Cleared Traditional

K150294 - DPZ Pedicular Fixation System

K150294 is an FDA 510(k) clearance for DPZ Pedicular Fixation System, manufactured by Osteomed Implantes, Ltda. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K150294 · Osteomed Implantes, Ltda · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
119d
Days
Class 2
Risk

K150294 is an FDA 510(k) clearance for the DPZ Pedicular Fixation System. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Osteomed Implantes, Ltda (Rio Claro - Sp, BR). The FDA issued a Cleared decision on June 5, 2015 after a review of 119 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 - K150294

510(k) Number K150294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2015
Decision Date June 05, 2015
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
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 Consultant

The OrthoMedix Group, Inc.
J. D. Webb

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 - MNI Orthosis, Spinal Pedicle Fixation

All 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K150294.
Reliance Spinal Screw System
K152131 · Reliance Medical Systems, LLC · Sep 2015
Sniper Spine System
K152174 · Spine Wave, Inc. · Aug 2015
Sniper Spine System
K151813 · Spine Wave, Inc. · Jul 2015
Polyscrew Pedicle Screw System
K150647 · New Era Orthopedics, LLC · Apr 2015
PASS LP Spinal System
K150049 · Medicrea International · Feb 2015
NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
K141253 · New Era Orthopaedics, LLC · Jan 2015