Cleared Traditional

Adaptable Ortho Innovations Intramedullary Nail System (K210285) - FDA 510(k) Clearance

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

K210285 · Adaptable Ortho Innovations, LLC · Orthopedic device
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Mar 2021
Decision
44d
Days
Class 2
Risk

K210285 is an FDA 510(k) clearance for the Adaptable Ortho Innovations Intramedullary Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Adaptable Ortho Innovations, LLC (Potsdam, US). The FDA issued a Cleared decision on March 18, 2021 after a review of 44 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Adaptable Ortho Innovations, LLC devices

Submission Details

510(k) Number K210285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2021
Decision Date March 18, 2021
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
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 Consultant

Jalex Medical
Kyle Kovach

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 K210285.
Elos® Intramedullary Nailing System
K201147 · Intrauma S.P.A · Jul 2021
Phantom Hindfoot TTC/TC Nail System
K210869 · Paragon 28, Inc. · Jun 2021
Fassier-Duval Telescopic IM System
K211292 · Pega Medical, Inc. · May 2021
T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System
K203819 · Stryker GmbH · Feb 2021
Artemis Proximal Femoral Nail System
K201379 · Glw, Inc. · Feb 2021
FITBONE(R) TAA
K203399 · Wittenstein Intens GmbH · Feb 2021