510(k) · Cleared
ClearedAltus Spine Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altus Partners, LLC · OLO Orthopedic Stereotaxic Instrument
Cleared on May 8, 2025 as substantially equivalent to K170679 (Medtronic Sofamor Danek, 2017) and 2 other predicates after a 185-day review. Its family tree reaches back 21 generations to 1985. 1 of the 390 devices in its family, counting itself, has a Class I recall.
- Decided
- May 8, 2025
- Review
- 185 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 21 generations to K853033 (1985). 389 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 390 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 17 generations between
- 3 generations backK200922 Altus Spine HA Pedicle Screw SystemAltus Partners, LLC · 2021
- 2 generations backK211027 Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2022
- 1 generation backK230766 Altus Spine Monaco Pedicle Screw SystemAltus Spine · 2023
- This deviceK243419 Altus Spine Navigation SystemAltus Partners, LLC · 2025
Show all 21 generations
- Root · 21 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 20 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 19 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 18 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 17 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 16 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 15 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 14 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 13 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 12 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 11 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 10 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 9 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 8 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 7 generations backK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- 6 generations backK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- 5 generations backK180210 CREO® Stabilization SystemGlobus Medical, Inc. · 2018
- 4 generations backK182478 Whistler Modular Pedicle Screw SystemEvolution Spine, LLC · 2019
- 3 generations backK200922 Altus Spine HA Pedicle Screw SystemAltus Partners, LLC · 2021
- 2 generations backK211027 Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2022
- 1 generation backK230766 Altus Spine Monaco Pedicle Screw SystemAltus Spine · 2023
- This deviceK243419 Altus Spine Navigation SystemAltus Partners, LLC · 2025
Class I recalls in this family
- K100952 Modification to Synthes Matrix System7 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −20 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −19 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −18 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −17 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −16 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −15 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −14 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −13 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −12 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −11 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −10 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −9 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −8 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −7 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| −6 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| −5 | K180210 | CREO® Stabilization System | Globus Medical, Inc. | 2018 | — |
| −4 | K182478 | Whistler Modular Pedicle Screw System | Evolution Spine, LLC | 2019 | — |
| −3 | K200922 | Altus Spine HA Pedicle Screw System | Altus Partners, LLC | 2021 | — |
| −2 | K211027 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2022 | — |
| −1 | K230766 | Altus Spine Monaco Pedicle Screw System | Altus Spine | 2023 | — |
| 0 (this device) | K243419 | Altus Spine Navigation System | Altus Partners, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 16 | 0 |
| 1996 | 10 | 0 |
| 1997 | 15 | 0 |
| 1998 | 19 | 0 |
| 1999 | 16 | 0 |
| 2000 | 27 | 0 |
| 2001 | 26 | 0 |
| 2002 | 15 | 0 |
| 2003 | 17 | 0 |
| 2004 | 32 | 0 |
| 2005 | 29 | 0 |
| 2006 | 17 | 0 |
| 2007 | 13 | 0 |
| 2008 | 16 | 0 |
| 2009 | 14 | 0 |
| 2010 | 16 | 1 |
| 2011 | 12 | 0 |
| 2012 | 8 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 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.
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? (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 |
|---|---|---|---|
| * | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Summary page 5…ne Navigation System PRIMARY PREDICATE DEVICES: Medtronic Sofamor Danek, USA Inc., Navigated CD Horizon® Solera® Screwdrivers and Taps (K170679) ADDITIONAL PREDICATE DEVICES: Altus Spine Monaco Pedicle Screw System (K230766)… | 2017 |
| * | K230766 | Altus Spine Monaco Pedicle Screw SystemSummary page 5…ra® Screwdrivers and Taps (K170679) ADDITIONAL PREDICATE DEVICES: Altus Spine Monaco Pedicle Screw System (K230766) Altus Spine Valencia Pedicle Screw System (K181281) CLASSIFICATION & REGULATION #: Class II per 2… | 2023 |
| * | K181281 | Altus Spine Pedicle Screw SystemSummary page 5…ICATE DEVICES: Altus Spine Monaco Pedicle Screw System (K230766) Altus Spine Valencia Pedicle Screw System (K181281) CLASSIFICATION & REGULATION #: Class II per 21 CFR §888.4560 PRODUCT CODES: OLO DEVICE DESCRIPTION: T… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 7 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 40 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 33 of the 389 ancestors have a recall of any class; 1 has a Class I recall.
- 15 other devices also cite its predicate K170679.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Altus Spine Navigation System reusable instruments are indicated to be used during the preparation and placement of Altus Spine Valencia Pedicle Screw System and Altus Spine Monaco Pedicle Screw System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Altus Spine Navigation System reusable instruments are specifically designed for use with the Medtronic…
Read the full statement (227 words)
The Altus Spine Navigation System reusable instruments are indicated to be used during the preparation and placement of Altus Spine Valencia Pedicle Screw System and Altus Spine Monaco Pedicle Screw System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Altus Spine Navigation System reusable instruments are specifically designed for use with the Medtronic StealthStation® System S8, which is indicated for any medical condition 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 for the anatomy.
• For a comprehensive summary of indications, the IFU for the specific system of use must be directly referenced: Altus Spine Valencia Pedicle Screw System / Altus Spine Monaco Pedicle Screw System.
The Altus Spine Navigation System is intended to pair with either the Altus Spine Valencia Pedicle Screw System or Altus Spine Monaco Pedicle Screw system to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The Altus Spine Navigation system may be used for noncervical pedicle fixation via posterior percutaneous approach with MIS instrumentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243419: Altus Spine Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243419
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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