Cleared Special

K022531 - 2MM PEDIATRIC FLEX NAIL

K022531 is an FDA 510(k) clearance for 2MM PEDIATRIC FLEX NAIL, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Special 510(k) pathway after a 26-day FDA review.

K022531 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
26d
Days
Class 2
Risk

K022531 is an FDA 510(k) clearance for the 2MM PEDIATRIC FLEX NAIL. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 26, 2002 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet, Inc. devices

FDA 510(k) Submission Details - K022531

510(k) Number K022531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2002
Decision Date August 26, 2002
Days to Decision 26 days
Submission Type Special
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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 173
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K022531.
INION OTPS BIODEGRADABLE PIN
K031712 · Inion , Ltd. · Aug 2003
K-FIX
K022597 · New Deal, S.A. · Nov 2002
NEWDEAL K WIRE
K022599 · New Deal, S.A. · Oct 2002
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