Cleared Traditional

K112036 - CALIX PC SPINAL IMPLANT SYSTEM

K112036 is an FDA 510(k) clearance for CALIX PC SPINAL IMPLANT SYSTEM, manufactured by X-Spine Systems, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K112036 · X-Spine Systems, Inc. · Orthopedic device
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Nov 2011
Decision
113d
Days
Class 2
Risk

K112036 is an FDA 510(k) clearance for the CALIX PC SPINAL IMPLANT SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by X-Spine Systems, Inc. (Miamisburg, US). The FDA issued a Cleared decision on November 8, 2011 after a review of 113 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.

View all X-Spine Systems, Inc. devices

FDA 510(k) Submission Details - K112036

510(k) Number K112036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2011
Decision Date November 08, 2011
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
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 242
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K112036.
ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K113518 · Spinefrontier, Inc. · Feb 2012
MECTA-C
K112862 · Medacta International · Dec 2011
TRABECULAR METAL (TM) FUSION DEVICE
K111119 · Zimmer Spine, Inc. · Nov 2011
PERIMETER C SPINAL SYSTEM
K100967 · Medtronic Sofamor Danek USA, Inc. · Aug 2011
VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
K111675 · Theken Spine, LLC · Aug 2011
PLATEAU SPACER SYSTEM
K111835 · Life Spine, Inc. · Jul 2011