Cleared Traditional

MOSS VRS Spinal System (K181821) - FDA 510(k) Clearance

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

K181821 · Biedermann Motech GmbH & Co. KG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
66d
Days
Class 2
Risk

K181821 is an FDA 510(k) clearance for the MOSS VRS Spinal System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Biedermann Motech GmbH & Co. KG (Villingen-Schwenningen, DE). The FDA issued a Cleared decision on September 13, 2018 after a review of 66 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 Biedermann Motech GmbH & Co. KG devices

Submission Details

510(k) Number K181821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2018
Decision Date September 13, 2018
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
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 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 K181821.
OsseoScrew System
K181980 · Alphatec Spine, Inc. · Sep 2018
Chiral Surgical Pedicle Screw System
K181995 · Chiral Surgical · Sep 2018
Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
K181390 · OrthoPediatrics Corp. · Sep 2018
CD HORIZON™ Spinal System
K182119 · Medtronic Sofamor Danek USA, Inc. · Aug 2018
Firebird® Spinal Fixation Systems: Firebird System
K180179 · Orthofix, Inc. · Aug 2018
Zenius™, Iliad™ and Kora™ Spinal Fixation Systems
K181978 · Medyssey USA, Inc. · Aug 2018