Cleared Special

Flow-Nail (K221115) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221115 · Flow-Fx, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
28d
Days
Class 2
Risk

K221115 is an FDA 510(k) clearance for the Flow-Nail. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Flow-Fx, LLC (Mokena, US). The FDA issued a Cleared decision on May 13, 2022 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Flow-Fx, LLC devices

Submission Details

510(k) Number K221115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2022
Decision Date May 13, 2022
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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
Hollace S. Rhodes

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 - HSB Rod, Fixation, Intramedullary And Accessories

All 262
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K221115.
Artemis Proximal Femoral Nail System
K221489 · Glw, Inc. · Oct 2022
AUTOBAHN(R) EVO Femoral Nails
K220659 · Globus Medical, Inc. · Sep 2022
Pediatric Nailing Platform Femur
K220679 · OrthoPediatrics Corp. · Jul 2022
Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
K213328 · Stryker GmbH · Feb 2022
GPC Intraheal Intramedullary Nailing System
K203811 · Gpc Medical Limited · Feb 2022
The Progen™ Trochanteric Nail System
K211086 · Ortho Development Corporation · Dec 2021