Cleared Traditional

K200290 - Resorbable Mesh Pouch (Ballast MT

K200290 is the FDA 510(k) clearance for Resorbable Mesh Pouch (Ballast MT by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K200290 · SeaSpine Orthopedics Corporation · Orthopedic device
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May 2020
Decision
96d
Days
Class 2
Risk

K200290 is an FDA 510(k) clearance for the Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT). Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Irvine, US). The FDA issued a Cleared decision on May 11, 2020 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - 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 SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K200290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2020
Decision Date May 11, 2020
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 - MQV Filler, Bone Void, Calcium Compound

All 232
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