# K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Aug 14, 2013 after 89 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K841189 (1984). 93 ancestors in all.
246 later devices descend from it; 8 cite it directly.
1 of 340 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps, Medtronic Navigation, Inc. (2013) Summary page 2.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 2.
- K103731: Capstone R Spinal System, Medtronic Sofamor Danek (2011) Summary page 2.
- K083026: Clydesdale Spinal System, Medtronic Sofamor Danek (2008) Summary page 2.
- K112405: Clydesdales Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 3.

## Most influential descendants
- K150231: Navigated Disc Prep Instruments and CAPSTONE Trials (2015), 242 descendants of its own
- K163581: Navigated ELEVATE Inserter, Navigated Disc Prep Instruments (2017), 103 descendants of its own
- K153442: CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems (2016), 84 descendants of its own
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems (2016), 79 descendants of its own
- K210425: Catalyft PL Expandable Interbody System (2021), 56 descendants of its own

## Recalls of this device
- Dec 4, 2024 · Class II · Z-1022-2025: Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
- Nov 28, 2023 · Class II · Z-0699-2024: Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
- Nov 28, 2023 · Class II · Z-0698-2024: Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
- Dec 6, 2018 · Class II · Z-0707-2020: Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connec
- Jun 29, 2017 · Class II · Z-3142-2017: Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body followi
- Jun 29, 2017 · Class II · Z-3140-2017: Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body followi
- Jun 29, 2017 · Class II · Z-3141-2017: Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body followi
- Jun 29, 2017 · Class II · Z-3143-2017: Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body followi
- Jun 29, 2017 · Class II · Z-3139-2017: Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body followi
- Jul 18, 2016 · Class II · Z-2316-2016: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

## Indications for use
The Navigated Inserter is intended to be use during implant placement of Medtronic intervertebral body fusion devices during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. The navigated instruments are specifically designed for use with the 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Source page: https://510kreport.com/device/K131425
Methodology: https://510kreport.com/methodology