Cleared Traditional

K251431 - FIX-C PEEK ACIF SA System

K251431 is the FDA 510(k) clearance for FIX-C PEEK ACIF SA System by Jeil Medical Corporation. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K251431 · Jeil Medical Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
50d
Days
Class 2
Risk

K251431 is an FDA 510(k) clearance for the FIX-C PEEK ACIF SA System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on June 27, 2025 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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.

View all Jeil Medical Corporation devices

Submission Details

510(k) Number K251431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2025
Decision Date June 27, 2025
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 112
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K251431.
Endeavor™ Stand-Alone Cervical IBF System
K250076 · Innovasis · Sep 2025
SABER-C System
K250540 · Elevation Spine · Aug 2025
Stabilis SA Cervical Stand-Alone System (Various PNs)
K251735 · Acuity Surgical Devices, LLC · Jul 2025
Cervical Spine Truss System (CSTS)
K251117 · 4Web Medical · Apr 2025
Tesera-k SC System
K242928 · Kyocera Medical Technologies, Inc. · Apr 2025
CYLOX® ST
K243188 · Signus Medizintechnik GmbH · Feb 2025