Cleared Traditional

K022597 - K-FIX

K022597 is an FDA 510(k) clearance for K-FIX, manufactured by New Deal, S.A.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K022597 · New Deal, S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
88d
Days
Class 2
Risk

K022597 is an FDA 510(k) clearance for the K-FIX. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by New Deal, S.A. (Potomac, US). The FDA issued a Cleared decision on November 1, 2002 after a review of 88 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 New Deal, S.A. devices

FDA 510(k) Submission Details - K022597

510(k) Number K022597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2002
Decision Date November 01, 2002
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 178
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K022597.
HANSSON PIN SYSTEM
K033968 · Howmedica Osteonics Corp. · Feb 2004
ACE NANCY NAIL
K032687 · DePuy Orthopaedics, Inc. · Oct 2003
INION OTPS BIODEGRADABLE PIN
K031712 · Inion , Ltd. · Aug 2003
NEWDEAL K WIRE
K022599 · New Deal, S.A. · Oct 2002
2MM PEDIATRIC FLEX NAIL
K022531 · Biomet, Inc. · Aug 2002
FIXATION (STEINMANN) PINS
K013888 · Miltex, Inc. · May 2002