Cleared Traditional

EDEN Peek Cage (K201793) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201793 · Jmt Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
440d
Days
Class 2
Risk

K201793 is an FDA 510(k) clearance for the EDEN Peek Cage. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Jmt Co., Ltd. (Yangju-Si, KR). The FDA issued a Cleared decision on September 13, 2021 after a review of 440 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 Jmt Co., Ltd. devices

Submission Details

510(k) Number K201793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2020
Decision Date September 13, 2021
Days to Decision 440 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
318d slower than avg
Panel avg: 122d · This submission: 440d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, 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.
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 Consultant

LK Consulting Group USA, Inc.
Priscilla Chung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 182
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K201793.
CHENA-C Spacer System
K213115 · Kahtnu Surgical, Inc. · Dec 2021
ORIO-Ti Intervertebral Body Fusion Cage System
K211935 · Spinecraft, LLC · Sep 2021
Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
K212792 · Medynus, Inc. · Sep 2021
CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System
K211704 · Orthofix, Inc. · Aug 2021
K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
K212038 · K&J Consulting Corporation · Aug 2021
Advantage-C PEEK Cervical lnterbody Fusion Device
K211501 · Lntelivation, LLC · Aug 2021