Cleared Traditional

K112388 - LANX CERVICAL SA

K112388 is an FDA 510(k) clearance for LANX CERVICAL SA, manufactured by Lanx, Inc.. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K112388 · Lanx, Inc. · Orthopedic device
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Dec 2011
Decision
120d
Days
Class 2
Risk

K112388 is an FDA 510(k) clearance for the LANX CERVICAL SA. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Lanx, Inc. (Broomfield, US). The FDA issued a Cleared decision on December 16, 2011 after a review of 120 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 Lanx, Inc. devices

FDA 510(k) Submission Details - K112388

510(k) Number K112388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2011
Decision Date December 16, 2011
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVE Device Classification - Class 2, Special Controls

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 124
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K112388.
SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K122771 · Spinal Elements, Inc. · Jan 2013
PRO-LINK CERVICAL SPACER SYSTEM
K121151 · Life Spine, Inc. · Nov 2012
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K113252 · Medtronic Sofamor Danek · Jan 2012
CHESAPEAKE (CERVICAL COMPONENTS)
K111439 · K2m, Inc. · Aug 2011
AVS ANCHOR-C CERVICAL CAGE SYSTEM
K102606 · Stryker Spine · Apr 2011
COROENT INTERLOCK SYSTEM
K102547 · Nuvasive, Inc. · Feb 2011