Cleared Traditional

K152527 - Integra DigiFuse Cannulated Intramedull...

K152527 is the FDA 510(k) clearance for Integra DigiFuse Cannulated Intramedull... by Ascension Orthopedics. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K152527 · Ascension Orthopedics · Orthopedic device
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Oct 2015
Decision
56d
Days
Class 2
Risk

K152527 is an FDA 510(k) clearance for the Integra DigiFuse Cannulated Intramedullary Fusion System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Ascension Orthopedics (Austin, US). The FDA issued a Cleared decision on October 29, 2015 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Ascension Orthopedics devices

Submission Details

510(k) Number K152527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2015
Decision Date October 29, 2015
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 557
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K152527.
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