Cleared Special

Flex-Thread™ Distal Fibula lntramedullary Nail System (K212030) - FDA 510(k) Clearance

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

K212030 · Flower Orthopedics Corporation Dba Conventus Flower · Orthopedic device
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Jul 2021
Decision
24d
Days
Class 2
Risk

K212030 is an FDA 510(k) clearance for the Flex-Thread™ Distal Fibula lntramedullary Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Flower Orthopedics Corporation Dba Conventus Flower (Horsham, US). The FDA issued a Cleared decision on July 23, 2021 after a review of 24 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 Flower Orthopedics Corporation Dba Conventus Flower devices

Submission Details

510(k) Number K212030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2021
Decision Date July 23, 2021
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 260
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K212030.
Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
K213328 · Stryker GmbH · Feb 2022
GPC Intraheal Intramedullary Nailing System
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The Progen™ Trochanteric Nail System
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Phantom Hindfoot TTC/TC Nail System
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Fassier-Duval Telescopic IM System
K211292 · Pega Medical, Inc. · May 2021