# K130887: S4C Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant System, Inc.
- Decided: Aug 13, 2013 after 137 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: 11 generations back to K853033 (1985). 46 ancestors in all.
13 later devices descend from it; 2 cite it directly.
1 of 60 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053159: Vectorvision Spine, Brainlab AG (2006) Summary page 2.
- K042721: Kolibri Spine, Brainlab AG (2005) Summary page 2.
- K062358: Modification to Vectorvision Trauma, Brainlab AG (2007) Summary page 2.
- K070106: VV Fluoro 3D, Brainlab AG (2007) Summary page 2.
- K083310: Spine & Trauma Ict, Brainlab AG (2009) Summary page 2.
- K110204: Brainlab Trauma, Brainlab AG (2011) Summary page 2.
- K060152: Modification to S4 Spinal System, Aesculap, Inc. (2006) Summary page 2.
- K062327: Modification to S4 Spinal System, Aesculap, Inc. (2007) Summary page 2.

## Cited in the summary but kept off the family tree
- K100204: Sonalis, Smith Associates (2010). Our reading of the summary gave K100204, FDA’s number for Sonalis (Smith Associates). Its FDA name has none of the distinctive words the summary uses for the device it names, “BrainLab Trauma”. Kept off the family tree. Summary page 2.
- K050797: Tissu-Trans, Shippert Medical Technologies Corp. (2005). Our reading of the summary gave K050797, FDA’s number for Tissu-Trans (Shippert Medical Technologies Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Aesculap S4C Spinal System”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K181890: Brainlab Compatible K2M Navigation Instruments (2018), 11 descendants of its own
- K192911: Brainlab Compatible K2M Navigation Instruments (2019), 9 descendants of its own
- K203205: Navigated Spine Instruments (2021), 8 descendants of its own
- K240662: Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece (2024), 7 descendants of its own
- K241171: Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories (2024), 4 descendants of its own

## Indications for use
The Aesculap S4 Cervical Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. They are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion during the navigation of pedicle screws (T1-T3).

Source page: https://510kreport.com/device/K130887
Methodology: https://510kreport.com/methodology