Cleared Traditional

K020159 - SMITH & NEPHEW TWINFIX TI QUICK T

K020159 is the FDA 510(k) clearance for SMITH & NEPHEW TWINFIX TI QUICK T by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K020159 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
68d
Days
Class 2
Risk

K020159 is an FDA 510(k) clearance for the SMITH & NEPHEW TWINFIX TI QUICK T. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on March 26, 2002 after a review of 68 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K020159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2002
Decision Date March 26, 2002
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
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 564
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K020159.
BIOSCREW XTRALOK
K013131 · Linvatec Corp. · Jun 2002
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K020377 · Linvatec Corp. · May 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
K020043 · Arthrex, Inc. · Apr 2002
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K020446 · American Medical Systems, Inc. · Mar 2002
LORENZ SELF DRILLING SCREWS
K013954 · Walter Lorenz Surgical, Inc. · Feb 2002
BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K013107 · Karl Storz Endoscopy · Feb 2002