Cleared Traditional

K094025 - CRESCENT SPINAL SYSTEM

K094025 is an FDA 510(k) clearance for CRESCENT SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K094025 · Medtronic Sofamor Danek · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
117d
Days
Class 2
Risk

K094025 is an FDA 510(k) clearance for the CRESCENT SPINAL 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 Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on April 26, 2010 after a review of 117 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K094025

510(k) Number K094025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2009
Decision Date April 26, 2010
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

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 898
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K094025.
IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF
K083798 · Medicrea Technologies · May 2010
SYNTHES T-PAL SPACER
K100089 · Synthes Spine · May 2010
EPICAGE INTERBODY FUSION DEVICE
K092901 · R Tree Innovations · Apr 2010
SEC IBF CAGE
K093669 · Innvotec Surgical, Inc. · Mar 2010
AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX
K093864 · Stryker Corp. · Mar 2010
BINDER INTERVERTEBRAL BODY FUSION DEVICE
K093015 · Binder Biomedical, Inc. · Feb 2010
K094025 · CRESCENT SPINAL SYSTEM
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