Cleared Traditional

K142655 - CB PROT II Posterior Spinal System

K142655 is an FDA 510(k) clearance for CB PROT II Posterior Spinal System, manufactured by Chin Bone Technique Corp. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K142655 · Chin Bone Technique Corp · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
130d
Days
Class 2
Risk

K142655 is an FDA 510(k) clearance for the CB PROT II Posterior Spinal System. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Chin Bone Technique Corp (Taipei, TW). The FDA issued a Cleared decision on January 26, 2015 after a review of 130 days - within the typical 510(k) review window.

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 - K142655

510(k) Number K142655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2014
Decision Date January 26, 2015
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
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 303
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K142655.
ANAX 5.5 Spinal System
K143417 · U&I Corporation · Feb 2015
PedFuse Pedicle Screw System
K143377 · Spinefrontier, Inc. · Feb 2015
Ideal pedicle screw spinal system
K142957 · Jiangsu Ideal Medical Science & Technology Co., Ltd. · Jan 2015
MAXIMIS SPINAL FIXATION SYSTEM
K140359 · Valorem Surgical · Jan 2015
KangLi pedical screw spinal system
K142290 · Suzhou Kangli Orthopaedics Instrument Co., Ltd. · Nov 2014
GENERAL SPINAL SYSTEM
K134011 · Changzhou Dean Medical Instrument Co, Ltd. · Sep 2014