Cleared Traditional

K073426 - APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM

Also marketed or referenced as:
7-12 MM X 25 MM 7-12 MM X 30 MM

K073426 is the FDA 510(k) clearance for APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM by Cayenne Medical, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K073426 · Cayenne Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
76d
Days
Class 2
Risk

K073426 is an FDA 510(k) clearance for the APERFIX INTERFERENCE SCREW 7-12 MM X 20 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 February 19, 2008 after a review of 76 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 K073426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2007
Decision Date February 19, 2008
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 K073426.
AAP CANNULATED SCREW AND DARCO HEADED SCREW
K080101 · Aap Implantate AG · Mar 2008
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K080352 · Depuy Mitek, A Johnson & Johnson Company · Mar 2008
TWINFIX PK FP SUTURE ANCHOR
K073509 · Smith & Nephew, Inc. · Mar 2008
STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS
K071157 · Stryker Endoscopy · Sep 2007
MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
K071437 · KARL STORZ Endoscopy-America, Inc. · Sep 2007
HEALIX ANCHOR
K071481 · Depuy Mitek, A Johnson & Johnson Company · Aug 2007