510(k) · Cleared
ClearedCarboClear Navigated Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CarboFix Orthopedics, Ltd. · OLO Orthopedic Stereotaxic Instrument
Cleared on Aug 5, 2020 as substantially equivalent to K153442 (Medtronic Sofamor Danek USA, Inc., 2016) and 6 other predicates after an 86-day review. Its family tree reaches back 17 generations to 2004. 9 later devices descend from it.
- Decided
- Aug 5, 2020
- Review
- 86 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 17 generations to K040583 (2004). 352 ancestors in all, the oldest K841189 (1984). 9 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations between
- 3 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 2 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- This deviceK201251 CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2020
- Descendant · cites it directly · 8 of its ownK210716 CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2021
- Descendant · 2 generations on · 4 of its ownK231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2023
- Descendant · 2 generations on · 3 of its ownK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
- Descendant · 2 generations on · 2 of its ownK240846 CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2024
- Descendant · 2 generations on · 2 of its ownK233989 CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd. · 2024
Show all 17 generations
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 5 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 4 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 3 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 2 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- This deviceK201251 CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2021 · cites it directly8descendants
- K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd. · 2023 · 2 generations on4descendants
- K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2024 · 2 generations on3descendants
- K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd. · 2024 · 2 generations on2descendants
- K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd. · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −14 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −12 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −9 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −8 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −7 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −6 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −5 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −4 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −3 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −2 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K153203 | Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| 0 (this device) | K201251 | CarboClear Navigated Instruments | CarboFix Orthopedics, Ltd. | 2020 | — |
| +1 | K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | CarboFix Orthopedics, Ltd. | 2021 | — |
| +2 | K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments… | CarboFix Orthopedics, Ltd. | 2023 | — |
| +2 | K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | CarboFix Orthopedics, Ltd. | 2024 | — |
| +2 | K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated… | CarboFix Orthopedics, Ltd. | 2024 | — |
| +2 | K233989 | CarboClear® Posterior Cervical Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 7 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 13 | 0 |
| 1996 | 10 | 0 |
| 1997 | 11 | 0 |
| 1998 | 17 | 0 |
| 1999 | 19 | 0 |
| 2000 | 19 | 0 |
| 2001 | 24 | 0 |
| 2002 | 21 | 0 |
| 2003 | 21 | 0 |
| 2004 | 32 | 0 |
| 2005 | 26 | 0 |
| 2006 | 17 | 0 |
| 2007 | 14 | 0 |
| 2008 | 16 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
Planning a device in OLO? 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? (7)
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 |
|---|---|---|---|
| * | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Summary page 5…of 3 CARBOFIX ORTHOPEDICS LTD. CARBOCLEAR® NAVIGATED INSTRUMENTS Predicate Devices Primary Predicate: Medtronic Navigated Instruments (Medtronic Sofamor Danek; K153442) Additional Predicates: Medtronic Navigated Instruments (Medtronic Sofamor Danek; K124004, K140454, K143375) … | 2016 |
| * | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsSummary page 5…dicate: Medtronic Navigated Instruments (Medtronic Sofamor Danek; K153442) Additional Predicates: Medtronic Navigated Instruments (Medtronic Sofamor Danek; K124004, K140454, K143375) Globus Navigation Instruments (Globus Medical, Inc.; K153203) CarboClear® Pedicle Screw Syst… | 2013 |
| * | K140454 | Navigated CD Horizon Solera Screwdriver/TapsSummary page 5… Medtronic Navigated Instruments (Medtronic Sofamor Danek; K153442) Additional Predicates: Medtronic Navigated Instruments (Medtronic Sofamor Danek; K124004, K140454, K143375) Globus Navigation Instruments (Globus Medical, Inc.; K153203) CarboClear® Pedicle Screw System Instru… | 2014 |
| * | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsSummary page 5…Navigated Instruments (Medtronic Sofamor Danek; K153442) Additional Predicates: Medtronic Navigated Instruments (Medtronic Sofamor Danek; K124004, K140454, K143375) Globus Navigation Instruments (Globus Medical, Inc.; K153203) CarboClear® Pedicle Screw System Instruments (CarboFix… | 2015 |
| * | K153203 | Navigation InstrumentsSummary page 5…l Predicates: Medtronic Navigated Instruments (Medtronic Sofamor Danek; K124004, K140454, K143375) Globus Navigation Instruments (Globus Medical, Inc.; K153203) CarboClear® Pedicle Screw System Instruments (CarboFix Orthopedics, Ltd.; K173487, K182377) Indications for Use Ca… | 2016 |
| * | K173487 | CarboClear® Pedicle Screw SystemSummary page 5…K143375) Globus Navigation Instruments (Globus Medical, Inc.; K153203) CarboClear® Pedicle Screw System Instruments (CarboFix Orthopedics, Ltd.; K173487, K182377) Indications for Use CarboClear® Navigated Instruments are intended to be used during the preparation and placement of… | 2018 |
| * | K182377 | CarboClear® Pedicle Screw SystemSummary page 5…43375) Globus Navigation Instruments (Globus Medical, Inc.; K153203) CarboClear® Pedicle Screw System Instruments (CarboFix Orthopedics, Ltd.; K173487, K182377) Indications for Use CarboClear® Navigated Instruments are intended to be used during the preparation and placement of CarboCle… | 2018 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | 2021 | 8 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 40 of the 352 ancestors have a recall of any class.
- Of its descendants, K210716 (CarboFix Orthopedics, Ltd., 2021) has gone furthest, with 8 descendants of its own.
- 12 other devices also cite its predicate K153442.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
CarboClear® Navigated Instruments are intended to be used during the preparation and placement of CarboClear® Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® Navigated Instruments are designed for use with the Medtronic StealthStation® System, 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201251: CarboClear Navigated Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201251
Report an extraction error
Are you the manufacturer?
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