Cleared Traditional

K191513 - Altapore Shape

K191513 is an FDA 510(k) clearance for Altapore Shape, manufactured by Baxter Healthcare Corporation. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K191513 · Baxter Healthcare Corporation · Orthopedic device
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Oct 2019
Decision
134d
Days
Class 2
Risk

K191513 is an FDA 510(k) clearance for the Altapore Shape. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on October 19, 2019 after a review of 134 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 Baxter Healthcare Corporation devices

FDA 510(k) Submission Details - K191513

510(k) Number K191513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2019
Decision Date October 19, 2019
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
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 K191513.
Altapore
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NuVasive AttraX Putty
K191974 · Nu Vasive, Incorporated · Nov 2019
Sorrento Bone Graft Substitute
K191074 · Xenco Medical, LLC · Sep 2019
Morpheus-C
K190371 · Biogennix, LLC · Aug 2019
BonAlive Granules
K191274 · Bonalive Biomaterials, Ltd. · Aug 2019