Cleared Traditional

K021556 - SYNTHES 2.4 MM CANNULATED COMPRESSION S...

K021556 is the FDA 510(k) clearance for SYNTHES 2.4 MM CANNULATED COMPRESSION S... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K021556 · Synthes (Usa) · Orthopedic device
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Aug 2002
Decision
88d
Days
Class 2
Risk

K021556 is an FDA 510(k) clearance for the SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW. 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 9, 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 Synthes (Usa) devices

Submission Details

510(k) Number K021556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2002
Decision Date August 09, 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.

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 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K021556.
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
K022234 · Arthrex, Inc. · Oct 2002
SYNTHES 6.5 MM CANNULATED SCREW
K021932 · Synthes (Usa) · Sep 2002
STAYFUSE GT-IP
K022726 · Pioneer Surgical Technology · Sep 2002
LACTOSORB MINI INTERFERENCE SCREW
K021254 · Biomet Orthopedics, Inc. · Jul 2002
SMALL HAMMER TOE PIN
K021828 · Biomet, Inc. · Jul 2002
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
K021832 · Biomet, Inc. · Jun 2002