Cleared Traditional

OrthoGold (K191961) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191961 · Tissue Regeneration Technologies · General & Plastic Surgery device
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Nov 2019
Decision
126d
Days
Class 2
Risk

K191961 is an FDA 510(k) clearance for the OrthoGold. Classified as Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers (product code PZL), Class II - Special Controls.

Submitted by Tissue Regeneration Technologies (Woodstock, US). The FDA issued a Cleared decision on November 26, 2019 after a review of 126 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4685 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Tissue Regeneration Technologies devices

Submission Details

510(k) Number K191961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2019
Decision Date November 26, 2019
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4685
Definition Treatment Of Diabetic Foot Ulcers
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Msquared Associates, Inc.
Jennifer A Daudelin

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 - PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

All 7
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