Cleared Traditional

K140229 - GENERAL SPINAL SYSTEM

K140229 is an FDA 510(k) clearance for GENERAL SPINAL SYSTEM, manufactured by Tianjin Walkman Biomaterial Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K140229 · Tianjin Walkman Biomaterial Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
89d
Days
Class 2
Risk

K140229 is an FDA 510(k) clearance for the GENERAL SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Tianjin Walkman Biomaterial Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 29, 2014 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tianjin Walkman Biomaterial Co., Ltd. devices

FDA 510(k) Submission Details - K140229

510(k) Number K140229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2014
Decision Date April 29, 2014
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 194
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K140229.
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS
K141835 · Spineart · Sep 2014
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
K141397 · Precision Spine, Inc. · Jun 2014
MYSPINE PEDICLE SCREW PLACEMENT GUIDES
K132788 · Medacta International · May 2014
EVEREST SPINAL SYSTEM
K132757 · K2m, Inc. · Nov 2013
INERTIA MIS PEDICLE SCREW SYSTEM
K132412 · Nexxt Spine, LLC · Oct 2013
EVEREST SPINAL SYSTEM
K132361 · K2m, Inc. · Oct 2013