Cleared Traditional

K063070 - APERFIX TIBIAL IMPLANT WITH INSERTER

K063070 is the FDA 510(k) clearance for APERFIX TIBIAL IMPLANT WITH INSERTER by Cayenne Medical, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K063070 · Cayenne Medical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2006
Decision
69d
Days
Class 2
Risk

K063070 is an FDA 510(k) clearance for the APERFIX TIBIAL IMPLANT WITH INSERTER. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Cayenne Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on December 14, 2006 after a review of 69 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 Cayenne Medical, Inc. devices

Submission Details

510(k) Number K063070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2006
Decision Date December 14, 2006
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
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 556
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K063070.
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