Manufacturer
Promethean Restorative, LLCDYNAMIS™ Navigation System
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K252962
- Device name
- DYNAMIS™ Navigation System
- Company
- Promethean Restorative, LLC
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2025-09-16
- Decision date
- 2026-01-12
- Submission type
- Traditional
- Technology type
- Image Guided Surgery(AI inferred)
- Clinical applications
- Spine SurgeryNavigation SystemOther
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
The DYNAMIS™ Navigation System is intended to be used in the preparation and placement of the DYNAMIS™ Implant System during sacroiliac joint fusion surgery and fracture fixation of the pelvis to assist the surgeon in guiding instrument placement and implant positioning, in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis, or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image based model of the anatomy. The DYNAMIS™ Navigation System is intended to be used with the Medtronic StealthStation S8 System, Software Version 2.1.
Intended Use
The DYNAMIS™ Navigation System is intended to be used in the preparation and placement of the DYNAMIS™ Implant System during sacroiliac joint fusion surgery and fracture fixation of the pelvis to assist the surgeon in guiding instrument placement and implant positioning, in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis, or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image based model of the anatomy. The DYNAMIS™ Navigation System is intended to be used with the Medtronic StealthStation S8 System, Software Version 2.1.
Device Description
The DYNAMIS™ Navigation System consists of non-sterile, reusable, manual surgical instruments for use with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The DYNAMIS™ Navigation System includes drivers, taps, and awls which are used with the DYNAMIS™ Implant System. All instruments are made of stainless steel per ASTM F899. The DYNAMIS™ Navigation System instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation® System S8 and the Medtronic NavLock® Tracker System.
Summary parsed at:2026-06-19 04:30:16 UTC
Predicate devices
5Cited as predicate
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