Cleared Traditional

K002271 - 2.4MM CORTEX SCREW, SELF-TAPPING

K002271 is an FDA 510(k) clearance for 2.4MM CORTEX SCREW, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K002271 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
30d
Days
Class 2
Risk

K002271 is an FDA 510(k) clearance for the 2.4MM CORTEX SCREW, SELF-TAPPING. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on August 25, 2000 after a review of 30 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K002271

510(k) Number K002271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2000
Decision Date August 25, 2000
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 923
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K002271.
BIOLOK SCREW, BIOSTEON SCREW
K003641 · Biocomposites, Ltd. · Feb 2001
HOWMEDICA OSTEONICS SHOULDER SCREW
K002654 · Howmedica Osteonics Corp. · Sep 2000
BIOLOK SCREW
K002070 · Biocomposites, Ltd. · Aug 2000
STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K993166 · Stryker Endoscopy · Aug 2000
THE KALIX IMPLANT
K001231 · New Deal, S.A. · Jul 2000
BIOLOK SCREW
K993630 · Encore Orthopedics, Inc. · Apr 2000