Cleared Traditional

K172330 - Blustone Synergy Silica System

K172330 is an FDA 510(k) clearance for Blustone Synergy Silica System, manufactured by Blustone Synergy. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K172330 · Blustone Synergy · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
141d
Days
Class 2
Risk

K172330 is an FDA 510(k) clearance for the Blustone Synergy Silica System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Blustone Synergy (Pueblo, US). The FDA issued a Cleared decision on December 21, 2017 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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.

FDA 510(k) Submission Details - K172330

510(k) Number K172330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2017
Decision Date December 21, 2017
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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

Kaedon Consulting, LLC
Lisa Peterson

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 - MQP Spinal Vertebral Body Replacement Device

All 278
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K172330.
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