Cleared Traditional

Goblin and Goblin LS Pedicle Screw Systems (K210420) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210420 · Medynus, Inc. · Orthopedic device
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Apr 2021
Decision
67d
Days
Class 2
Risk

K210420 is an FDA 510(k) clearance for the Goblin and Goblin LS Pedicle Screw Systems. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Medynus, Inc. (Irvine, US). The FDA issued a Cleared decision on April 19, 2021 after a review of 67 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 Medynus, Inc. devices

Submission Details

510(k) Number K210420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2021
Decision Date April 19, 2021
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
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

Eerkie Corporation
Jeena Mathai

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 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K210420.
CD Horizon™ Spinal System
K210637 · Medtronic · Apr 2021
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K210549 · Life Spine, Inc. · Apr 2021
M.U.S.T. Midline Cortical (MC) Screw System
K210427 · Medacta International S.A. · Apr 2021
CoreLink Midline Fixation System
K210539 · Corelink, LLC · Apr 2021
Auxein Brand Vertaux 5.5 mm Pedicle Screw System
K201457 · Auxein Medical Private Limited/71164 · Apr 2021
CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
K210716 · CarboFix Orthopedics , Ltd. · Apr 2021