Cleared Traditional

K193472 - OrthoCircle Spine Pedicle Screw System

K193472 is the FDA 510(k) clearance for OrthoCircle Spine Pedicle Screw System by Orthocircle Spine. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K193472 · Orthocircle Spine · Orthopedic device
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Feb 2020
Decision
59d
Days
Class 2
Risk

K193472 is an FDA 510(k) clearance for the OrthoCircle Spine Pedicle Screw System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Orthocircle Spine (Savannah, US). The FDA issued a Cleared decision on February 13, 2020 after a review of 59 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 Orthocircle Spine devices

Submission Details

510(k) Number K193472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2019
Decision Date February 13, 2020
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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
Nathan Wright

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 - NKB Thoracolumbosacral Pedicle Screw System

All 614
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K193472.
MEGAFIX® Pedicle Screw Spinal System
K191655 · Seohancare Co., Ltd. · Mar 2020
LOSPA® IS™ Spinal Fixation System
K200267 · Corentec Co., Ltd. · Mar 2020
Daytona® Small Stature Spinal System
K200381 · SeaSpine Orthopedics Corporation · Feb 2020
PERLA® TL posterior osteosynthesis system
K193396 · Spineart · Feb 2020
CapLOX II®/TowerLOX® MIS Pedicle Screw System
K193270 · Captiva Spine, Inc. · Jan 2020
M.U.S.T. Pedicle Screw System
K193365 · Medacta International S.A. · Jan 2020