Cleared Traditional

K082375 - ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM

K082375 is an FDA 510(k) clearance for ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL ..., manufactured by OrthoPediatrics Corp.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K082375 · OrthoPediatrics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
60d
Days
Class 2
Risk

K082375 is an FDA 510(k) clearance for the ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on October 17, 2008 after a review of 60 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 OrthoPediatrics Corp. devices

FDA 510(k) Submission Details - K082375

510(k) Number K082375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2008
Decision Date October 17, 2008
Days to Decision 60 days
Submission Type Traditional
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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 172
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K082375.
STRYKER SONICPIN SYSTEM
K091955 · Howmedica Osteonics Corp. · Apr 2010
APTUS K-WIRE SYSTEM
K092038 · Medartis AG · Sep 2009
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
K083490 · Biopro, Inc. · Mar 2009
STARR FRAME STEINMANN PIN
K082017 · Starr Frame, LLC · Oct 2008
ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM
K080879 · Bioretec, Ltd. · Jun 2008
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
K081097 · Orthopediatrics, LLC · Jun 2008