Cleared Traditional

K112801 - AYERS ROCK CERVICAL CAGE

K112801 is an FDA 510(k) clearance for AYERS ROCK CERVICAL CAGE, manufactured by Qualgenix. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K112801 · Qualgenix · Orthopedic device
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May 2012
Decision
217d
Days
Class 2
Risk

K112801 is an FDA 510(k) clearance for the AYERS ROCK CERVICAL CAGE. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Qualgenix (Oxford, US). The FDA issued a Cleared decision on May 1, 2012 after a review of 217 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 Qualgenix devices

FDA 510(k) Submission Details - K112801

510(k) Number K112801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2011
Decision Date May 01, 2012
Days to Decision 217 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 122d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

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 Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 263
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K112801.
HONOUR SPACER SYSTEM
K120345 · Nexxt Spine, LLC · Jun 2012
LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120840 · L & K Biomed Co., Ltd. · May 2012
RELIANCE CERVICAL IBF SYSTEM
K120396 · Reliance Medical Systems, LLC · May 2012
DEPUY PULSE CERVICAL CAGE SYSTEM
K120517 · Medos International SARL · Apr 2012
ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K113518 · Spinefrontier, Inc. · Feb 2012
MECTA-C
K112862 · Medacta International · Dec 2011