FDA.reportPublic FDA data

510(k) K243565

Device
DYNAMIS? SI Screw System
Applicant
Promethean Restorative, LLC
510(k) number
K243565
Product code
OUR
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-28
Date received
2024-11-18
Regulation
888.3040
Classification name
Sacroiliac Joint Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Glenn Bowman
Address
333 Perry St., Suite 210 Castle Rock CO US 80104 80104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OUR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical2026-04-08
K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.2026-02-11
K253611Falco Fusion SystemMcnicoll Surgical, Inc.2026-01-29
K252834Sacroiliac Joint Truss System (SJTS)4Web Medical2026-01-28
K251365OptumSI Implant SystemSi Solutions, LLC2025-11-20
K252322SIros-X SystemGenesys Spine2025-10-22
K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.2025-10-09
K250894Eminent Spine Posterior SI SystemEminent Spine2025-10-07
K250647SImmetry+ SystemSivantage2025-07-29
K250247panaSIa SI Fusion SystemWenzel Spine, Inc.2025-07-09
K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.2025-06-26
K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC2025-06-06
K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC2025-06-06
K250001Patriot SI Implant SystemSpinal Simplicity, LLC2025-06-03
K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC2025-04-25