Cleared Traditional

K151154 - FIBERGRAFT BG Morsels

K151154 is an FDA 510(k) clearance for FIBERGRAFT BG Morsels, manufactured by Prosidyan, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K151154 · Prosidyan, Inc. · Orthopedic device
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Nov 2015
Decision
194d
Days
Class 2
Risk

K151154 is an FDA 510(k) clearance for the FIBERGRAFT BG Morsels. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Prosidyan, Inc. (Warren, US). The FDA issued a Cleared decision on November 10, 2015 after a review of 194 days - an extended review 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: 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 Prosidyan, Inc. devices

FDA 510(k) Submission Details - K151154

510(k) Number K151154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2015
Decision Date November 10, 2015
Days to Decision 194 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
72d slower than avg
Panel avg: 122d · This submission: 194d
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 Consultant

Hogan Lovells US LLP
JANICE M HOGAN

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 468
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K151154.
BellaFuse
K151271 · Hans Biomed Corp. · Mar 2016
Vitoss BiModal Bone Graft Substitute Foam Strip
K153608 · Orthovita, Inc. · Feb 2016
Bio2 CLM BG Bioactive Scaffold
K152589 · Bio2 Technologies, Inc. · Jan 2016
AttraX Putty
K151584 · Progentix Orthobiology BV · Oct 2015
Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)
K150064 · Orthogem, Ltd. · Sep 2015
NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)
K152071 · Novabone Products, LLC · Aug 2015