Cleared Traditional

The Progen™ Trochanteric Nail System (K211086) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211086 · Ortho Development Corporation · Orthopedic device
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Dec 2021
Decision
253d
Days
Class 2
Risk

K211086 is an FDA 510(k) clearance for the The Progen™ Trochanteric Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on December 21, 2021 after a review of 253 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Ortho Development Corporation devices

Submission Details

510(k) Number K211086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2021
Decision Date December 21, 2021
Days to Decision 253 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
131d slower than avg
Panel avg: 122d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 259
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K211086.
Flow-Nail
K221115 · Flow-Fx, LLC · May 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
Flex-Thread™ Distal Fibula lntramedullary Nail System
K212030 · Flower Orthopedics Corporation Dba Conventus Flower · Jul 2021
Elos® Intramedullary Nailing System
K201147 · Intrauma S.P.A · Jul 2021
Phantom Hindfoot TTC/TC Nail System
K210869 · Paragon 28, Inc. · Jun 2021