Cleared Traditional

ORTHROS™ Posterior Stabilization System (K180980) - FDA 510(k) Clearance

Also marketed or referenced as:
ORTHROS™ MIS Posterior Stabilization System

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

K180980 · Camber Spine Technologies, LLC · Orthopedic device
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Oct 2018
Decision
197d
Days
Class 2
Risk

K180980 is an FDA 510(k) clearance for the ORTHROS™ Posterior Stabilization System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Camber Spine Technologies, LLC (Wayne, US). The FDA issued a Cleared decision on October 27, 2018 after a review of 197 days - an extended review 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: 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 Camber Spine Technologies, LLC devices

Submission Details

510(k) Number K180980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2018
Decision Date October 27, 2018
Days to Decision 197 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
75d slower than avg
Panel avg: 122d · This submission: 197d
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

RQMIS, Inc.
Manjusha Bharadwaj

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 K180980.
C-Zero Pedicle Screw System, Freedom Pedicle Screw System
K180754 · Signature Orthopaedics Pty, Ltd. · Dec 2018
PathLoc-L MIS Spinal System
K183117 · L & K Biomed Co., Ltd. · Nov 2018
VersaLink™ Fixation System
K182598 · Premia Spine, Ltd. · Nov 2018
FUSE Pedicle Screw System
K182283 · Black Box Medical · Oct 2018
OLYMPIC Posterior Spinal Fixation System
K182239 · Astura Medical, LLC · Oct 2018
PASS LP Spinal System
K182240 · Medicrea International SA · Oct 2018