Cleared Traditional

K150463 - CalcaNail Orthopedic Nail

K150463 is an FDA 510(k) clearance for CalcaNail Orthopedic Nail, manufactured by Fournitures Hospitalieres Industrie. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K150463 · Fournitures Hospitalieres Industrie · Orthopedic device
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May 2015
Decision
88d
Days
Class 2
Risk

K150463 is an FDA 510(k) clearance for the CalcaNail Orthopedic Nail. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Fournitures Hospitalieres Industrie (Quimper, FR). The FDA issued a Cleared decision on May 22, 2015 after a review of 88 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 Fournitures Hospitalieres Industrie devices

FDA 510(k) Submission Details - K150463

510(k) Number K150463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2015
Decision Date May 22, 2015
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

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 365
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K150463.
Affixus Tibial Nailing System
K150867 · Biomet, Inc. · Jun 2015
AOS Clavicle Intramedullary Device
K143204 · Advanced Orthopaedic Solutions, Inc. · Jun 2015
ITST Intertrochanteric/Subtrochanteric Fixation System
K143321 · Zimmer, Inc. · May 2015
CalcaNail Orthopedic Arthrodesis Nail
K150471 · Fournitures Hospitalieres Industrie · May 2015
MICRONAIL Distal Radius System
K150073 · Wrightmedicaltechnologyinc · Feb 2015
OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System
K142451 · Merete Medical GmbH · Feb 2015