Cleared Traditional

K262522 - Odys-SI Screw

K262522 is an FDA 510(k) clearance for Odys-SI Screw, manufactured by Medyssey Co, Ltd.. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K262522 · Medyssey Co, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
85d
Days
Class 2
Risk

K262522 is an FDA 510(k) clearance for the Odys-SI Screw. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Medyssey Co, Ltd. (Jecheon-Si, KR). The FDA issued a Cleared decision on October 15, 2026 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262522

510(k) Number K262522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2026
Decision Date October 15, 2026
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OUR Device Classification - Class 2, Special Controls

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 132
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K262522.
TiLink-L™ SI Joint Fusion System
K261381 · SurGenTec, LLC · Aug 2026
CATAMARAN™ SI Joint Fusion System
K260477 · Tenon Medical · Apr 2026
iFuse INTRA Ti™ Implant System
K253488 · SI-BONE, Inc. · Feb 2026
Falco Fusion System
K253611 · Mcnicoll Surgical, Inc. · Jan 2026
Sacroiliac Joint Truss System (SJTS)
K252834 · 4Web Medical · Jan 2026
OptumSI Implant System
K251365 · Si Solutions, LLC · Nov 2025
K262522 · Odys-SI Screw
Download PDF FDA Summary Medyssey Co, Ltd.