Cleared Traditional

K131292 - DEROYAL SPINE SPACER SYSTEM

K131292 is the FDA 510(k) clearance for DEROYAL SPINE SPACER SYSTEM by Deroyal Industries, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K131292 · Deroyal Industries, Inc. · Orthopedic device
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Feb 2014
Decision
273d
Days
Class 2
Risk

K131292 is an FDA 510(k) clearance for the DEROYAL SPINE SPACER 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 Deroyal Industries, Inc. (Chesterland, US). The FDA issued a Cleared decision on February 3, 2014 after a review of 273 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 Deroyal Industries, Inc. devices

Submission Details

510(k) Number K131292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2013
Decision Date February 03, 2014
Days to Decision 273 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
151d slower than avg
Panel avg: 122d · This submission: 273d
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 609
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K131292.
ABACUS TM SPACER SYSTEM
K140007 · Spine Wave, Inc. · Apr 2014
ALEUTIAN IBF SYSTEM
K133614 · K2m, Inc. · Apr 2014
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
K133205 · Medtronic Sofamor Danek USA, Inc. · Mar 2014
JULIET LL LATERAL LUMBAR CAGE
K133557 · Spineart · Feb 2014
ARDIS INTERBODY SYSTEM
K133184 · Zimmer Spine, Inc. · Jan 2014
MECTALIF TIPEEK
K133192 · Medacta International · Jan 2014