Cleared Traditional

K131343 - REFORM PEDICLE SCREW SYSTEM

K131343 is an FDA 510(k) clearance for REFORM PEDICLE SCREW SYSTEM, manufactured by Spinal USA. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K131343 · Spinal USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
76d
Days
Class 2
Risk

K131343 is an FDA 510(k) clearance for the REFORM PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Spinal USA (Colorado Springs, US). The FDA issued a Cleared decision on July 24, 2013 after a review of 76 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 Spinal USA devices

FDA 510(k) Submission Details - K131343

510(k) Number K131343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2013
Decision Date July 24, 2013
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 184
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K131343.
EVEREST SPINAL SYSTEM
K132361 · K2m, Inc. · Oct 2013
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
K132644 · Corentec Co., Ltd. · Sep 2013
CAPSURE PS SYSTEM
K132154 · Spine Wave, Inc. · Aug 2013
REFORM PEDICLE SCREW SYSTEM
K130279 · Spinal USA · Jun 2013
RELIANCE SPINAL SCREW SYSTEM
K123521 · Reliance Medical Systems, LLC · Feb 2013
S-LOK PSS SYSTEM
K122931 · Spinal USA · Nov 2012