Cleared Traditional

Catalyst Bone Void Filler (K232315) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232315 · Ossdsign AB · Orthopedic device
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Sep 2023
Decision
44d
Days
Class 2
Risk

K232315 is an FDA 510(k) clearance for the Catalyst Bone Void Filler. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Ossdsign AB (Uppsala, IE). The FDA issued a Cleared decision on September 15, 2023 after a review of 44 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 Ossdsign AB devices

Submission Details

510(k) Number K232315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2023
Decision Date September 15, 2023
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
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 201
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K232315.
MagnetOs Flex Matrix
K233245 · Kuros Biosciences B.V · Nov 2023
OsteoFlo® HydroPutty™
K231716 · SurGenTec, LLC · Oct 2023
Cove Strip, OsteoCove Strip
K232668 · SeaSpine Orthopedics Corporation · Sep 2023
Cove Putty, OsteoCove Putty
K231030 · SeaSpine Orthopedics Corporation · Sep 2023
Montage Flowable Settable, Resorbable Bone Paste
K231270 · Orthocon, Inc. · Sep 2023
Montage-QS Settable, Resorbable Bone Putty
K231903 · Orthocon, Inc. · Aug 2023