTH & HUMAN SERVICES Public Heal… | 2005 |
| * | K060152 | Modification to S4 Spinal SystemSummary page 2…ma iCT - K08331 0 * BrainLab Trauma - 1100204 " Spine & Trauma 3D - K070106 * Spine & Trauma 2D / Fluro Express - K1 10204 * Aesculap S4C Spinal System (K050797, K0601 52, K062327) DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2006 |
| * | K062327 | Modification to S4 Spinal SystemSummary page 2…08331 0 * BrainLab Trauma - 1100204 " Spine & Trauma 3D - K070106 * Spine & Trauma 2D / Fluro Express - K1 10204 * Aesculap S4C Spinal System (K050797, K0601 52, K062327) DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2007 |
What descends from it? (13)
See all 132 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 · Direct predicate · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 46 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K181890 (K2m, 2018) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K053159.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Aesculap S4 Cervical Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. They are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image 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 during the navigation of pedicle screws (T1-T3).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130887: S4C Navigation Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130887
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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