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DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc. vs Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations: FDAPulse comparison

Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations's review days of 192 is 1.1x DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc.'s 181 (68th percentile). DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc. is dated 2026-09-23; Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations 2026-10-19.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe

How does DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc. compare to Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations?

FieldDynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc.Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations
Record510(k) clearance510(k) clearance
510(k) numberK260995K261189
DeviceDynaNail Helix® Fixation SystemFreedom Nail Ankle Fusion System
ApplicantMedShape, Inc.McGinley Orthopaedic Innovations
Specialty / panelOrthopedicOrthopedic
Product codeHWCHSB
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-03-262026-04-10
Decision date2026-09-232026-10-19
Review time (days)181192
Third-party reviewNoNo
Applicant locationAtlanta, GA, USCasper, WY, US
amount percentile64th68th
Predicate Speed & CAPA Advisory Opportunity Score48/10048/100
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Official records: DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc. · Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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