510(k) · Cleared
ClearedKalitec Navigated Instrument System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kalitec Direct, LLC Doing Business AS Kalitec Medical · OLO Orthopedic Stereotaxic Instrument
Cleared on Dec 13, 2023 as substantially equivalent to K124004 (Medtronic Navigation, Inc., 2013) and 3 other predicates after a 111-day review. Its family tree reaches back 10 generations to 1986.
- Decided
- Dec 13, 2023
- Review
- 111 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K862807 (1986). 174 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 10 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 6 generations between
- 3 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 2 generations backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 1 generation backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- This deviceK232572 Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical · 2023
Show all 10 generations
- Root · 10 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 9 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 8 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 7 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 6 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 5 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 4 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 3 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 2 generations backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 1 generation backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- This deviceK232572 Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −9 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −8 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −7 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −6 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −5 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −4 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −3 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −2 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −1 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| 0 (this device) | K232572 | Kalitec Navigated Instrument System | Kalitec Direct, LLC Doing Business AS Kalitec Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 7 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 12 | 0 |
| 1996 | 6 | 0 |
| 1997 | 7 | 0 |
| 1998 | 9 | 0 |
| 1999 | 6 | 0 |
| 2000 | 17 | 0 |
| 2001 | 10 | 0 |
| 2002 | 6 | 0 |
| 2003 | 11 | 0 |
| 2004 | 9 | 0 |
| 2005 | 12 | 0 |
| 2006 | 11 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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? (4)
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 |
|---|---|---|---|
| * | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsSummary page 4…er 882.4560 Product Code OoLO I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K124004/K140454/ Medtronic Navigated CD Horizon Solera Screwdrivers and Taps | | OLO K140678/K172808 Cosmolock Pedicle Screw System MNI… | 2013 |
| * | K140454 | Navigated CD Horizon Solera Screwdriver/TapsSummary page 4…560 Product Code OoLO I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K124004/K140454/ Medtronic Navigated CD Horizon Solera Screwdrivers and Taps | | OLO K140678/K172808 Cosmolock Pedicle Screw System MNI Device… | 2014 |
| * | K140678 | Cosmolock Pedicle Screw SystemSummary page 4…Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K124004/K140454/ Medtronic Navigated CD Horizon Solera Screwdrivers and Taps | | OLO K140678/K172808 Cosmolock Pedicle Screw System MNI Device Description Summary 21 CFR 807.92(a)(4) The Kalitec Navigated Instrument Syst… | 2014 |
| * | K172808 | CosmoLock Pedicle Screw SystemSummary page 4…te # Predicate Trade Name (Primary Predicate is listed first) Product Code K124004/K140454/ Medtronic Navigated CD Horizon Solera Screwdrivers and Taps | | OLO K140678/K172808 Cosmolock Pedicle Screw System MNI Device Description Summary 21 CFR 807.92(a)(4) The Kalitec Navigated Instrument System is co… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 23 of the 174 ancestors have a recall of any class.
- 14 other devices also cite its predicate K124004.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalitec Navigated Instruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are indicated for any medical condition in which the use of…
Read the full statement (119 words)
The Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalitec Navigated Instruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are 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. Use of the Kalitec Navigated Instrument System instruments is limited to use only with Kalitec pedicle screw systems.
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/K232572 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232572: Kalitec Navigated Instrument System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232572
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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