Cleared Traditional

K243973 - FIX-L PEEK PLIF and T-PLIF System

K243973 is the FDA 510(k) clearance for FIX-L PEEK PLIF and T-PLIF System by Jeil Medical Corporation. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K243973 · Jeil Medical Corporation · Orthopedic device
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Jun 2025
Decision
171d
Days
Class 2
Risk

K243973 is an FDA 510(k) clearance for the FIX-L PEEK PLIF and T-PLIF System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on June 12, 2025 after a review of 171 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Jeil Medical Corporation devices

Submission Details

510(k) Number K243973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2024
Decision Date June 12, 2025
Days to Decision 171 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
49d slower than avg
Panel avg: 122d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 595
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K243973.
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