510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243565Substantially Equivalent

DYNAMIS™ SI Screw System

Promethean Restorative Inc., Castle Rock CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243565 is the FDA 510(k) clearance record for DYNAMIS™ SI Screw System, a class II device, cleared for Promethean Restorative, LLC on under FDA product code OUR (Sacroiliac Joint Fixation). FDA's definition for product code OUR reads: "sacroiliac joint fusion". FDA records list 3 510(k) clearances for Promethean Restorative, LLC, from to . As of , FDA records show no recalls naming K243565.

Clearance record

Decision date
Received
(102 days to decision)
Product code
OUR Sacroiliac Joint Fixation
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Promethean Restorative, LLC 333 Perry St., Suite 210, Castle Rock CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUR

Trailing 12 months
6 clearances under product code OUR in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OUR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20262
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260