Cleared Traditional

SIGNAFUSE Bioactive Strip (SBS) (K233490) - FDA 510(k) Clearance

Also marketed or referenced as:
SIGNAFUSE Putty

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

K233490 · Bioventus, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
39d
Days
Class 2
Risk

K233490 is an FDA 510(k) clearance for the SIGNAFUSE Bioactive Strip (SBS). Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Bioventus, LLC (Durham, US). The FDA issued a Cleared decision on December 5, 2023 after a review of 39 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 Bioventus, LLC devices

Submission Details

510(k) Number K233490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2023
Decision Date December 05, 2023
Days to Decision 39 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
83d faster than avg
Panel avg: 122d · This submission: 39d
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 Consultant

Bruder Consulting & Venture Group
Scott Bruder

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K233490.
MagnetOs Putty
K230736 · Kuros Biosciences B.V · Dec 2023
Tactoset® Injectable Bone Substitute
K231968 · Anika Therapeutics, Inc. · Dec 2023
MagnetOs Easypack Putty
K233607 · Kuros Biosciences B.V · Dec 2023
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