Cleared Traditional

K083607 - APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083607 · Cayenne Medical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2009
Decision
89d
Days
Class 2
Risk

K083607 is an FDA 510(k) clearance for the APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Cayenne Medical, Inc. (Scottsdale, US). The FDA issued a Cleared decision on March 4, 2009 after a review of 89 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 K083607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2008
Decision Date March 04, 2009
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 1054
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K083607.
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