Cleared Traditional

K152527 - Integra DigiFuse Cannulated Intramedullary Fusion System

K152527 is an FDA 510(k) clearance for Integra DigiFuse Cannulated Intramedull..., manufactured by Ascension Orthopedics. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K152527

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
Combination Product No
PCCP Authorized No
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.

HWC Device Classification - Class 2, Special Controls

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 Consultant

Integra Life Sciences
Jayana Kenana

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 - HWC Screw, Fixation, Bone

All 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K152527.
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PHIN-FX Cannulated Lag Screw System
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CrossRoads Screw System
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