Cleared Traditional

K121786 - DYMAXEON SPINE SYSTEM

K121786 is an FDA 510(k) clearance for DYMAXEON SPINE SYSTEM, manufactured by B2b Spine Pty, Ltd.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K121786 · B2b Spine Pty, Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 2012
Decision
140d
Days
Class 2
Risk

K121786 is an FDA 510(k) clearance for the DYMAXEON SPINE SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by B2b Spine Pty, Ltd. (Washington, US). The FDA issued a Cleared decision on November 5, 2012 after a review of 140 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.

View all B2b Spine Pty, Ltd. devices

FDA 510(k) Submission Details - K121786

510(k) Number K121786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2012
Decision Date November 05, 2012
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

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 733
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K121786.
S4 SPINAL SYSTEM
K123352 · Aesculap Implant Systems, Inc. · Dec 2012
ES2 SPINAL SYSTEM MODEL 48280XXXX
K122845 · Stryker Spine · Dec 2012
CD HORIZON SPIRE Z SPINAL SYSTEM
K123246 · Medtronic Sofamor Danek · Nov 2012
TIGER SPINE SYSTEM
K121728 · Corelink, LLC · Oct 2012
CD HORIZON SPINAL SYSTEM
K122862 · Medtronic Sofamor Danek USA, Inc. · Oct 2012
TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM
K120891 · Ulrich GmbH & Co. KG · Oct 2012