Cleared Special

K190283 - PROSTIM Injectable Inductive Graft

K190283 is an FDA 510(k) clearance for PROSTIM Injectable Inductive Graft, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 31-day FDA review.

K190283 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
31d
Days
Class 2
Risk

K190283 is an FDA 510(k) clearance for the PROSTIM Injectable Inductive Graft. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on March 14, 2019 after a review of 31 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K190283

510(k) Number K190283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2019
Decision Date March 14, 2019
Days to Decision 31 days
Submission Type Special
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
91d faster than avg
Panel avg: 122d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K190283.
IGNITE Bone Void Filler
K190482 · Wrightmedicaltechnologyinc · May 2019
NanoBone SBX PUTTY, NanoBone QD
K190110 · Artoss GmbH · Apr 2019
Mineral Collagen Composite Bioactive Moldable
K182074 · Collagen Matrix, Inc. · Mar 2019
FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute
K182670 · Prosidyan, Inc. · Dec 2018
MagnetOs Putty
K181958 · Kuros Biosciences B.V · Dec 2018
PRODENSE Bone Graft Substitute
K182823 · Wrightmedicaltechnologyinc · Nov 2018
K190283 · PROSTIM Injectable Inductive Graft
Download PDF FDA Summary Wrightmedicaltechnolo…