Cleared Traditional

K012161 - FLEX-NAILS

K012161 is an FDA 510(k) clearance for FLEX-NAILS, manufactured by Fixano SA. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K012161 · Fixano SA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
44d
Days
Class 2
Risk

K012161 is an FDA 510(k) clearance for the FLEX-NAILS. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Fixano SA (La Jolla, US). The FDA issued a Cleared decision on August 24, 2001 after a review of 44 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 Fixano SA devices

FDA 510(k) Submission Details - K012161

510(k) Number K012161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2001
Decision Date August 24, 2001
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 152
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K012161.
FIXATION (STEINMANN) PINS
K013888 · Miltex, Inc. · May 2002
RESORBABLE LACTOSORB-L ACL CROSSPIN
K014305 · Arthrotek, Inc. · Mar 2002
RIDIDFIX 2.7MM BTB CROSS PIN KIT
K013781 · Mitek Products · Feb 2002
RESORBABLE BONE PINS
K011522 · Biomet, Inc. · Jul 2001
PLLA PIN
K010983 · Bionx Implants, Inc. · Jun 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527 · Synthes (Usa) · Apr 2001