Cleared Special

K143377 - PedFuse Pedicle Screw System

K143377 is an FDA 510(k) clearance for PedFuse Pedicle Screw System, manufactured by Spinefrontier, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 79-day FDA review.

K143377 · Spinefrontier, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
79d
Days
Class 2
Risk

K143377 is an FDA 510(k) clearance for the PedFuse Pedicle Screw System. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Spinefrontier, Inc. (Beverly, US). The FDA issued a Cleared decision on February 12, 2015 after a review of 79 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spinefrontier, Inc. devices

FDA 510(k) Submission Details - K143377

510(k) Number K143377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2014
Decision Date February 12, 2015
Days to Decision 79 days
Submission Type Special
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
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Empirical Testing Corp
Kenneth C Maxwell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 231
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K143377.
Romeo posterior osteosynthesis system
K151695 · Spineart · Sep 2015
PASS LP Spinal System
K142798 · Medicrea International SA · Mar 2015
ANAX 5.5 Spinal System
K143417 · U&I Corporation · Feb 2015
MAXIMIS SPINAL FIXATION SYSTEM
K140359 · Valorem Surgical · Jan 2015
GENERAL SPINAL SYSTEM
K134011 · Changzhou Dean Medical Instrument Co, Ltd. · Sep 2014
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM
K133575 · Spinevision S.A. · Jun 2014