Cleared Traditional

K191966 - NewPrim System

K191966 is an FDA 510(k) clearance for NewPrim System, manufactured by Brm Extremities. The device is a Class 2 Orthopedic device with product code KWH cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K191966 · Brm Extremities · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
205d
Days
Class 2
Risk

K191966 is an FDA 510(k) clearance for the NewPrim System. Classified as Prosthesis, Toe, Constrained, Polymer (product code KWH), Class II - Special Controls.

Submitted by Brm Extremities (Milano, US). The FDA issued a Cleared decision on February 13, 2020 after a review of 205 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3720 - 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 Brm Extremities devices

FDA 510(k) Submission Details - K191966

510(k) Number K191966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2019
Decision Date February 13, 2020
Days to Decision 205 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
83d slower than avg
Panel avg: 122d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWH Device Classification - Class 2, Special Controls

Product Code KWH Prosthesis, Toe, Constrained, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3720
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

Mcra, LLC
Margeaux Roger

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 - KWH Prosthesis, Toe, Constrained, Polymer

All 10
Devices cleared under the same product code (KWH) and FDA review panel - the closest regulatory comparables to K191966.
Fusion Silastic System
K190136 · Fusion Orthopedics, LLC · Oct 2019
RTS Lesser MTP Implant System
K173491 · In2bones USA, LLC · Feb 2018
RTS Flexible 1 MPJ Implant w/Grommets
K153609 · In2bones USA, LLC · Sep 2016
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022887 · Osteomed Corp. · Nov 2002
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022886 · Osteomed Corp. · Nov 2002
ASCENT KNEE SYSTEM
K994326 · Biomet Manufacturing, Inc. · Jan 2000