# K242464: Stealth™ Spine Clamps; ModuLeX™ Shank Mounts

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Jun 5, 2025 after 290 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K841189 (1984). 95 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211442: StealthStation Spinous Process Clamps, Medtronic Navigation (2021) Summary page 5.
- K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter, Medtronic Navigation, Inc. (2013) Summary page 5.

## Most influential descendants
- K254165: Infinity™ OCT System (2026), 0 descendants of its own

## Indications for use
Stealth™ Spine Clamps When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable: • The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. • The navigated instruments are specifically designed for use with Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. • The Stealth™ spine clamps are indicated for skeletally mature patients. ModuLeX™ Shank Mounts When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable: • The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. • The navigated instruments are specifically designed for use with Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. • The ModuLeX™ shank mounts are indicated to be used with the CD Horizon™ ModuLeX™ Spinal System during surgery. • The ModuLeX™ shank mounts are indicated for skeletally mature patients.

Source page: https://510kreport.com/device/K242464
Methodology: https://510kreport.com/methodology