Cleared Traditional

K170821 - ChoiceSpine Proliant Posterior Pedicle ...

K170821 is the FDA 510(k) clearance for ChoiceSpine Proliant Posterior Pedicle ... by Choicespine, LP. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K170821 · Choicespine, LP · Orthopedic device
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Jun 2017
Decision
80d
Days
Class 2
Risk

K170821 is an FDA 510(k) clearance for the ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Choicespine, LP (Knoxville, US). The FDA issued a Cleared decision on June 8, 2017 after a review of 80 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 Choicespine, LP devices

Submission Details

510(k) Number K170821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2017
Decision Date June 08, 2017
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
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 615
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K170821.
CapSure® PS System
K172175 · Spine Wave, Inc. · Aug 2017
M.U.S.T. Combined Set Screws
K171758 · Medacta International S.A. · Aug 2017
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
K171813 · L & K Biomed Co., Ltd. · Jul 2017
Palisade™ Pedicular Fixation System
K171438 · Spineology, Inc. · Jun 2017
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
K171170 · Medacta International S.A. · May 2017
Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
K170496 · Stryker Corporation · May 2017