Cleared Traditional

K200290 - Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)

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

K200290 · SeaSpine Orthopedics Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K200290

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.

MQV Device Classification - Class 2, Special Controls

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 407
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K200290.
Altapore MIS
K201464 · Baxter Healthcare Corporation · Jun 2020
SIGNAFUSE Bioactive Bone Graft
K193513 · Bioventus · Jun 2020
Osteo3 ZP Putty
K193075 · Sirakoss , Ltd. · Jun 2020
ALTAPORE SHAPE
K200640 · Baxter Healthcare Corporation · May 2020
DB-Orthopedics
K200752 · Dimensional Bioceramics, LLC · Apr 2020
Agilon Strip
K193487 · Biogennix, LLC · Mar 2020