Cleared Traditional

K241564 - Actifuse ABX

Also marketed or referenced as:
Actifuse MIS Actifuse Shape ALTAPORE ALTAPORE SHAPE ALTAPORE MIS

K241564 is the FDA 510(k) clearance for Actifuse ABX by Baxter Healthcare Corporation. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K241564 · Baxter Healthcare Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
63d
Days
Class 2
Risk

K241564 is an FDA 510(k) clearance for the Actifuse ABX. 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 August 2, 2024 after a review of 63 days - a notably fast clearance cycle.

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: 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 Baxter Healthcare Corporation devices

Submission Details

510(k) Number K241564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2024
Decision Date August 02, 2024
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 231
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