Cleared Traditional

K211903 - Shoreline Threaded TruProfile Plate

K211903 is the FDA 510(k) clearance for Shoreline Threaded TruProfile Plate by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K211903 · SeaSpine Orthopedics Corporation · Orthopedic device
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Aug 2021
Decision
70d
Days
Class 2
Risk

K211903 is an FDA 510(k) clearance for the Shoreline Threaded TruProfile® Plate. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on August 30, 2021 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K211903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2021
Decision Date August 30, 2021
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 434
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K211903.
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