Cleared Traditional

K212139 - Admiral ACP System

K212139 is the FDA 510(k) clearance for Admiral ACP System by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K212139 · SeaSpine Orthopedics Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
55d
Days
Class 2
Risk

K212139 is an FDA 510(k) clearance for the Admiral ACP System. 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 September 1, 2021 after a review of 55 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 K212139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2021
Decision Date September 01, 2021
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 K212139.
NuVasive Anterior Cervical Plate Systems
K212446 · Nu Vasive, Incorporated · Nov 2021
Quantum Anterior Cervical Plate
K210424 · Nvision Biomedical Technologies, Inc. · Oct 2021
EMERGE™ Anterior Cervical Plate System
K212405 · Evolution Spine · Sep 2021
Shoreline Threaded TruProfile® Plate
K211903 · SeaSpine Orthopedics Corporation · Aug 2021
Prase-C Anterior Cervical Plate System
K211205 · Gbs Commonwealth Co., Ltd. · Aug 2021
Fixxsure Anterior Lumbar Plate and Screw System
K211932 · Oak Tree Engineering, LLC · Jul 2021