Cleared Traditional

Osteo3 ZP Putty (K193075) - FDA 510(k) Clearance

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

K193075 · Sirakoss , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
218d
Days
Class 2
Risk

K193075 is an FDA 510(k) clearance for the Osteo3 ZP Putty. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Sirakoss , Ltd. (Aberdeen, GB). The FDA issued a Cleared decision on June 9, 2020 after a review of 218 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 Sirakoss , Ltd. devices

Submission Details

510(k) Number K193075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2019
Decision Date June 09, 2020
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
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

PaxMed International, LLC
Kevin A Thomas

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 491
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K193075.
Device 300419 Strip
K260364 · Geistlich Pharma AG · Jun 2026
JAZBI™ Resorbable Bone Void Filler
K252797 · Sdip Innovations Pty, Ltd. · May 2026
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip
K261008 · Stryker Spine · Apr 2026
Adaptos®Fuse Bone Graft
K253524 · Biomendex OY · Feb 2026
FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute
K253147 · Prosidyan, Inc. · Oct 2025
Mg OSTEOINJECT™
K251522 · Bone Solutions, Inc. · Oct 2025