Cleared Traditional

K111995 - XINGTM SPINE SYSTEM

K111995 is an FDA 510(k) clearance for XINGTM SPINE SYSTEM, manufactured by Implanova Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K111995 · Implanova Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
152d
Days
Class 2
Risk

K111995 is an FDA 510(k) clearance for the XINGTM SPINE SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Implanova Co., Ltd. (Brea, US). The FDA issued a Cleared decision on December 12, 2011 after a review of 152 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 - K111995

510(k) Number K111995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2011
Decision Date December 12, 2011
Days to Decision 152 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
30d slower than avg
Panel avg: 122d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K111995.
DSS STABILIZATION SYSTEM-RIGID
K120491 · Paradigm Spine, LLC · May 2012
ARTS2 SPINAL FIXATION SYSTEM
K103573 · Advanced Medical Technologies · Dec 2011
LANCER PEDICLE SCREW SYSTEM
K110633 · Spinal Solutions, LLC · Dec 2011
DEVINE SPINAL SYSTEM
K111690 · Changzhou Orthmed Medical Instrument Co., Ltd. · Nov 2011
PASS LP SPINAL SYSTEM
K110497 · Medicrea International · Sep 2011
ODALYS PEDICLE SCREW SYSTEM
K111370 · Kalitec Direct, LLC · Sep 2011
K111995 · XINGTM SPINE SYSTEM
Download PDF FDA Summary Implanova Co., Ltd.