Cleared Traditional

K170861 - Premier

K170861 is an FDA 510(k) clearance for Premier, manufactured by Shandong Weigao Orthopaedic Device Co., Ltd.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K170861 · Shandong Weigao Orthopaedic Device Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
134d
Days
Class 2
Risk

K170861 is an FDA 510(k) clearance for the Premier. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Shandong Weigao Orthopaedic Device Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on August 4, 2017 after a review of 134 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.

FDA 510(k) Submission Details - K170861

510(k) Number K170861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2017
Decision Date August 04, 2017
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
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 Consultant

Musculoskeletal Clinical Regulatory Advisers, LLC
Justin Eggleton

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 913
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K170861.
Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System
K172107 · Spineology, Inc. · Aug 2017
CapSure® PS System
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Paonan Armstrong Posterior Spinal Fixation System
K161225 · Paonan Biotech Co., Ltd. · Aug 2017
Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
K171456 · Choicespine · Aug 2017
M.U.S.T. Combined Set Screws
K171758 · Medacta International S.A. · Aug 2017
True Spinal Fixation System
K171559 · Innovative Surgical Designs, Inc. · Jul 2017