Cleared Traditional

K180347 - 3d Cage

K180347 is the FDA 510(k) clearance for 3d Cage by Fims Co., Ltd.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 627-day FDA review.

K180347 · Fims Co., Ltd. · Orthopedic device
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Oct 2019
Decision
627d
Days
Class 2
Risk

K180347 is an FDA 510(k) clearance for the 3d Cage. 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 Fims Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on October 28, 2019 after a review of 627 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Fims Co., Ltd. devices

Submission Details

510(k) Number K180347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2018
Decision Date October 28, 2019
Days to Decision 627 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
505d slower than avg
Panel avg: 122d · This submission: 627d
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 K180347.
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K191791 · Trans1 · Sep 2019